Trial Outcomes & Findings for A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Brensocatib Tablets in Adults With Cystic Fibrosis (NCT NCT05090904)

NCT ID: NCT05090904

Last Updated: 2026-03-12

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

29 participants

Primary outcome timeframe

Predose and at 0.5, 1, 2, 4, 6, 8, 24, and 168 hours postdose on Day 28

Results posted on

2026-03-12

Participant Flow

Participants took part in the study at investigational sites in the United States.

Participant milestones

Participant milestones
Measure	Brensocatib 10 mg Participants received brensocatib at a dose of 10 mg orally once per day for 28 days.	Brensocatib 25 mg Participants received brensocatib at a dose of 25 mg orally once per day for 28 days.	Brensocatib 40 mg Participants received brensocatib at a dose of 40 mg orally once per day for 28 days.	Placebo Participants received a placebo matching brensocatib orally once per day for 28 days.
Overall Study STARTED	8	8	8	5
Overall Study COMPLETED	8	8	8	5
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Brensocatib Tablets in Adults With Cystic Fibrosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Brensocatib 10 mg n=8 Participants Participants received brensocatib at a dose of 10 mg orally once per day for 28 days.	Brensocatib 25 mg n=8 Participants Participants received brensocatib at a dose of 25 mg orally once per day for 28 days.	Brensocatib 40 mg n=8 Participants Participants received brensocatib at a dose of 40 mg orally once per day for 28 days.	Placebo n=5 Participants Participants received a placebo matching brensocatib orally once per day for 28 days.	Total n=29 Participants Total of all reporting groups
Age, Continuous	38.3 Years STANDARD_DEVIATION 14.86 • n=9 Participants	42.9 Years STANDARD_DEVIATION 16.54 • n=9 Participants	34.6 Years STANDARD_DEVIATION 15.95 • n=18 Participants	34.6 Years STANDARD_DEVIATION 9.79 • n=15 Participants	37.9 Years STANDARD_DEVIATION 14.59 • n=60 Participants
Sex: Female, Male Female	2 Participants n=9 Participants	5 Participants n=9 Participants	2 Participants n=18 Participants	2 Participants n=15 Participants	11 Participants n=60 Participants
Sex: Female, Male Male	6 Participants n=9 Participants	3 Participants n=9 Participants	6 Participants n=18 Participants	3 Participants n=15 Participants	18 Participants n=60 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=9 Participants	1 Participants n=9 Participants	1 Participants n=18 Participants	1 Participants n=15 Participants	4 Participants n=60 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=9 Participants	0 Participants n=9 Participants	0 Participants n=18 Participants	0 Participants n=15 Participants	0 Participants n=60 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	7 Participants n=9 Participants	7 Participants n=9 Participants	7 Participants n=18 Participants	4 Participants n=15 Participants	25 Participants n=60 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9 Participants	0 Participants n=9 Participants	0 Participants n=18 Participants	0 Participants n=15 Participants	0 Participants n=60 Participants
Race (NIH/OMB) Asian	0 Participants n=9 Participants	0 Participants n=9 Participants	1 Participants n=18 Participants	0 Participants n=15 Participants	1 Participants n=60 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9 Participants	0 Participants n=9 Participants	0 Participants n=18 Participants	0 Participants n=15 Participants	0 Participants n=60 Participants
Race (NIH/OMB) Black or African American	0 Participants n=9 Participants	0 Participants n=9 Participants	1 Participants n=18 Participants	0 Participants n=15 Participants	1 Participants n=60 Participants
Race (NIH/OMB) White	7 Participants n=9 Participants	8 Participants n=9 Participants	6 Participants n=18 Participants	5 Participants n=15 Participants	26 Participants n=60 Participants
Race (NIH/OMB) More than one race	0 Participants n=9 Participants	0 Participants n=9 Participants	0 Participants n=18 Participants	0 Participants n=15 Participants	0 Participants n=60 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=9 Participants	0 Participants n=9 Participants	0 Participants n=18 Participants	0 Participants n=15 Participants	1 Participants n=60 Participants

PRIMARY outcome

Timeframe: Predose and 0.5, 1, 2, 4, 6, 8, and 24 hours postdose on Day 1

Population: Pharmacokinetic (PK) Analysis Set included all randomized participants who received at least 1 dose of brensocatib (actual treatment) and had sufficient data to calculate at least 1 PK parameter.

