Trial Outcomes & Findings for A Phase 2a Study to Evaluate EDP-938 in the Virus Challenge Model (NCT NCT03691623)

Last Updated: 2022-05-03

Results Overview

Measured in nasal washes by quantitative reverse transcription polymerase chain reaction (RT-qPCR) in participants inoculated with respiratory syncytial virus-A (RSV-A) Memphis 37b.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

179 participants

Primary outcome timeframe

Twice daily on Day 2 through Day 11 and once on Day 12

Results posted on

2022-05-03

Participant Flow

A total of 179 participants enrolled in the trial at one site in the United Kingdom from October 2018 to October 2019.

For Part 1, 115 participants were inoculated with respiratory syncytial virus-A (RSV-A) Memphis 37b and randomized, of whom 114 were treated. For Part 2, 64 participants were inoculated with RSV-A Memphis 37b of whom 63 were randomized and treated. The 178 randomized participants are included in the participant flow. One inoculated participant was not randomized to a specific treatment assignment and is not included in participant flow.

Participant milestones

Participant milestones
Measure	Part 1: EDP-938 600 mg Participants were administered EDP-938 oral suspension of 600 mg followed after 12 hours by a placebo once daily (OD) for a total of 10 doses over 5 days.	Part 1: EDP-938 500 mg Then 300 mg Participants were administered EDP-938 oral suspension as a single loading dose of 500 mg followed after 12 hours by EDP-938 300 mg twice daily (BID) (every 12 hours) for a total of 10 doses over 5 days.	Part 1: Placebo Participants were administered a placebo BID (every 12 hours) for a total of 10 doses over 5 days.	Part 2: EDP-938 600 mg Then 300 mg Participants were administered a single loading dose of 600 mg EDP-938, followed by EDP-938 300 mg OD, and with dosing for 5 days.	Part 2: EDP-938 400 mg Then 200 mg Participants were administered a single loading dose of 400 mg EDP-938 followed by EDP-938 200 mg at 12 hours, then EDP-938 200 mg BID, and with dosing for 5 days.	Part 2: Placebo Participants were administered a placebo BID for 5 days, with dosing at 12 hour intervals.
Overall Study STARTED	39	38	38	21	21	21
Overall Study Inoculated With Challenge Virus	39	38	38	21	21	21
Overall Study Received Treatment	38	38	38	21	21	21
Overall Study COMPLETED	39	38	38	21	21	21
Overall Study NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Phase 2a Study to Evaluate EDP-938 in the Virus Challenge Model

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1: EDP-938 600 mg n=38 Participants Participants were administered EDP-938 oral suspension of 600 mg followed after 12 hours by a placebo once daily (OD) for a total of 10 doses over 5 days.	Part 1: EDP-938 500 mg Then 300 mg n=38 Participants Participants were administered EDP-938 oral suspension as a single loading dose of 500 mg followed after 12 hours by EDP-938 300 mg twice daily (BID) (every 12 hours) for a total of 10 doses over 5 days.	Part 1: Placebo n=38 Participants Participants were administered a placebo BID (every 12 hours) for a total of 10 doses over 5 days.	Part 2: EDP-938 600 mg Then 300 mg n=21 Participants Participants were administered a single loading dose of 600 mg EDP-938, followed by EDP-938 300 mg OD, and with dosing for 5 days.	Part 2: EDP-938 400 mg Then 200 mg n=21 Participants Participants were administered a single loading dose of 400 mg EDP-938 followed by EDP-938 200 mg at 12 hours, then EDP-938 200 mg BID, and with dosing for 5 days.	Part 2: Placebo n=21 Participants Participants were administered a placebo BID for 5 days, with dosing at 12 hour intervals.	Total n=177 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants	0 Participants n=146 Participants	0 Participants n=19 Participants	0 Participants n=147 Participants
Age, Categorical Between 18 and 65 years	38 Participants n=39 Participants	38 Participants n=41 Participants	38 Participants n=35 Participants	21 Participants n=31 Participants	21 Participants n=146 Participants	21 Participants n=19 Participants	177 Participants n=147 Participants
Age, Categorical >=65 years	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants	0 Participants n=146 Participants	0 Participants n=19 Participants	0 Participants n=147 Participants
Sex: Female, Male Female	13 Participants n=39 Participants	18 Participants n=41 Participants	13 Participants n=35 Participants	10 Participants n=31 Participants	11 Participants n=146 Participants	9 Participants n=19 Participants	74 Participants n=147 Participants
Sex: Female, Male Male	25 Participants n=39 Participants	20 Participants n=41 Participants	25 Participants n=35 Participants	11 Participants n=31 Participants	10 Participants n=146 Participants	12 Participants n=19 Participants	103 Participants n=147 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants	0 Participants n=146 Participants	0 Participants n=19 Participants	0 Participants n=147 Participants
Race (NIH/OMB) Asian	1 Participants n=39 Participants	1 Participants n=41 Participants	2 Participants n=35 Participants	1 Participants n=31 Participants	1 Participants n=146 Participants	0 Participants n=19 Participants	6 Participants n=147 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants	0 Participants n=146 Participants	0 Participants n=19 Participants	0 Participants n=147 Participants
Race (NIH/OMB) Black or African American	0 Participants n=39 Participants	1 Participants n=41 Participants	2 Participants n=35 Participants	0 Participants n=31 Participants	1 Participants n=146 Participants	0 Participants n=19 Participants	4 Participants n=147 Participants
Race (NIH/OMB) White	33 Participants n=39 Participants	32 Participants n=41 Participants	31 Participants n=35 Participants	18 Participants n=31 Participants	17 Participants n=146 Participants	19 Participants n=19 Participants	150 Participants n=147 Participants
Race (NIH/OMB) More than one race	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants	0 Participants n=146 Participants	0 Participants n=19 Participants	0 Participants n=147 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=39 Participants	4 Participants n=41 Participants	3 Participants n=35 Participants	2 Participants n=31 Participants	2 Participants n=146 Participants	2 Participants n=19 Participants	17 Participants n=147 Participants

PRIMARY outcome

Timeframe: Twice daily on Day 2 through Day 11 and once on Day 12

Measured in nasal washes by quantitative reverse transcription polymerase chain reaction (RT-qPCR) in participants inoculated with respiratory syncytial virus-A (RSV-A) Memphis 37b.

Outcome measures

Outcome measures
Measure	Part 1: EDP-938 600 mg n=25 Participants Participants were administered EDP-938 oral suspension of 600 mg followed after 12 hours by a placebo once daily (OD) for a total of 10 doses over 5 days.	Part 1: EDP-938 500 mg Then 300 mg n=31 Participants Participants were administered EDP-938 oral suspension as a single loading dose of 500 mg followed after 12 hours by EDP-938 300 mg twice daily (BID) (every 12 hours) for a total of 10 doses over 5 days.	Part 1: Placebo n=30 Participants Participants were administered a placebo BID (every 12 hours) for a total of 10 doses over 5 days.	Part 2: EDP-938 600 mg Then 300 mg n=15 Participants Participants were administered a single loading dose of 600 mg EDP-938, followed by EDP-938 300 mg OD, and with dosing for 5 days.	Part 2: EDP-938 400 mg Then 200 mg n=11 Participants Participants were administered a single loading dose of 400 mg EDP-938 followed by EDP-938 200 mg at 12 hours, then EDP-938 200 mg BID, and with dosing for 5 days.	Part 2: Placebo n=12 Participants Participants were administered a placebo BID for 5 days, with dosing at 12 hour intervals.
Area Under the Curve (AUC) of Respiratory Syncytial Virus (RSV) Viral Load	134.70 hours*log10 copies/milliliter (mL) Geometric Coefficient of Variation 85.1	113.51 hours*log10 copies/milliliter (mL) Geometric Coefficient of Variation 99.9	624.30 hours*log10 copies/milliliter (mL) Geometric Coefficient of Variation 51.7	80.61 hours*log10 copies/milliliter (mL) Geometric Coefficient of Variation 112.1	160.81 hours*log10 copies/milliliter (mL) Geometric Coefficient of Variation 63.3	808.28 hours*log10 copies/milliliter (mL) Geometric Coefficient of Variation 37.1

SECONDARY outcome

Timeframe: Three times daily on Day 0 to Day 11, once on Day 12

Total symptom scores (from the 10-item Diary Card) were used to calculate the AUC. Each individual symptom score was graded on a scale of 0-3, where Grade 0 is absence, Grade 1 is just noticeable, Grade 2 is bothersome but does not prevent participation in activities and Grade 3 is bothersome and interferes with activities: * Runny nose * Stuffy nose * Sneezing * Sore throat * Earache * Malaise (Tiredness) * Cough * Shortness of breath * Headache * Muscle/ joint ache/ stiffness Total symptom score is the sum of individual symptom scores with a potential range of 0 (best) to 30 (worst). Data presented is hours x score.

Outcome measures

Outcome measures
Measure	Part 1: EDP-938 600 mg n=25 Participants Participants were administered EDP-938 oral suspension of 600 mg followed after 12 hours by a placebo once daily (OD) for a total of 10 doses over 5 days.	Part 1: EDP-938 500 mg Then 300 mg n=31 Participants Participants were administered EDP-938 oral suspension as a single loading dose of 500 mg followed after 12 hours by EDP-938 300 mg twice daily (BID) (every 12 hours) for a total of 10 doses over 5 days.	Part 1: Placebo n=30 Participants Participants were administered a placebo BID (every 12 hours) for a total of 10 doses over 5 days.	Part 2: EDP-938 600 mg Then 300 mg n=15 Participants Participants were administered a single loading dose of 600 mg EDP-938, followed by EDP-938 300 mg OD, and with dosing for 5 days.	Part 2: EDP-938 400 mg Then 200 mg n=11 Participants Participants were administered a single loading dose of 400 mg EDP-938 followed by EDP-938 200 mg at 12 hours, then EDP-938 200 mg BID, and with dosing for 5 days.	Part 2: Placebo n=12 Participants Participants were administered a placebo BID for 5 days, with dosing at 12 hour intervals.
Area Under the Curve (AUC) of Total Symptom Score	61.18 hours*score Geometric Coefficient of Variation 347.8	37.36 hours*score Geometric Coefficient of Variation 1640.1	252.49 hours*score Geometric Coefficient of Variation 243.9	26.70 hours*score Geometric Coefficient of Variation 730.2	27.81 hours*score Geometric Coefficient of Variation 436.8	232.53 hours*score Geometric Coefficient of Variation 530.9