Outcome measures

Outcome measures
Measure	Brensocatib 10 mg n=8 Participants Participants received brensocatib at a dose of 10 mg orally once per day for 28 days.	Brensocatib 25 mg n=8 Participants Participants received brensocatib at a dose of 25 mg orally once per day for 28 days.	Brensocatib 40 mg n=8 Participants Participants received brensocatib at a dose of 40 mg orally once per day for 28 days.	Placebo Participants received a placebo matching brensocatib orally once per day for 28 days.
Maximum Plasma Concentration (Cmax) of Brensocatib on Day 1	62.4 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 41.3	136 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 25.9	338 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 17.7	—

PRIMARY outcome

Timeframe: Predose and at 0.5, 1, 2, 4, 6, 8, 24, and 168 hours postdose on Day 28

Population: PK Analysis Set included all randomized participants who received at least 1 dose of brensocatib (actual treatment) and had sufficient data to calculate at least 1 PK parameter. Overall number analyzed is the number of participants with data available for analyses.

Outcome measures

Outcome measures
Measure	Brensocatib 10 mg n=8 Participants Participants received brensocatib at a dose of 10 mg orally once per day for 28 days.	Brensocatib 25 mg n=7 Participants Participants received brensocatib at a dose of 25 mg orally once per day for 28 days.	Brensocatib 40 mg n=8 Participants Participants received brensocatib at a dose of 40 mg orally once per day for 28 days.	Placebo Participants received a placebo matching brensocatib orally once per day for 28 days.
Cmax of Brensocatib on Day 28	86.2 ng/mL Geometric Coefficient of Variation 33.1	234 ng/mL Geometric Coefficient of Variation 37.5	469 ng/mL Geometric Coefficient of Variation 34.0	—

PRIMARY outcome

Timeframe: Predose and 0.5, 1, 2, 4, 6, 8, and 24 hours postdose on Day 1

Population: PK Analysis Set included all randomized participants who received at least 1 dose of brensocatib (actual treatment) and had sufficient data to calculate at least 1 PK parameter.

Outcome measures

Outcome measures
Measure	Brensocatib 10 mg n=8 Participants Participants received brensocatib at a dose of 10 mg orally once per day for 28 days.	Brensocatib 25 mg n=8 Participants Participants received brensocatib at a dose of 25 mg orally once per day for 28 days.	Brensocatib 40 mg n=8 Participants Participants received brensocatib at a dose of 40 mg orally once per day for 28 days.	Placebo Participants received a placebo matching brensocatib orally once per day for 28 days.
Time to Maximum Plasma Concentration (Tmax) of Brensocatib on Day 1	2.0 hours Interval 1.0 to 24.8	1.5 hours Interval 1.0 to 4.1	1.5 hours Interval 0.6 to 24.9	—

PRIMARY outcome

Timeframe: Predose and at 0.5, 1, 2, 4, 6, 8, 24, and 168 hours postdose on Day 28

Outcome measures

Outcome measures
Measure	Brensocatib 10 mg n=8 Participants Participants received brensocatib at a dose of 10 mg orally once per day for 28 days.	Brensocatib 25 mg n=7 Participants Participants received brensocatib at a dose of 25 mg orally once per day for 28 days.	Brensocatib 40 mg n=8 Participants Participants received brensocatib at a dose of 40 mg orally once per day for 28 days.	Placebo Participants received a placebo matching brensocatib orally once per day for 28 days.
Tmax of Brensocatib on Day 28	1.9 hours Interval 0.5 to 4.0	2.0 hours Interval 1.0 to 4.0	2.0 hours Interval 1.0 to 4.0	—

PRIMARY outcome

Timeframe: Predose and 0.5, 1, 2, 4, 6, 8, and 24 hours postdose on Day 1

Population: PK Analysis Set included all randomized participants who received at least 1 dose of brensocatib (actual treatment) and had sufficient data to calculate at least 1 PK parameter.

Outcome measures

Outcome measures
Measure	Brensocatib 10 mg n=8 Participants Participants received brensocatib at a dose of 10 mg orally once per day for 28 days.	Brensocatib 25 mg n=8 Participants Participants received brensocatib at a dose of 25 mg orally once per day for 28 days.	Brensocatib 40 mg n=8 Participants Participants received brensocatib at a dose of 40 mg orally once per day for 28 days.	Placebo Participants received a placebo matching brensocatib orally once per day for 28 days.
Area Under the Concentration-time Curve From Time 0 to 24 Hours Postdose (AUC0-24) of Brensocatib in Plasma on Day 1	792 hours*ng/mL Geometric Coefficient of Variation 49.5	1600 hours*ng/mL Geometric Coefficient of Variation 22.0	3510 hours*ng/mL Geometric Coefficient of Variation 35.0	—