SECONDARY outcome

Timeframe: Day 2 to Day 12

Peak total symptom score was defined as the highest total symptom score between first dose of study drug and Day 12. Values presented are a sum of individual symptom scores, with a potential range of 0 (best) to 30 (worst). Total symptom scores at the time of the first dose of study drug can be before or after dosing. Measured by the 10-item Diary Card. Each individual symptom score was graded on a scale of 0-3, where Grade 0 is absence, Grade 1 is just noticeable, Grade 2 is bothersome but does not prevent participation in activities and Grade 3 is bothersome and interferes with activities: * Runny nose * Stuffy nose * Sneezing * Sore throat * Earache * Malaise (Tiredness) * Cough * Shortness of breath * Headache * Muscle/ joint ache/ stiffness

Outcome measures

Outcome measures
Measure	Part 1: EDP-938 600 mg n=25 Participants Participants were administered EDP-938 oral suspension of 600 mg followed after 12 hours by a placebo once daily (OD) for a total of 10 doses over 5 days.	Part 1: EDP-938 500 mg Then 300 mg n=31 Participants Participants were administered EDP-938 oral suspension as a single loading dose of 500 mg followed after 12 hours by EDP-938 300 mg twice daily (BID) (every 12 hours) for a total of 10 doses over 5 days.	Part 1: Placebo n=30 Participants Participants were administered a placebo BID (every 12 hours) for a total of 10 doses over 5 days.	Part 2: EDP-938 600 mg Then 300 mg n=15 Participants Participants were administered a single loading dose of 600 mg EDP-938, followed by EDP-938 300 mg OD, and with dosing for 5 days.	Part 2: EDP-938 400 mg Then 200 mg n=11 Participants Participants were administered a single loading dose of 400 mg EDP-938 followed by EDP-938 200 mg at 12 hours, then EDP-938 200 mg BID, and with dosing for 5 days.	Part 2: Placebo n=12 Participants Participants were administered a placebo BID for 5 days, with dosing at 12 hour intervals.
Peak Total Symptom Score	2.3 Scores on a scale Geometric Coefficient of Variation 53.9	1.9 Scores on a scale Geometric Coefficient of Variation 89.8	4.9 Scores on a scale Geometric Coefficient of Variation 77.9	1.6 Scores on a scale Geometric Coefficient of Variation 68.5	1.8 Scores on a scale Geometric Coefficient of Variation 55.6	4.2 Scores on a scale Geometric Coefficient of Variation 85.8

SECONDARY outcome

Timeframe: Day 2 to Day 9

Population: Intent to Treat Infected (ITT-I) Analysis Set, defined as all randomised participants who received challenge virus and at least one dose of investigational medicinal product (IMP), and who met the criterion for laboratory confirmed respiratory syncytial virus (RSV) infection as per the definition of laboratory confirmed infection. For cases of 0 participants analyzed, data were not collected from any participants for that time point.

Measured by the 10-item Diary Card. Each individual symptom score was graded on a scale of 0-3, where Grade 0 is absence, Grade 1 is just noticeable, Grade 2 is bothersome but does not prevent participation in activities and Grade 3 is bothersome and interferes with activities. Total symptom score is the sum of individual symptom scores with a potential range of 0 (best) to 30 (worst). * Runny nose * Stuffy nose * Sneezing * Sore throat * Earache * Malaise (Tiredness) * Cough * Shortness of breath * Headache * Muscle/ joint ache/ stiffness

Outcome measures

Outcome measures
Measure	Part 1: EDP-938 600 mg n=25 Participants Participants were administered EDP-938 oral suspension of 600 mg followed after 12 hours by a placebo once daily (OD) for a total of 10 doses over 5 days.	Part 1: EDP-938 500 mg Then 300 mg n=31 Participants Participants were administered EDP-938 oral suspension as a single loading dose of 500 mg followed after 12 hours by EDP-938 300 mg twice daily (BID) (every 12 hours) for a total of 10 doses over 5 days.	Part 1: Placebo n=30 Participants Participants were administered a placebo BID (every 12 hours) for a total of 10 doses over 5 days.	Part 2: EDP-938 600 mg Then 300 mg n=15 Participants Participants were administered a single loading dose of 600 mg EDP-938, followed by EDP-938 300 mg OD, and with dosing for 5 days.	Part 2: EDP-938 400 mg Then 200 mg n=11 Participants Participants were administered a single loading dose of 400 mg EDP-938 followed by EDP-938 200 mg at 12 hours, then EDP-938 200 mg BID, and with dosing for 5 days.	Part 2: Placebo n=12 Participants Participants were administered a placebo BID for 5 days, with dosing at 12 hour intervals.
Total Symptom Score Relative Day 3 Assessment 2	0.4 Scores on a scale Geometric Coefficient of Variation 144.3	0.6 Scores on a scale Geometric Coefficient of Variation 175.2	2.7 Scores on a scale Geometric Coefficient of Variation 90.5	0.3 Scores on a scale Geometric Coefficient of Variation 207.0	0.3 Scores on a scale Geometric Coefficient of Variation 237.1	2.3 Scores on a scale Geometric Coefficient of Variation 101.0
Total Symptom Score Relative Day 4 Assessment 1	0.3 Scores on a scale Geometric Coefficient of Variation 177.1	0.5 Scores on a scale Geometric Coefficient of Variation 154.9	2.3 Scores on a scale Geometric Coefficient of Variation 103.8	0.2 Scores on a scale Geometric Coefficient of Variation 343.9	0.2 Scores on a scale Geometric Coefficient of Variation 254.2	1.9 Scores on a scale Geometric Coefficient of Variation 92.6
Total Symptom Score Relative Day 5 Assessment 1	0.2 Scores on a scale Geometric Coefficient of Variation 228.2	0.5 Scores on a scale Geometric Coefficient of Variation 158.9	1.6 Scores on a scale Geometric Coefficient of Variation 108.3	0.2 Scores on a scale Geometric Coefficient of Variation 244.9	0.2 Scores on a scale Geometric Coefficient of Variation 254.2	1.6 Scores on a scale Geometric Coefficient of Variation 87.9
Total Symptom Score Relative Day 5 Assessment 3	0.1 Scores on a scale Geometric Coefficient of Variation 364.8	0.4 Scores on a scale Geometric Coefficient of Variation 162.0	1.3 Scores on a scale Geometric Coefficient of Variation 115.9	0.1 Scores on a scale Geometric Coefficient of Variation 280.3	0.1 Scores on a scale Geometric Coefficient of Variation 331.7	1.4 Scores on a scale Geometric Coefficient of Variation 89.6
Total Symptom Score Relative Day 6 Assessment 2	0.2 Scores on a scale Geometric Coefficient of Variation 288.7	0.4 Scores on a scale Geometric Coefficient of Variation 186.9	1.0 Scores on a scale Geometric Coefficient of Variation 112.8	0.1 Scores on a scale Geometric Coefficient of Variation 387.3	0.3 Scores on a scale Geometric Coefficient of Variation 185.4	1.2 Scores on a scale Geometric Coefficient of Variation 102.4
Total Symptom Score Relative Day 6 Assessment 3	0.2 Scores on a scale Geometric Coefficient of Variation 280.9	0.3 Scores on a scale Geometric Coefficient of Variation 184.6	1.0 Scores on a scale Geometric Coefficient of Variation 100.5	0.1 Scores on a scale Geometric Coefficient of Variation 387.3	0.1 Scores on a scale Geometric Coefficient of Variation 210.8	1.1 Scores on a scale Geometric Coefficient of Variation 116.5
Total Symptom Score Relative Day 8 Assessment 1	0.1 Scores on a scale Geometric Coefficient of Variation 291.0	0.2 Scores on a scale Geometric Coefficient of Variation 199.9	0.9 Scores on a scale Geometric Coefficient of Variation 94.9	0.1 Scores on a scale Geometric Coefficient of Variation 331.7	0.0 Scores on a scale Geometric Coefficient of Variation NA %CV not calculable as Geometric Mean = 0.0	0.5 Scores on a scale Geometric Coefficient of Variation 153.7
Total Symptom Score Relative Day 2 Assessment 1	0.9 Scores on a scale Geometric Coefficient of Variation 97.5	0.8 Scores on a scale Geometric Coefficient of Variation 155.4	1.9 Scores on a scale Geometric Coefficient of Variation 117.0	0.5 Scores on a scale Geometric Coefficient of Variation 140.8	0.3 Scores on a scale Geometric Coefficient of Variation 222.5	3.0 Scores on a scale Geometric Coefficient of Variation 66.6
Total Symptom Score Relative Day 2 Assessment 2	0.8 Scores on a scale Geometric Coefficient of Variation 94.0	0.7 Scores on a scale Geometric Coefficient of Variation 160.3	2.4 Scores on a scale Geometric Coefficient of Variation 110.3	0.4 Scores on a scale Geometric Coefficient of Variation 185.2	0.5 Scores on a scale Geometric Coefficient of Variation 179.8	2.9 Scores on a scale Geometric Coefficient of Variation 82.5
Total Symptom Score Relative Day 2 Assessment 3	0.5 Scores on a scale Geometric Coefficient of Variation 117.0	0.6 Scores on a scale Geometric Coefficient of Variation 184.4	2.7 Scores on a scale Geometric Coefficient of Variation 94.9	0.3 Scores on a scale Geometric Coefficient of Variation 196.2	0.2 Scores on a scale Geometric Coefficient of Variation 331.7	2.6 Scores on a scale Geometric Coefficient of Variation 94.3
Total Symptom Score Relative Day 3 Assessment 1	0.4 Scores on a scale Geometric Coefficient of Variation 137.3	0.7 Scores on a scale Geometric Coefficient of Variation 148.5	2.6 Scores on a scale Geometric Coefficient of Variation 99.1	0.4 Scores on a scale Geometric Coefficient of Variation 166.9	0.2 Scores on a scale Geometric Coefficient of Variation 254.2	2.2 Scores on a scale Geometric Coefficient of Variation 103.0
Total Symptom Score Relative Day 3 Assessment 3	0.3 Scores on a scale Geometric Coefficient of Variation 190.9	0.6 Scores on a scale Geometric Coefficient of Variation 167.7	2.5 Scores on a scale Geometric Coefficient of Variation 103.7	0.2 Scores on a scale Geometric Coefficient of Variation 332.6	0.3 Scores on a scale Geometric Coefficient of Variation 276.4	2.2 Scores on a scale Geometric Coefficient of Variation 95.3
Total Symptom Score Relative Day 4 Assessment 2	0.3 Scores on a scale Geometric Coefficient of Variation 186.5	0.6 Scores on a scale Geometric Coefficient of Variation 163.1	1.8 Scores on a scale Geometric Coefficient of Variation 115.3	0.1 Scores on a scale Geometric Coefficient of Variation 387.3	0.1 Scores on a scale Geometric Coefficient of Variation 331.7	1.7 Scores on a scale Geometric Coefficient of Variation 85.0
Total Symptom Score Relative Day 4 Assessment 3	0.3 Scores on a scale Geometric Coefficient of Variation 263.0	0.4 Scores on a scale Geometric Coefficient of Variation 163.5	1.8 Scores on a scale Geometric Coefficient of Variation 103.1	0.2 Scores on a scale Geometric Coefficient of Variation 280.3	0.1 Scores on a scale Geometric Coefficient of Variation 331.7	1.8 Scores on a scale Geometric Coefficient of Variation 88.3
Total Symptom Score Relative Day 5 Assessment 2	0.3 Scores on a scale Geometric Coefficient of Variation 191.3	0.4 Scores on a scale Geometric Coefficient of Variation 177.1	1.4 Scores on a scale Geometric Coefficient of Variation 109.2	0.2 Scores on a scale Geometric Coefficient of Variation 314.0	0.2 Scores on a scale Geometric Coefficient of Variation 254.2	1.4 Scores on a scale Geometric Coefficient of Variation 112.8
Total Symptom Score Relative Day 6 Assessment 1	0.2 Scores on a scale Geometric Coefficient of Variation 300.9	0.4 Scores on a scale Geometric Coefficient of Variation 186.9	1.2 Scores on a scale Geometric Coefficient of Variation 106.0	0.2 Scores on a scale Geometric Coefficient of Variation 314.0	0.2 Scores on a scale Geometric Coefficient of Variation 237.1	1.5 Scores on a scale Geometric Coefficient of Variation 83.3
Total Symptom Score Relative Day 7 Assessment 1	0.2 Scores on a scale Geometric Coefficient of Variation 225.1	0.2 Scores on a scale Geometric Coefficient of Variation 205.3	0.7 Scores on a scale Geometric Coefficient of Variation 124.9	0.1 Scores on a scale Geometric Coefficient of Variation 387.3	0.1 Scores on a scale Geometric Coefficient of Variation 316.2	0.8 Scores on a scale Geometric Coefficient of Variation 126.1
Total Symptom Score Relative Day 7 Assessment 2	0.2 Scores on a scale Geometric Coefficient of Variation 196.2	0.2 Scores on a scale Geometric Coefficient of Variation 162.0	0.7 Scores on a scale Geometric Coefficient of Variation 115.7	0.1 Scores on a scale Geometric Coefficient of Variation 346.4	0.1 Scores on a scale Geometric Coefficient of Variation 300.0	0.9 Scores on a scale Geometric Coefficient of Variation 153.5
Total Symptom Score Relative Day 7 Assessment 3	0.2 Scores on a scale Geometric Coefficient of Variation 291.0	0.2 Scores on a scale Geometric Coefficient of Variation 185.8	0.9 Scores on a scale Geometric Coefficient of Variation 89.9	0.1 Scores on a scale Geometric Coefficient of Variation 331.7	0.0 Scores on a scale Geometric Coefficient of Variation NA %CV not calculable as Geometric Mean = 0.0	0.7 Scores on a scale Geometric Coefficient of Variation 179.2
Total Symptom Score Relative Day 8 Assessment 2	0.1 Scores on a scale Geometric Coefficient of Variation 374.2	0.1 Scores on a scale Geometric Coefficient of Variation 244.1	0.9 Scores on a scale Geometric Coefficient of Variation 99.4	0.2 Scores on a scale Geometric Coefficient of Variation 264.6	0.0 Scores on a scale Geometric Coefficient of Variation NA %CV not calculable as Geometric Mean = 0.0	0.2 Scores on a scale Geometric Coefficient of Variation 170.8
Total Symptom Score Relative Day 8 Assessment 3	0.0 Scores on a scale Geometric Coefficient of Variation NA %CV not calculable as Geometric Mean = 0.0	0.4 Scores on a scale Geometric Coefficient of Variation 149.1	0.6 Scores on a scale Geometric Coefficient of Variation 129.1	0.0 Scores on a scale Geometric Coefficient of Variation NA %CV not calculable as Geometric Mean = 0.0	—	0.2 Scores on a scale Geometric Coefficient of Variation 200.0
Total Symptom Score Relative Day 9 Assessment 1	0.0 Scores on a scale Geometric Coefficient of Variation NA %CV not calculable as Geometric Mean = 0.0	0.0 Scores on a scale Geometric Coefficient of Variation NA %CV not calculable as Geometric Mean = 0.0	0.4 Scores on a scale Geometric Coefficient of Variation 140.5	0.0 Scores on a scale Geometric Coefficient of Variation NA %CV not calculable as Geometric Mean = 0.0	—	0.2 Scores on a scale Geometric Coefficient of Variation 200.0
Total Symptom Score Relative Day 9 Assessment 2	0.0 Scores on a scale Geometric Coefficient of Variation NA %CV not calculable as Geometric Mean = 0.0	0.0 Scores on a scale Geometric Coefficient of Variation NA %CV not calculable as Geometric Mean = 0.0	0.5 Scores on a scale Geometric Coefficient of Variation 91.3	0.0 Scores on a scale Geometric Coefficient of Variation NA %CV not calculable as Geometric Mean = 0.0	—	0.4 Scores on a scale Geometric Coefficient of Variation 141.4

SECONDARY outcome

Timeframe: Day 2 to Day 12

Time to peak total symptom score was defined as the time in days to the highest total symptom score between first dose of study drug and Day 12. Total symptom scores at the time of the first dose of study drug can be before or after dosing.

Outcome measures

Outcome measures
Measure	Part 1: EDP-938 600 mg n=25 Participants Participants were administered EDP-938 oral suspension of 600 mg followed after 12 hours by a placebo once daily (OD) for a total of 10 doses over 5 days.	Part 1: EDP-938 500 mg Then 300 mg n=31 Participants Participants were administered EDP-938 oral suspension as a single loading dose of 500 mg followed after 12 hours by EDP-938 300 mg twice daily (BID) (every 12 hours) for a total of 10 doses over 5 days.	Part 1: Placebo n=30 Participants Participants were administered a placebo BID (every 12 hours) for a total of 10 doses over 5 days.	Part 2: EDP-938 600 mg Then 300 mg n=15 Participants Participants were administered a single loading dose of 600 mg EDP-938, followed by EDP-938 300 mg OD, and with dosing for 5 days.	Part 2: EDP-938 400 mg Then 200 mg n=11 Participants Participants were administered a single loading dose of 400 mg EDP-938 followed by EDP-938 200 mg at 12 hours, then EDP-938 200 mg BID, and with dosing for 5 days.	Part 2: Placebo n=12 Participants Participants were administered a placebo BID for 5 days, with dosing at 12 hour intervals.
Time to Peak Total Symptom Score	1.18 Days Geometric Coefficient of Variation 137.8	1.76 Days Geometric Coefficient of Variation 110.0	2.15 Days Geometric Coefficient of Variation 71.4	1.45 Days Geometric Coefficient of Variation 131.9	1.09 Days Geometric Coefficient of Variation 136.4	1.94 Days Geometric Coefficient of Variation 80.5

SECONDARY outcome

Timeframe: Day 2 to Day 12

Population: Intent to Treat Infected (ITT-I) Analysis Set, defined as all randomised participants who received challenge virus and at least one dose of investigational medicinal product (IMP), and who met the criterion for laboratory confirmed respiratory syncytial virus (RSV) infection as per the definition of laboratory confirmed infection. 9 participants in Part 1 and 5 participants in Part 2 were excluded from the analysis due to having no symptoms in the interval first dose of study drug to Day 12.

Time to resolution from peak total symptom score was defined as the time in days from the highest total symptom score (between first dose of study drug and Day 12) until the start of the first 24-hour symptom-free period (after the highest total symptom score). Total symptom scores at the time of the first dose of study drug can be before or after dosing.

Outcome measures

Outcome measures
Measure	Part 1: EDP-938 600 mg n=23 Participants Participants were administered EDP-938 oral suspension of 600 mg followed after 12 hours by a placebo once daily (OD) for a total of 10 doses over 5 days.	Part 1: EDP-938 500 mg Then 300 mg n=24 Participants Participants were administered EDP-938 oral suspension as a single loading dose of 500 mg followed after 12 hours by EDP-938 300 mg twice daily (BID) (every 12 hours) for a total of 10 doses over 5 days.	Part 1: Placebo n=30 Participants Participants were administered a placebo BID (every 12 hours) for a total of 10 doses over 5 days.	Part 2: EDP-938 600 mg Then 300 mg n=12 Participants Participants were administered a single loading dose of 600 mg EDP-938, followed by EDP-938 300 mg OD, and with dosing for 5 days.	Part 2: EDP-938 400 mg Then 200 mg n=10 Participants Participants were administered a single loading dose of 400 mg EDP-938 followed by EDP-938 200 mg at 12 hours, then EDP-938 200 mg BID, and with dosing for 5 days.	Part 2: Placebo n=11 Participants Participants were administered a placebo BID for 5 days, with dosing at 12 hour intervals.
Time to Resolution From Peak Total Symptom Score	2.49 Days Geometric Coefficient of Variation 70.1	2.83 Days Geometric Coefficient of Variation 77.5	3.30 Days Geometric Coefficient of Variation 61.7	2.19 Days Geometric Coefficient of Variation 70.0	1.38 Days Geometric Coefficient of Variation 116.5	5.17 Days Geometric Coefficient of Variation 383

SECONDARY outcome

Timeframe: Day 2 to Day 12

Measured via weighed paper tissues and reported as a mean total across all study days.

Outcome measures

Outcome measures
Measure	Part 1: EDP-938 600 mg n=25 Participants Participants were administered EDP-938 oral suspension of 600 mg followed after 12 hours by a placebo once daily (OD) for a total of 10 doses over 5 days.	Part 1: EDP-938 500 mg Then 300 mg n=31 Participants Participants were administered EDP-938 oral suspension as a single loading dose of 500 mg followed after 12 hours by EDP-938 300 mg twice daily (BID) (every 12 hours) for a total of 10 doses over 5 days.	Part 1: Placebo n=30 Participants Participants were administered a placebo BID (every 12 hours) for a total of 10 doses over 5 days.	Part 2: EDP-938 600 mg Then 300 mg n=15 Participants Participants were administered a single loading dose of 600 mg EDP-938, followed by EDP-938 300 mg OD, and with dosing for 5 days.	Part 2: EDP-938 400 mg Then 200 mg n=11 Participants Participants were administered a single loading dose of 400 mg EDP-938 followed by EDP-938 200 mg at 12 hours, then EDP-938 200 mg BID, and with dosing for 5 days.	Part 2: Placebo n=12 Participants Participants were administered a placebo BID for 5 days, with dosing at 12 hour intervals.
Total Weight of Nasal Mucus Produced	12.965 Grams Standard Deviation 13.0314	7.428 Grams Standard Deviation 11.1324	33.416 Grams Standard Deviation 37.8072	2.983 Grams Standard Deviation 4.4226	4.716 Grams Standard Deviation 6.0015	22.391 Grams Standard Deviation 20.6005

SECONDARY outcome

Timeframe: Day 2 to Day 12

Peak viral load was defined as the highest quantitative reverse transcription polymerase chain reaction (RT-qPCR) viral load value between first dose of study drug and Day 12. Measured by nasal wash RT-qPCR.

Outcome measures

Outcome measures
Measure	Part 1: EDP-938 600 mg n=25 Participants Participants were administered EDP-938 oral suspension of 600 mg followed after 12 hours by a placebo once daily (OD) for a total of 10 doses over 5 days.	Part 1: EDP-938 500 mg Then 300 mg n=31 Participants Participants were administered EDP-938 oral suspension as a single loading dose of 500 mg followed after 12 hours by EDP-938 300 mg twice daily (BID) (every 12 hours) for a total of 10 doses over 5 days.	Part 1: Placebo n=30 Participants Participants were administered a placebo BID (every 12 hours) for a total of 10 doses over 5 days.	Part 2: EDP-938 600 mg Then 300 mg n=15 Participants Participants were administered a single loading dose of 600 mg EDP-938, followed by EDP-938 300 mg OD, and with dosing for 5 days.	Part 2: EDP-938 400 mg Then 200 mg n=11 Participants Participants were administered a single loading dose of 400 mg EDP-938 followed by EDP-938 200 mg at 12 hours, then EDP-938 200 mg BID, and with dosing for 5 days.	Part 2: Placebo n=12 Participants Participants were administered a placebo BID for 5 days, with dosing at 12 hour intervals.
Peak Viral Load	4.3552 log10 copies/milliliter (mL) Standard Deviation 1.56334	4.3111 log10 copies/milliliter (mL) Standard Deviation 1.76974	6.4727 log10 copies/milliliter (mL) Standard Deviation 1.60659	3.9718 log10 copies/milliliter (mL) Standard Deviation 1.78873	4.7727 log10 copies/milliliter (mL) Standard Deviation 1.35014	7.0973 log10 copies/milliliter (mL) Standard Deviation 1.24388

SECONDARY outcome

Timeframe: Day 2 to Day 12

Time to peak viral load was defined as the time to the highest quantitative reverse transcription polymerase chain reaction (RT-qPCR) viral load value between first dose of study drug and Day 12. Measured by nasal wash RT-qPCR.

Outcome measures

Outcome measures
Measure	Part 1: EDP-938 600 mg n=25 Participants Participants were administered EDP-938 oral suspension of 600 mg followed after 12 hours by a placebo once daily (OD) for a total of 10 doses over 5 days.	Part 1: EDP-938 500 mg Then 300 mg n=31 Participants Participants were administered EDP-938 oral suspension as a single loading dose of 500 mg followed after 12 hours by EDP-938 300 mg twice daily (BID) (every 12 hours) for a total of 10 doses over 5 days.	Part 1: Placebo n=30 Participants Participants were administered a placebo BID (every 12 hours) for a total of 10 doses over 5 days.	Part 2: EDP-938 600 mg Then 300 mg n=15 Participants Participants were administered a single loading dose of 600 mg EDP-938, followed by EDP-938 300 mg OD, and with dosing for 5 days.	Part 2: EDP-938 400 mg Then 200 mg n=11 Participants Participants were administered a single loading dose of 400 mg EDP-938 followed by EDP-938 200 mg at 12 hours, then EDP-938 200 mg BID, and with dosing for 5 days.	Part 2: Placebo n=12 Participants Participants were administered a placebo BID for 5 days, with dosing at 12 hour intervals.
Time to Peak Viral Load	0.74 Days Geometric Coefficient of Variation 75.6	0.80 Days Geometric Coefficient of Variation 130.2	2.59 Days Geometric Coefficient of Variation 48.5	0.88 Days Geometric Coefficient of Variation 181.3	0.79 Days Geometric Coefficient of Variation 64.0	3.43 Days Geometric Coefficient of Variation 33.7

SECONDARY outcome

Timeframe: Day 2 to Day 12

Population: Intent to Treat Infected (ITT-I) Analysis Set, defined as all randomised participants who received challenge virus and at least one dose of investigational medicinal product (IMP), and who met the criterion for laboratory confirmed respiratory syncytial virus (RSV) infection as per the definition of laboratory confirmed infection. Participants were excluded from the analysis if it was concluded that the criteria for laboratory-confirmed RSV infection were not met.

Time to resolution from peak viral load was defined as the time from peak until first confirmed undetectable assessment between first dose of study drug and Day 12. Measured by by nasal wash quantitative reverse transcription polymerase chain reaction (RT-qPCR).

Outcome measures

Outcome measures
Measure	Part 1: EDP-938 600 mg n=25 Participants Participants were administered EDP-938 oral suspension of 600 mg followed after 12 hours by a placebo once daily (OD) for a total of 10 doses over 5 days.	Part 1: EDP-938 500 mg Then 300 mg n=30 Participants Participants were administered EDP-938 oral suspension as a single loading dose of 500 mg followed after 12 hours by EDP-938 300 mg twice daily (BID) (every 12 hours) for a total of 10 doses over 5 days.	Part 1: Placebo n=30 Participants Participants were administered a placebo BID (every 12 hours) for a total of 10 doses over 5 days.	Part 2: EDP-938 600 mg Then 300 mg n=14 Participants Participants were administered a single loading dose of 600 mg EDP-938, followed by EDP-938 300 mg OD, and with dosing for 5 days.	Part 2: EDP-938 400 mg Then 200 mg n=11 Participants Participants were administered a single loading dose of 400 mg EDP-938 followed by EDP-938 200 mg at 12 hours, then EDP-938 200 mg BID, and with dosing for 5 days.	Part 2: Placebo n=12 Participants Participants were administered a placebo BID for 5 days, with dosing at 12 hour intervals.
Time to Resolution From Peak Viral Load	2.03 Days Geometric Coefficient of Variation 72.1	2.02 Days Geometric Coefficient of Variation 79.7	4.03 Days Geometric Coefficient of Variation 47.5	1.67 Days Geometric Coefficient of Variation 77.1	1.63 Days Geometric Coefficient of Variation 43.7	3.58 Days Geometric Coefficient of Variation 45.6

SECONDARY outcome

Timeframe: Day 2 to Day 12

Population: Intent to Treat Infected (ITT-I) Analysis Set, defined as all randomised participants who received challenge virus and at least one dose of investigational medicinal product (IMP), and who met the criterion for laboratory confirmed respiratory syncytial virus (RSV) infection as per the definition of laboratory confirmed infection. Participants were excluded from the analysis if it was concluded that the criteria for laboratory-confirmed RSV infection were not met.

Time to cessation of virus detection was measured by nasal wash quantitative reverse transcription polymerase chain reaction (RT-qPCR).

Outcome measures

Outcome measures
Measure	Part 1: EDP-938 600 mg n=25 Participants Participants were administered EDP-938 oral suspension of 600 mg followed after 12 hours by a placebo once daily (OD) for a total of 10 doses over 5 days.	Part 1: EDP-938 500 mg Then 300 mg n=30 Participants Participants were administered EDP-938 oral suspension as a single loading dose of 500 mg followed after 12 hours by EDP-938 300 mg twice daily (BID) (every 12 hours) for a total of 10 doses over 5 days.	Part 1: Placebo n=30 Participants Participants were administered a placebo BID (every 12 hours) for a total of 10 doses over 5 days.	Part 2: EDP-938 600 mg Then 300 mg n=14 Participants Participants were administered a single loading dose of 600 mg EDP-938, followed by EDP-938 300 mg OD, and with dosing for 5 days.	Part 2: EDP-938 400 mg Then 200 mg n=11 Participants Participants were administered a single loading dose of 400 mg EDP-938 followed by EDP-938 200 mg at 12 hours, then EDP-938 200 mg BID, and with dosing for 5 days.	Part 2: Placebo n=12 Participants Participants were administered a placebo BID for 5 days, with dosing at 12 hour intervals.
Time to Cessation of Virus Detection	3.5 Days Interval 2.0 to 4.5	3.2 Days Interval 1.5 to 4.5	8.5 Days Interval 6.5 to Upper quartile is non-estimable as there were too many censored values in the placebo group. If a participant did not have a confirmed undetectable assessment after their peak, the time to cessation was censored (at the last detectable RT-qPCR result).	2.7 Days Interval 1.5 to 4.0	2.5 Days Interval 1.5 to 3.5	8.5 Days Interval 7.0 to 9.0

SECONDARY outcome

Timeframe: Day 2 to Day 28

Population: Safety Analysis Set, defined as all participants who received challenge virus, whether they received study drug or not. One inoculated participant was not randomized to a specific treatment assignment and is not included in this analysis.

A TEAE was defined as any untoward medical occurrence in participants that happened after study drug administration. Any clinically significant physical examinations, vital signs, clinical laboratory tests (including biochemistry, hematology, coagulation \[if required\], cardiac enzymes and urine analysis), 12-lead electrocardiograms (ECGs) and spirometry results were recorded as adverse events.

Outcome measures

Outcome measures
Measure	Part 1: EDP-938 600 mg n=38 Participants Participants were administered EDP-938 oral suspension of 600 mg followed after 12 hours by a placebo once daily (OD) for a total of 10 doses over 5 days.	Part 1: EDP-938 500 mg Then 300 mg n=38 Participants Participants were administered EDP-938 oral suspension as a single loading dose of 500 mg followed after 12 hours by EDP-938 300 mg twice daily (BID) (every 12 hours) for a total of 10 doses over 5 days.	Part 1: Placebo n=38 Participants Participants were administered a placebo BID (every 12 hours) for a total of 10 doses over 5 days.	Part 2: EDP-938 600 mg Then 300 mg n=21 Participants Participants were administered a single loading dose of 600 mg EDP-938, followed by EDP-938 300 mg OD, and with dosing for 5 days.	Part 2: EDP-938 400 mg Then 200 mg n=21 Participants Participants were administered a single loading dose of 400 mg EDP-938 followed by EDP-938 200 mg at 12 hours, then EDP-938 200 mg BID, and with dosing for 5 days.	Part 2: Placebo n=21 Participants Participants were administered a placebo BID for 5 days, with dosing at 12 hour intervals.
Safety and Tolerability as Assessed by Number of Participants With Treatment-emergent Adverse Events (TEAEs)	20 Participants	21 Participants	21 Participants	8 Participants	10 Participants	11 Participants

SECONDARY outcome

Timeframe: Day 2: pre-dose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post-dose; and Day 7: 15, 24, 30, 36, 48, 60, and 72 hours post-dose

The metabolites of EDP-938 that were assessed were EP-024636, EP-024594 and EP-024595.

Outcome measures

Outcome measures
Measure	Part 1: EDP-938 600 mg n=38 Participants Participants were administered EDP-938 oral suspension of 600 mg followed after 12 hours by a placebo once daily (OD) for a total of 10 doses over 5 days.	Part 1: EDP-938 500 mg Then 300 mg n=37 Participants Participants were administered EDP-938 oral suspension as a single loading dose of 500 mg followed after 12 hours by EDP-938 300 mg twice daily (BID) (every 12 hours) for a total of 10 doses over 5 days.	Part 1: Placebo n=21 Participants Participants were administered a placebo BID (every 12 hours) for a total of 10 doses over 5 days.	Part 2: EDP-938 600 mg Then 300 mg n=20 Participants Participants were administered a single loading dose of 600 mg EDP-938, followed by EDP-938 300 mg OD, and with dosing for 5 days.	Part 2: EDP-938 400 mg Then 200 mg Participants were administered a single loading dose of 400 mg EDP-938 followed by EDP-938 200 mg at 12 hours, then EDP-938 200 mg BID, and with dosing for 5 days.	Part 2: Placebo Participants were administered a placebo BID for 5 days, with dosing at 12 hour intervals.
Maximum Plasma Concentration (Cmax) of EDP-938 and Its Metabolites EDP-938 First Dose	1370 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 49.7	1151 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 46.9	1237.91 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 33.2	800.73 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 44.9	—	—
Maximum Plasma Concentration (Cmax) of EDP-938 and Its Metabolites EDP-938 Last Dose	1740 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 52.8	1480 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 33.4	1010 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 15.9	901 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 27.9	—	—
Maximum Plasma Concentration (Cmax) of EDP-938 and Its Metabolites EP-024636 First Dose	256 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 39.3	215 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 41.3	264 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 42.0	177 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 48.2	—	—
Maximum Plasma Concentration (Cmax) of EDP-938 and Its Metabolites EP-024636 Last Dose	361 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 34.8	342 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 27.8	230 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 23.0	232 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 32.0	—	—
Maximum Plasma Concentration (Cmax) of EDP-938 and Its Metabolites EP-024594 First Dose	96.3 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 48.1	76.8 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 54.8	102 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 61.1	72.3 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 49.1	—	—
Maximum Plasma Concentration (Cmax) of EDP-938 and Its Metabolites EP-024594 Last Dose	203 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 32.6	240 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 30.1	130 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 44.1	168 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 32.9	—	—
Maximum Plasma Concentration (Cmax) of EDP-938 and Its Metabolites EP-024595 First Dose	150 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 63.2	102 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 79.6	167 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 81.1	100 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 72.1	—	—
Maximum Plasma Concentration (Cmax) of EDP-938 and Its Metabolites EP-024595 Last Dose	717 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 45.6	1000 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 49.1	499 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 89.0	692 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 50.5	—	—

SECONDARY outcome

Timeframe: Day 2: pre-dose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post-dose; and Day 7: 15, 24, 30, 36, 48, 60, and 72 hours post-dose

The metabolites of EDP-938 that were assessed were EP-024636, EP-024594 and EP-024595.

Outcome measures

Outcome measures
Measure	Part 1: EDP-938 600 mg n=38 Participants Participants were administered EDP-938 oral suspension of 600 mg followed after 12 hours by a placebo once daily (OD) for a total of 10 doses over 5 days.	Part 1: EDP-938 500 mg Then 300 mg n=37 Participants Participants were administered EDP-938 oral suspension as a single loading dose of 500 mg followed after 12 hours by EDP-938 300 mg twice daily (BID) (every 12 hours) for a total of 10 doses over 5 days.	Part 1: Placebo n=21 Participants Participants were administered a placebo BID (every 12 hours) for a total of 10 doses over 5 days.	Part 2: EDP-938 600 mg Then 300 mg n=20 Participants Participants were administered a single loading dose of 600 mg EDP-938, followed by EDP-938 300 mg OD, and with dosing for 5 days.	Part 2: EDP-938 400 mg Then 200 mg Participants were administered a single loading dose of 400 mg EDP-938 followed by EDP-938 200 mg at 12 hours, then EDP-938 200 mg BID, and with dosing for 5 days.	Part 2: Placebo Participants were administered a placebo BID for 5 days, with dosing at 12 hour intervals.
Time to Maximum Plasma Concentration (Tmax) of EDP-938 and Its Metabolites EDP-938 First Dose	4.56 Hours Interval 2.0 to 10.0	5.00 Hours Interval 1.0 to 12.0	5.80 Hours Interval 1.9 to 10.2	6.07 Hours Interval 2.0 to 10.2	—	—
Time to Maximum Plasma Concentration (Tmax) of EDP-938 and Its Metabolites EDP-938 Last Dose	4.52 Hours Interval 1.9 to 17.0	4.10 Hours Interval 0.0 to 10.1	4.98 Hours Interval 1.0 to 15.9	4.04 Hours Interval 0.0 to 10.0	—	—
Time to Maximum Plasma Concentration (Tmax) of EDP-938 and Its Metabolites EP-024636 First Dose	5.91 Hours Interval 2.9 to 23.5	5.97 Hours Interval 2.0 to 12.0	7.97 Hours Interval 3.1 to 11.9	6.99 Hours Interval 2.0 to 11.8	—	—
Time to Maximum Plasma Concentration (Tmax) of EDP-938 and Its Metabolites EP-024636 Last Dose	5.00 Hours Interval 2.8 to 15.0	4.88 Hours Interval 0.5 to 8.0	6.00 Hours Interval 3.0 to 17.0	4.04 Hours Interval 0.0 to 8.3	—	—
Time to Maximum Plasma Concentration (Tmax) of EDP-938 and Its Metabolites EP-024594 First Dose	10.07 Hours Interval 4.1 to 24.1	10.23 Hours Interval 4.0 to 12.0	11.83 Hours Interval 6.2 to 23.8	10.14 Hours Interval 4.9 to 11.9	—	—
Time to Maximum Plasma Concentration (Tmax) of EDP-938 and Its Metabolites EP-024594 Last Dose	8.07 Hours Interval 4.0 to 20.1	4.98 Hours Interval 0.0 to 12.0	8.00 Hours Interval 0.5 to 17.2	5.03 Hours Interval 0.0 to 8.3	—	—
Time to Maximum Plasma Concentration (Tmax) of EDP-938 and Its Metabolites EP-024595 First Dose	23.72 Hours Interval 8.0 to 24.1	11.85 Hours Interval 8.0 to 12.2	23.75 Hours Interval 11.8 to 24.0	11.83 Hours Interval 5.8 to 12.0	—	—
Time to Maximum Plasma Concentration (Tmax) of EDP-938 and Its Metabolites EP-024595 Last Dose	10.90 Hours Interval 3.0 to 22.0	5.07 Hours Interval 0.4 to 12.0	11.88 Hours Interval 2.8 to 22.3	4.04 Hours Interval 0.0 to 9.9	—	—

SECONDARY outcome

Timeframe: Day 2 and Day 6: Pre-dose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose; Day 7 only: 15, 24, 30, 36, 48, 60, and 72 hours post-dose

The metabolites of EDP-938 that were assessed were EP-024636, EP-024594 and EP-024595.

Outcome measures

Outcome measures
Measure	Part 1: EDP-938 600 mg n=38 Participants Participants were administered EDP-938 oral suspension of 600 mg followed after 12 hours by a placebo once daily (OD) for a total of 10 doses over 5 days.	Part 1: EDP-938 500 mg Then 300 mg n=35 Participants Participants were administered EDP-938 oral suspension as a single loading dose of 500 mg followed after 12 hours by EDP-938 300 mg twice daily (BID) (every 12 hours) for a total of 10 doses over 5 days.	Part 1: Placebo n=21 Participants Participants were administered a placebo BID (every 12 hours) for a total of 10 doses over 5 days.	Part 2: EDP-938 600 mg Then 300 mg n=20 Participants Participants were administered a single loading dose of 600 mg EDP-938, followed by EDP-938 300 mg OD, and with dosing for 5 days.	Part 2: EDP-938 400 mg Then 200 mg Participants were administered a single loading dose of 400 mg EDP-938 followed by EDP-938 200 mg at 12 hours, then EDP-938 200 mg BID, and with dosing for 5 days.	Part 2: Placebo Participants were administered a placebo BID for 5 days, with dosing at 12 hour intervals.
Terminal Phase Half-Life (t1/2) of EDP-938 and Its Metabolites EDP-938	14.5 Hours Geometric Coefficient of Variation 25.4	13.8 Hours Geometric Coefficient of Variation 27.4	14.5 Hours Geometric Coefficient of Variation 31.3	13.7 Hours Geometric Coefficient of Variation 23.5	—	—
Terminal Phase Half-Life (t1/2) of EDP-938 and Its Metabolites EP-024636	14.5 Hours Geometric Coefficient of Variation 21.5	13.4 Hours Geometric Coefficient of Variation 21.1	14.4 Hours Geometric Coefficient of Variation 29.8	13.5 Hours Geometric Coefficient of Variation 21.2	—	—
Terminal Phase Half-Life (t1/2) of EDP-938 and Its Metabolites EP-024594	17.8 Hours Geometric Coefficient of Variation 18.2	16.2 Hours Geometric Coefficient of Variation 18.5	17.5 Hours Geometric Coefficient of Variation 25.1	15.4 Hours Geometric Coefficient of Variation 17.0	—	—
Terminal Phase Half-Life (t1/2) of EDP-938 and Its Metabolites EP-024595	28.5 Hours Geometric Coefficient of Variation 38.2	25.5 Hours Geometric Coefficient of Variation 25.1	22.7 Hours Geometric Coefficient of Variation 15.6	23.0 Hours Geometric Coefficient of Variation 19.4	—	—

SECONDARY outcome

Timeframe: Day 2 and Day 6: Pre-dose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose; Day 7 only: 15, 24, 30, 36, 48, 60, and 72 hours post-dose

Outcome measures

Outcome measures
Measure	Part 1: EDP-938 600 mg n=38 Participants Participants were administered EDP-938 oral suspension of 600 mg followed after 12 hours by a placebo once daily (OD) for a total of 10 doses over 5 days.	Part 1: EDP-938 500 mg Then 300 mg n=35 Participants Participants were administered EDP-938 oral suspension as a single loading dose of 500 mg followed after 12 hours by EDP-938 300 mg twice daily (BID) (every 12 hours) for a total of 10 doses over 5 days.	Part 1: Placebo n=21 Participants Participants were administered a placebo BID (every 12 hours) for a total of 10 doses over 5 days.	Part 2: EDP-938 600 mg Then 300 mg n=20 Participants Participants were administered a single loading dose of 600 mg EDP-938, followed by EDP-938 300 mg OD, and with dosing for 5 days.	Part 2: EDP-938 400 mg Then 200 mg Participants were administered a single loading dose of 400 mg EDP-938 followed by EDP-938 200 mg at 12 hours, then EDP-938 200 mg BID, and with dosing for 5 days.	Part 2: Placebo Participants were administered a placebo BID for 5 days, with dosing at 12 hour intervals.
Apparent Systemic Clearance at Steady State (CLss/F) of EDP-938	26.9 litres per hour Geometric Coefficient of Variation 44.8	24.1 litres per hour Geometric Coefficient of Variation 28.4	21.3 litres per hour Geometric Coefficient of Variation 17.6	25.0 litres per hour Geometric Coefficient of Variation 23.9	—	—

SECONDARY outcome

Timeframe: Day 2 and Day 6: Pre-dose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose; Day 7 only: 15, 24, 30, 36, 48, 60, and 72 hours post-dose

The metabolites of EDP-938 that were assessed were EP-024636, EP-024594 and EP-024595.

Outcome measures

Outcome measures
Measure	Part 1: EDP-938 600 mg n=38 Participants Participants were administered EDP-938 oral suspension of 600 mg followed after 12 hours by a placebo once daily (OD) for a total of 10 doses over 5 days.	Part 1: EDP-938 500 mg Then 300 mg n=35 Participants Participants were administered EDP-938 oral suspension as a single loading dose of 500 mg followed after 12 hours by EDP-938 300 mg twice daily (BID) (every 12 hours) for a total of 10 doses over 5 days.	Part 1: Placebo n=21 Participants Participants were administered a placebo BID (every 12 hours) for a total of 10 doses over 5 days.	Part 2: EDP-938 600 mg Then 300 mg n=20 Participants Participants were administered a single loading dose of 600 mg EDP-938, followed by EDP-938 300 mg OD, and with dosing for 5 days.	Part 2: EDP-938 400 mg Then 200 mg Participants were administered a single loading dose of 400 mg EDP-938 followed by EDP-938 200 mg at 12 hours, then EDP-938 200 mg BID, and with dosing for 5 days.	Part 2: Placebo Participants were administered a placebo BID for 5 days, with dosing at 12 hour intervals.
Terminal Phase Rate Constant Calculated by Linear Regression of the Terminal Loglinear Portion of the Concentration vs. Time Curve (λz) of EDP-938 and Its Metabolites EDP-938	0.05 1/hour Geometric Coefficient of Variation 1.2	0.05 1/hour Geometric Coefficient of Variation 1.6	0.05 1/hour Geometric Coefficient of Variation 1.5	0.05 1/hour Geometric Coefficient of Variation 1.2	—	—
Terminal Phase Rate Constant Calculated by Linear Regression of the Terminal Loglinear Portion of the Concentration vs. Time Curve (λz) of EDP-938 and Its Metabolites EP-024636	0.05 1/hour Geometric Coefficient of Variation 1.1	0.05 1/hour Geometric Coefficient of Variation 1.2	0.05 1/hour Geometric Coefficient of Variation 1.3	0.05 1/hour Geometric Coefficient of Variation 1.1	—	—
Terminal Phase Rate Constant Calculated by Linear Regression of the Terminal Loglinear Portion of the Concentration vs. Time Curve (λz) of EDP-938 and Its Metabolites EP-024594	0.04 1/hour Geometric Coefficient of Variation 0.7	0.04 1/hour Geometric Coefficient of Variation 0.8	0.04 1/hour Geometric Coefficient of Variation 1.0	0.05 1/hour Geometric Coefficient of Variation 0.8	—	—
Terminal Phase Rate Constant Calculated by Linear Regression of the Terminal Loglinear Portion of the Concentration vs. Time Curve (λz) of EDP-938 and Its Metabolites EP-024595	0.03 1/hour Geometric Coefficient of Variation 1.3	0.03 1/hour Geometric Coefficient of Variation 0.9	0.03 1/hour Geometric Coefficient of Variation 0.5	0.03 1/hour Geometric Coefficient of Variation 0.6	—	—

SECONDARY outcome

Timeframe: Day 2 and Day 6: Pre-dose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose; Day 7 only: 15, 24, 30, 36, 48, 60, and 72 hours post-dose

Outcome measures

Outcome measures
Measure	Part 1: EDP-938 600 mg n=38 Participants Participants were administered EDP-938 oral suspension of 600 mg followed after 12 hours by a placebo once daily (OD) for a total of 10 doses over 5 days.	Part 1: EDP-938 500 mg Then 300 mg n=35 Participants Participants were administered EDP-938 oral suspension as a single loading dose of 500 mg followed after 12 hours by EDP-938 300 mg twice daily (BID) (every 12 hours) for a total of 10 doses over 5 days.	Part 1: Placebo n=21 Participants Participants were administered a placebo BID (every 12 hours) for a total of 10 doses over 5 days.	Part 2: EDP-938 600 mg Then 300 mg n=20 Participants Participants were administered a single loading dose of 600 mg EDP-938, followed by EDP-938 300 mg OD, and with dosing for 5 days.	Part 2: EDP-938 400 mg Then 200 mg Participants were administered a single loading dose of 400 mg EDP-938 followed by EDP-938 200 mg at 12 hours, then EDP-938 200 mg BID, and with dosing for 5 days.	Part 2: Placebo Participants were administered a placebo BID for 5 days, with dosing at 12 hour intervals.
Volume of Distribution at Steady State (Vss/F) of EDP-938	560 litre(s) Geometric Coefficient of Variation 42.8	476 litre(s) Geometric Coefficient of Variation 23.1	442 litre(s) Geometric Coefficient of Variation 24.1	491 litre(s) Geometric Coefficient of Variation 28.8	—	—

SECONDARY outcome

Timeframe: Day 2 and Day 7; 12 hours post-dose

Population: Pharmacokinetic (PK) Analysis Set, defined as all Intent to Treat (ITT) participants with at least one post-dose PK result. Participants were excluded from the analysis if plasma concentrations were below the limit of quantification. C12 is only reported for twice daily (BID) dosing groups relative to the last dose. Data were specifically collected for BID dosing groups at the specified times.

The metabolites of EDP-938 that were assessed were EP-024636, EP-024594 and EP-024595.

Outcome measures

Outcome measures
Measure	Part 1: EDP-938 600 mg Participants were administered EDP-938 oral suspension of 600 mg followed after 12 hours by a placebo once daily (OD) for a total of 10 doses over 5 days.	Part 1: EDP-938 500 mg Then 300 mg n=37 Participants Participants were administered EDP-938 oral suspension as a single loading dose of 500 mg followed after 12 hours by EDP-938 300 mg twice daily (BID) (every 12 hours) for a total of 10 doses over 5 days.	Part 1: Placebo Participants were administered a placebo BID (every 12 hours) for a total of 10 doses over 5 days.	Part 2: EDP-938 600 mg Then 300 mg n=20 Participants Participants were administered a single loading dose of 600 mg EDP-938, followed by EDP-938 300 mg OD, and with dosing for 5 days.	Part 2: EDP-938 400 mg Then 200 mg Participants were administered a single loading dose of 400 mg EDP-938 followed by EDP-938 200 mg at 12 hours, then EDP-938 200 mg BID, and with dosing for 5 days.	Part 2: Placebo Participants were administered a placebo BID for 5 days, with dosing at 12 hour intervals.
Plasma Concentration at 12 Hours (C12) of EDP-938 and Its Metabolites EP-024636 First Dose	—	168 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 32.1	—	149 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 41.0	—	—
Plasma Concentration at 12 Hours (C12) of EDP-938 and Its Metabolites EDP-938 First Dose	—	679.35 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 34.5	—	565.60 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 39.5	—	—
Plasma Concentration at 12 Hours (C12) of EDP-938 and Its Metabolites EDP-938 Last Dose	—	822 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 35.2	—	525 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 30.0	—	—
Plasma Concentration at 12 Hours (C12) of EDP-938 and Its Metabolites EP-024636 Last Dose	—	228 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 27.8	—	153 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 28.9	—	—
Plasma Concentration at 12 Hours (C12) of EDP-938 and Its Metabolites EP-024594 First Dose	—	75.3 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 54.4	—	68.8 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 50.8	—	—
Plasma Concentration at 12 Hours (C12) of EDP-938 and Its Metabolites EP-024594 Last Dose	—	188 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 27.4	—	133 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 31.7	—	—
Plasma Concentration at 12 Hours (C12) of EDP-938 and Its Metabolites EP-024595 First Dose	—	100 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 79.6	—	99.3 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 75.4	—	—
Plasma Concentration at 12 Hours (C12) of EDP-938 and Its Metabolites EP-024595 Last Dose	—	705 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 39.1	—	515 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 40.2	—	—

SECONDARY outcome

Timeframe: Day 2 and Day 7; 24 hours post-dose

Population: Pharmacokinetic (PK) Analysis Set, defined as all Intent to Treat (ITT) participants with at least one post-dose PK result. Participants were excluded from the analysis if plasma concentrations were below the limit of quantification. C24 is only reported for once daily (OD) dosing groups relative to last dose. Data were specifically collected for OD dosing groups at the specified times.

The metabolites of EDP-938 that were assessed were EP-024636, EP-024594 and EP-024595.

Outcome measures

Outcome measures
Measure	Part 1: EDP-938 600 mg n=37 Participants Participants were administered EDP-938 oral suspension of 600 mg followed after 12 hours by a placebo once daily (OD) for a total of 10 doses over 5 days.	Part 1: EDP-938 500 mg Then 300 mg Participants were administered EDP-938 oral suspension as a single loading dose of 500 mg followed after 12 hours by EDP-938 300 mg twice daily (BID) (every 12 hours) for a total of 10 doses over 5 days.	Part 1: Placebo n=21 Participants Participants were administered a placebo BID (every 12 hours) for a total of 10 doses over 5 days.	Part 2: EDP-938 600 mg Then 300 mg Participants were administered a single loading dose of 600 mg EDP-938, followed by EDP-938 300 mg OD, and with dosing for 5 days.	Part 2: EDP-938 400 mg Then 200 mg Participants were administered a single loading dose of 400 mg EDP-938 followed by EDP-938 200 mg at 12 hours, then EDP-938 200 mg BID, and with dosing for 5 days.	Part 2: Placebo Participants were administered a placebo BID for 5 days, with dosing at 12 hour intervals.
Plasma Concentration at 24 Hours (C24) of EDP-938 and Its Metabolites EDP-938 First Dose	404 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 46.9	—	453 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 31.6	—	—	—
Plasma Concentration at 24 Hours (C24) of EDP-938 and Its Metabolites EDP-938 Last Dose	491 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 56.4	—	287 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 74.0	—	—	—
Plasma Concentration at 24 Hours (C24) of EDP-938 and Its Metabolites EP-024636 First Dose	121 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 43.5	—	136 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 30.5	—	—	—
Plasma Concentration at 24 Hours (C24) of EDP-938 and Its Metabolites EP-024636 Last Dose	148 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 44.4	—	88.3 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 64.8	—	—	—
Plasma Concentration at 24 Hours (C24) of EDP-938 and Its Metabolites EP-024594 First Dose	78.8 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 43.7	—	87.8 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 56.0	—	—	—
Plasma Concentration at 24 Hours (C24) of EDP-938 and Its Metabolites EP-024594 Last Dose	127 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 29.3	—	74.5 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 72.4	—	—	—
Plasma Concentration at 24 Hours (C24) of EDP-938 and Its Metabolites EP-024595 First Dose	142 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 57.5	—	163 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 79.4	—	—	—
Plasma Concentration at 24 Hours (C24) of EDP-938 and Its Metabolites EP-024595 Last Dose	461 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 41.6	—	287 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 93.8	—	—	—

SECONDARY outcome

Timeframe: Day 2: pre-dose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post-dose; and Day 7: 15, 24, 30, 36, 48, 60, and 72 hours post-dose

The metabolites of EDP-938 that were assessed were EP-024636, EP-024594 and EP-024595.

Outcome measures

Outcome measures
Measure	Part 1: EDP-938 600 mg n=38 Participants Participants were administered EDP-938 oral suspension of 600 mg followed after 12 hours by a placebo once daily (OD) for a total of 10 doses over 5 days.	Part 1: EDP-938 500 mg Then 300 mg n=37 Participants Participants were administered EDP-938 oral suspension as a single loading dose of 500 mg followed after 12 hours by EDP-938 300 mg twice daily (BID) (every 12 hours) for a total of 10 doses over 5 days.	Part 1: Placebo n=21 Participants Participants were administered a placebo BID (every 12 hours) for a total of 10 doses over 5 days.	Part 2: EDP-938 600 mg Then 300 mg n=20 Participants Participants were administered a single loading dose of 600 mg EDP-938, followed by EDP-938 300 mg OD, and with dosing for 5 days.	Part 2: EDP-938 400 mg Then 200 mg Participants were administered a single loading dose of 400 mg EDP-938 followed by EDP-938 200 mg at 12 hours, then EDP-938 200 mg BID, and with dosing for 5 days.	Part 2: Placebo Participants were administered a placebo BID for 5 days, with dosing at 12 hour intervals.
Area Under the Concentration Time Curve Time 0 to Time of Last Quantifiable Concentration (AUC0-last) of EDP-938 and Its Metabolites EDP-938 First Dose	16730 ng*hr/mL Geometric Coefficient of Variation 47.0	7540 ng*hr/mL Geometric Coefficient of Variation 45.8	16420 ng*hr/mL Geometric Coefficient of Variation 24.0	5970 ng*hr/mL Geometric Coefficient of Variation 40.5	—	—
Area Under the Concentration Time Curve Time 0 to Time of Last Quantifiable Concentration (AUC0-last) of EDP-938 and Its Metabolites EDP-938 Last Dose	32000 ng*hr/mL Geometric Coefficient of Variation 52.9	27300 ng*hr/mL Geometric Coefficient of Variation 40.8	20500 ng*hr/mL Geometric Coefficient of Variation 32.1	17800 ng*hr/mL Geometric Coefficient of Variation 29.0	—	—
Area Under the Concentration Time Curve Time 0 to Time of Last Quantifiable Concentration (AUC0-last) of EDP-938 and Its Metabolites EP-024636 First Dose	3800 ng*hr/mL Geometric Coefficient of Variation 42.9	1490 ng*hr/mL Geometric Coefficient of Variation 49.3	4080 ng*hr/mL Geometric Coefficient of Variation 36.2	1300 ng*hr/mL Geometric Coefficient of Variation 45.9	—	—
Area Under the Concentration Time Curve Time 0 to Time of Last Quantifiable Concentration (AUC0-last) of EDP-938 and Its Metabolites EP-024636 Last Dose	8680 ng*hr/mL Geometric Coefficient of Variation 42.9	7690 ng*hr/mL Geometric Coefficient of Variation 32.8	5550 ng*hr/mL Geometric Coefficient of Variation 24.1	5180 ng*hr/mL Geometric Coefficient of Variation 28.8	—	—
Area Under the Concentration Time Curve Time 0 to Time of Last Quantifiable Concentration (AUC0-last) of EDP-938 and Its Metabolites EP-024594 First Dose	1610 ng*hr/mL Geometric Coefficient of Variation 55.3	512 ng*hr/mL Geometric Coefficient of Variation 73.1	1740 ng*hr/mL Geometric Coefficient of Variation 64.2	487 ng*hr/mL Geometric Coefficient of Variation 51.5	—	—
Area Under the Concentration Time Curve Time 0 to Time of Last Quantifiable Concentration (AUC0-last) of EDP-938 and Its Metabolites EP-024594 Last Dose	6880 ng*hr/mL Geometric Coefficient of Variation 31.7	7160 ng*hr/mL Geometric Coefficient of Variation 27.5	4320 ng*hr/mL Geometric Coefficient of Variation 37.3	4990 ng*hr/mL Geometric Coefficient of Variation 31.6	—	—
Area Under the Concentration Time Curve Time 0 to Time of Last Quantifiable Concentration (AUC0-last) of EDP-938 and Its Metabolites EP-024595 First Dose	2510 ng*hr/mL Geometric Coefficient of Variation 72.1	540 ng*hr/mL Geometric Coefficient of Variation 95.6	2420 ng*hr/mL Geometric Coefficient of Variation 83.1	541 ng*hr/mL Geometric Coefficient of Variation 67.1	—	—
Area Under the Concentration Time Curve Time 0 to Time of Last Quantifiable Concentration (AUC0-last) of EDP-938 and Its Metabolites EP-024595 Last Dose	29600 ng*hr/mL Geometric Coefficient of Variation 40.5	36900 ng*hr/mL Geometric Coefficient of Variation 38.4	19700 ng*hr/mL Geometric Coefficient of Variation 77.1	25800 ng*hr/mL Geometric Coefficient of Variation 46.6	—	—

SECONDARY outcome

Timeframe: Day 2 and Day 6: Pre-dose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose; Day 7 only: 15, 24, 30, 36, 48, 60, and 72 hours post-dose

The metabolites of EDP-938 that were assessed were EP-024636, EP-024594 and EP-024595.

Outcome measures

Outcome measures
Measure	Part 1: EDP-938 600 mg n=38 Participants Participants were administered EDP-938 oral suspension of 600 mg followed after 12 hours by a placebo once daily (OD) for a total of 10 doses over 5 days.	Part 1: EDP-938 500 mg Then 300 mg n=35 Participants Participants were administered EDP-938 oral suspension as a single loading dose of 500 mg followed after 12 hours by EDP-938 300 mg twice daily (BID) (every 12 hours) for a total of 10 doses over 5 days.	Part 1: Placebo n=21 Participants Participants were administered a placebo BID (every 12 hours) for a total of 10 doses over 5 days.	Part 2: EDP-938 600 mg Then 300 mg n=20 Participants Participants were administered a single loading dose of 600 mg EDP-938, followed by EDP-938 300 mg OD, and with dosing for 5 days.	Part 2: EDP-938 400 mg Then 200 mg Participants were administered a single loading dose of 400 mg EDP-938 followed by EDP-938 200 mg at 12 hours, then EDP-938 200 mg BID, and with dosing for 5 days.	Part 2: Placebo Participants were administered a placebo BID for 5 days, with dosing at 12 hour intervals.
Area Under the Plasma Concentration-Time Curve Over the Dosing Interval (AUC0-tau) of EDP-938 and Its Metabolites EP-024595	12100 ng*hr/mL Geometric Coefficient of Variation 41.9	8950 ng*hr/mL Geometric Coefficient of Variation 36.7	8350 ng*hr/mL Geometric Coefficient of Variation 82.0	6210 ng*hr/mL Geometric Coefficient of Variation 44.3	—	—
Area Under the Plasma Concentration-Time Curve Over the Dosing Interval (AUC0-tau) of EDP-938 and Its Metabolites EDP-938	22300 ng*hr/mL Geometric Coefficient of Variation 46.5	12500 ng*hr/mL Geometric Coefficient of Variation 29.7	14100 ng*hr/mL Geometric Coefficient of Variation 18.5	8010 ng*hr/mL Geometric Coefficient of Variation 24.9	—	—
Area Under the Plasma Concentration-Time Curve Over the Dosing Interval (AUC0-tau) of EDP-938 and Its Metabolites EP-024636	5770 ng*hr/mL Geometric Coefficient of Variation 36.1	3270 ng*hr/mL Geometric Coefficient of Variation 25.2	3640 ng*hr/mL Geometric Coefficient of Variation 24.5	2210 ng*hr/mL Geometric Coefficient of Variation 30.8	—	—
Area Under the Plasma Concentration-Time Curve Over the Dosing Interval (AUC0-tau) of EDP-938 and Its Metabolites EP-024594	3830 ng*hr/mL Geometric Coefficient of Variation 30.6	2470 ng*hr/mL Geometric Coefficient of Variation 26.1	2410 ng*hr/mL Geometric Coefficient of Variation 45.4	1710 ng*hr/mL Geometric Coefficient of Variation 33.8	—	—

SECONDARY outcome

Timeframe: Day 2 to Day 18

Population: Pharmacokinetic (PK) Analysis Set, defined as all Intent to Treat (ITT) participants with at least one post-dose PK result.

The overall criteria to define correlation was based on identifying a PK AUC associated with a less favorable viral load AUC i.e. a low PK AUC and a high viral load AUC indicated a correlation.

Outcome measures

Outcome measures
Measure	Part 1: EDP-938 600 mg n=38 Participants Participants were administered EDP-938 oral suspension of 600 mg followed after 12 hours by a placebo once daily (OD) for a total of 10 doses over 5 days.	Part 1: EDP-938 500 mg Then 300 mg n=38 Participants Participants were administered EDP-938 oral suspension as a single loading dose of 500 mg followed after 12 hours by EDP-938 300 mg twice daily (BID) (every 12 hours) for a total of 10 doses over 5 days.	Part 1: Placebo n=21 Participants Participants were administered a placebo BID (every 12 hours) for a total of 10 doses over 5 days.	Part 2: EDP-938 600 mg Then 300 mg n=21 Participants Participants were administered a single loading dose of 600 mg EDP-938, followed by EDP-938 300 mg OD, and with dosing for 5 days.	Part 2: EDP-938 400 mg Then 200 mg Participants were administered a single loading dose of 400 mg EDP-938 followed by EDP-938 200 mg at 12 hours, then EDP-938 200 mg BID, and with dosing for 5 days.	Part 2: Placebo Participants were administered a placebo BID for 5 days, with dosing at 12 hour intervals.
Number of Participants With Correlation of Plasma Pharmacokinetic (PK) Area Under the Curve (AUC) and Viral Load AUC	0 Participants	0 Participants	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Day 2 to Day 18

Population: Pharmacokinetic (PK) Analysis Set, defined as all Intent to Treat (ITT) participants with at least one post-dose PK result.

The overall criteria to define correlation was based on identifying a PK AUC associated with a less favorable TSS AUC, i.e. a low PK AUC and a high TSS AUC indicated a correlation.

Outcome measures

Outcome measures
Measure	Part 1: EDP-938 600 mg n=38 Participants Participants were administered EDP-938 oral suspension of 600 mg followed after 12 hours by a placebo once daily (OD) for a total of 10 doses over 5 days.	Part 1: EDP-938 500 mg Then 300 mg n=38 Participants Participants were administered EDP-938 oral suspension as a single loading dose of 500 mg followed after 12 hours by EDP-938 300 mg twice daily (BID) (every 12 hours) for a total of 10 doses over 5 days.	Part 1: Placebo n=21 Participants Participants were administered a placebo BID (every 12 hours) for a total of 10 doses over 5 days.	Part 2: EDP-938 600 mg Then 300 mg n=21 Participants Participants were administered a single loading dose of 600 mg EDP-938, followed by EDP-938 300 mg OD, and with dosing for 5 days.	Part 2: EDP-938 400 mg Then 200 mg Participants were administered a single loading dose of 400 mg EDP-938 followed by EDP-938 200 mg at 12 hours, then EDP-938 200 mg BID, and with dosing for 5 days.	Part 2: Placebo Participants were administered a placebo BID for 5 days, with dosing at 12 hour intervals.
Number of Participants With Correlation of Plasma Pharmacokinetic (PK) Area Under the Curve (AUC) and Total Symptom Score (TSS) AUC	0 Participants	0 Participants	0 Participants	0 Participants	—	—

Adverse Events

Part 1: EDP-938 600 mg

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Part 1: EDP-938 500 mg Then 300 mg

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Part 1: Placebo

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Part 2: EDP-938 600 mg Then 300 mg

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Part 2: EDP-938 400 mg Then 200 mg

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Part 2: Placebo

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Part 1: EDP-938 600 mg n=38 participants at risk Participants were administered EDP-938 oral suspension of 600 mg followed after 12 hours by a placebo once daily (OD) for a total of 10 doses over 5 days.	Part 1: EDP-938 500 mg Then 300 mg n=38 participants at risk Participants were administered EDP-938 oral suspension as a single loading dose of 500 mg followed after 12 hours by EDP-938 300 mg twice daily (BID) (every 12 hours) for a total of 10 doses over 5 days.	Part 1: Placebo n=38 participants at risk Participants were administered a placebo BID (every 12 hours) for a total of 10 doses over 5 days.	Part 2: EDP-938 600 mg Then 300 mg n=21 participants at risk Participants were administered a single loading dose of 600 mg EDP-938, followed by EDP-938 300 mg OD, and with dosing for 5 days.	Part 2: EDP-938 400 mg Then 200 mg n=21 participants at risk Participants were administered a single loading dose of 400 mg EDP-938 followed by EDP-938 200 mg at 12 hours, then EDP-938 200 mg BID, and with dosing for 5 days.	Part 2: Placebo n=21 participants at risk Participants were administered a placebo BID for 5 days, with dosing at 12 hour intervals.
Ear and labyrinth disorders Ear pain	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	2.6% 1/38 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	5.3% 2/38 • Number of events 2 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	4.8% 1/21 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.
Ear and labyrinth disorders Hypoacusis	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	2.6% 1/38 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.
Eye disorders Blepharospasm	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	2.6% 1/38 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.
Eye disorders Conjunctival haemorrhage	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	2.6% 1/38 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.
Eye disorders Ocular hyperaemia	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	2.6% 1/38 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	2.6% 1/38 • Number of events 2 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.
Gastrointestinal disorders Abdominal pain	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	5.3% 2/38 • Number of events 2 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	2.6% 1/38 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	4.8% 1/21 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.
Gastrointestinal disorders Diarrhoea	7.9% 3/38 • Number of events 3 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	7.9% 3/38 • Number of events 3 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	4.8% 1/21 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	4.8% 1/21 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.
Gastrointestinal disorders Dyspepsia	2.6% 1/38 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	5.3% 2/38 • Number of events 2 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.
Gastrointestinal disorders Haemorrhoids	2.6% 1/38 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.
Gastrointestinal disorders Nausea	2.6% 1/38 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	2.6% 1/38 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	7.9% 3/38 • Number of events 3 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	4.8% 1/21 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	14.3% 3/21 • Number of events 3 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.
Gastrointestinal disorders Vomiting	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	2.6% 1/38 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	2.6% 1/38 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	4.8% 1/21 • Number of events 2 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	4.8% 1/21 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.
Gastrointestinal disorders Abdominal tenderness	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	4.8% 1/21 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.
General disorders Catheter site related reaction	2.6% 1/38 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	2.6% 1/38 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	5.3% 2/38 • Number of events 2 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.
General disorders Chest discomfort	2.6% 1/38 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	2.6% 1/38 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	2.6% 1/38 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.
General disorders Pyrexia	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	2.6% 1/38 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	4.8% 1/21 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.
General disorders Thirst	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	2.6% 1/38 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.
General disorders Vessel puncture site haematoma	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	2.6% 1/38 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.
General disorders Vessel puncture site pain	2.6% 1/38 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	4.8% 1/21 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.
General disorders Feeling hot	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	4.8% 1/21 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.
General disorders Vessel puncture site paraesthesia	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	4.8% 1/21 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.
Immune system disorders Hypersensitivity	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	2.6% 1/38 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.
Infections and infestations Angular cheilitis	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	2.6% 1/38 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.
Infections and infestations Gastroenteritis	2.6% 1/38 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	2.6% 1/38 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.
Infections and infestations Herpes simplex	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	2.6% 1/38 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.
Infections and infestations Upper respiratory tract infection	5.3% 2/38 • Number of events 2 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	5.3% 2/38 • Number of events 2 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	10.5% 4/38 • Number of events 4 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	4.8% 1/21 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	9.5% 2/21 • Number of events 2 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	4.8% 1/21 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.
Infections and infestations Viral upper respiratory tract infection	2.6% 1/38 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	2.6% 1/38 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	9.5% 2/21 • Number of events 2 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.
Infections and infestations Urinary tract infection	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	4.8% 1/21 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.
Infections and infestations Viral tonsillitis	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	4.8% 1/21 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.
Investigations Alanine aminotransferase increased	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	5.3% 2/38 • Number of events 2 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	5.3% 2/38 • Number of events 2 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.
Investigations Forced expiratory volume decreased	5.3% 2/38 • Number of events 3 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	2.6% 1/38 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.
Investigations Aspartate aminotransferase increased	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	4.8% 1/21 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.
Investigations FEV1/FVC ratio decreased	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	4.8% 1/21 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.
Investigations Forced vital capacity decreased	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	4.8% 1/21 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.
Metabolism and nutrition disorders Decreased appetite	2.6% 1/38 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	5.3% 2/38 • Number of events 2 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.
Musculoskeletal and connective tissue disorders Back pain	2.6% 1/38 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	2.6% 1/38 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	2.6% 1/38 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	2.6% 1/38 • Number of events 2 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	2.6% 1/38 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	9.5% 2/21 • Number of events 2 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	2.6% 1/38 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	2.6% 1/38 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	4.8% 1/21 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	4.8% 1/21 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.
Injury, poisoning and procedural complications Soft tissue injury	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	4.8% 1/21 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.
Nervous system disorders Dizziness	10.5% 4/38 • Number of events 4 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	2.6% 1/38 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	9.5% 2/21 • Number of events 2 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	4.8% 1/21 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.
Nervous system disorders Headache	10.5% 4/38 • Number of events 5 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	2.6% 1/38 • Number of events 2 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	7.9% 3/38 • Number of events 3 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	4.8% 1/21 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	9.5% 2/21 • Number of events 2 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.
Reproductive system and breast disorders Dysmenorrhoea	2.6% 1/38 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	2.6% 1/38 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	2.6% 1/38 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	4.8% 1/21 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	2.6% 1/38 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	4.8% 1/21 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	2.6% 1/38 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	4.8% 1/21 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	4.8% 1/21 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	2.6% 1/38 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	4.8% 1/21 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.
Skin and subcutaneous tissue disorders Rash	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	5.3% 2/38 • Number of events 2 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	4.8% 1/21 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	2.6% 1/38 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.
Skin and subcutaneous tissue disorders Skin irritation	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	5.3% 2/38 • Number of events 2 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	4.8% 1/21 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	4.8% 1/21 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.
Skin and subcutaneous tissue disorders Skin mass	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	4.8% 1/21 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.
Renal and urinary disorders Dysuria	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	4.8% 1/21 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.
Renal and urinary disorders Micturition urgency	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	4.8% 1/21 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.
Renal and urinary disorders Pollakiuria	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/38 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	4.8% 1/21 • Number of events 1 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.	0.00% 0/21 • All cause mortality was monitored from enrollment until end of study (Day 28) for the safety analysis population which included all participants who received challenge virus, regardless of whether they received study drug or not. Treatment-emergent serious and other adverse events (AEs) were monitored from Day 2 to Day 28 and only included participants in the safety analysis population who received study drug. An adverse event (AE) was defined as any untoward medical occurrence in participants (any unfavourable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease temporally associated with the investigational medicinal product \[IMP\], whether or not considered related to IMP, or for Human Viral Challenge studies, the Challenge Virus). AEs were recorded in the source documents as they are reported, whether volunteered by a participant or in response to questioning.

Additional Information

Guy De La Rosa, MD, Senior Medical Director, Infectious Diseases

Enanta Pharmaceuticals, Inc.

Phone: +1 857 760 0548

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee First publication of Sponsor Data shall be made by Sponsor with input from principal investigator (PIs). If no publication within 24 months after study completion, PI may publish Sponsor Data with sponsor's prior written consent. Prior to submitting or presenting data, Sponsor has at least 60 days to to review and comment.
Publication restrictions are in place

Restriction type: OTHER