PRIMARY outcome

Timeframe: Predose and at 0.5, 1, 2, 4, 6, 8, and 24 hours postdose on Day 28

Outcome measures

Outcome measures
Measure	Brensocatib 10 mg n=8 Participants Participants received brensocatib at a dose of 10 mg orally once per day for 28 days.	Brensocatib 25 mg n=7 Participants Participants received brensocatib at a dose of 25 mg orally once per day for 28 days.	Brensocatib 40 mg n=7 Participants Participants received brensocatib at a dose of 40 mg orally once per day for 28 days.	Placebo Participants received a placebo matching brensocatib orally once per day for 28 days.
AUC0-24 of Brensocatib in Plasma on Day 28	1050 hours*ng/mL Geometric Coefficient of Variation 33.1	3640 hours*ng/mL Geometric Coefficient of Variation 32.7	5950 hours*ng/mL Geometric Coefficient of Variation 40.4	—

PRIMARY outcome

Timeframe: Predose and at 0.5, 1, 2, 4, 6, 8, 24, and 168 hours postdose on Day 28

Outcome measures

Outcome measures
Measure	Brensocatib 10 mg n=8 Participants Participants received brensocatib at a dose of 10 mg orally once per day for 28 days.	Brensocatib 25 mg n=7 Participants Participants received brensocatib at a dose of 25 mg orally once per day for 28 days.	Brensocatib 40 mg n=7 Participants Participants received brensocatib at a dose of 40 mg orally once per day for 28 days.	Placebo Participants received a placebo matching brensocatib orally once per day for 28 days.
Elimination Half-life (t1/2) of Brensocatib in Plasma on Day 28	29.6 hours Geometric Coefficient of Variation 16.5	32.4 hours Geometric Coefficient of Variation 23.0	36.0 hours Geometric Coefficient of Variation 39.5	—

PRIMARY outcome

Timeframe: Up to Day 56

Population: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.

A TEAE is defined as any adverse event (AE) that occurred after the first dose of study investigational medicinal product (IMP) and within 28 days after the last dose of study IMP.

Outcome measures

Outcome measures
Measure	Brensocatib 10 mg n=8 Participants Participants received brensocatib at a dose of 10 mg orally once per day for 28 days.	Brensocatib 25 mg n=8 Participants Participants received brensocatib at a dose of 25 mg orally once per day for 28 days.	Brensocatib 40 mg n=8 Participants Participants received brensocatib at a dose of 40 mg orally once per day for 28 days.	Placebo n=5 Participants Participants received a placebo matching brensocatib orally once per day for 28 days.
Number of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE)	4 Participants	5 Participants	4 Participants	2 Participants

SECONDARY outcome

Timeframe: Day 1: Predose and 0.5, 1, 2, 4, 6, 8, and 24 hours postdose; Day 28: Predose and at 0.5, 1, 2, 4, 6, 8, 24 and 168 hours postdose

Population: PK Analysis Set included all randomized participants who received at least 1 dose of brensocatib (actual treatment) and had sufficient data to calculate at least 1 PK parameter. Number analyzed signifies the number of participants with data available for analysis at the specified time point.

Analysis of dose dependency for brensocatib Cmax was performed using a power law model. The logarithm of the Cmax was linearly related to the logarithm of the dose using a linear regression analysis. Slope of the regression and corresponding 90% CIs are presented. Slope (90% CI): log(PK parameter) = intercept + slope \* log(dose) + error term, for relationship between each of the dose levels. All 3 dose levels are included in the same model for the dose-exposure relationship.

Outcome measures

Outcome measures
Measure	Brensocatib 10 mg n=24 Participants Participants received brensocatib at a dose of 10 mg orally once per day for 28 days.	Brensocatib 25 mg Participants received brensocatib at a dose of 25 mg orally once per day for 28 days.	Brensocatib 40 mg Participants received brensocatib at a dose of 40 mg orally once per day for 28 days.	Placebo Participants received a placebo matching brensocatib orally once per day for 28 days.
Dose Proportionality of Brensocatib for Dose Levels 10mg to 40mg Using Brensocatib Cmax After Administration of Brensocatib on Days 1 and 28 Day 1	1.168 log(ng/ml) per log(mg) Interval 0.97 to 1.37	—	—	—
Dose Proportionality of Brensocatib for Dose Levels 10mg to 40mg Using Brensocatib Cmax After Administration of Brensocatib on Days 1 and 28 Day 28	1.206 log(ng/ml) per log(mg) Interval 1.0 to 1.41	—	—	—

SECONDARY outcome

Timeframe: Day 1: Predose and 0.5, 1, 2, 4, 6, 8, and 24 hours postdose; Day 28: Predose and at 0.5, 1, 2, 4, 6, 8, and 24 hours postdose

Population: PK Analysis Set included all randomized participants who received at least 1 dose of brensocatib (actual treatment) and had sufficient data to calculate at least 1 PK parameter. Number analyzed signifies the number of participants with data available for analysis at the specified time point.

Analysis of dose dependency for brensocatib AUC0-24 was performed using a power law model. The logarithm of the AUC0-24 was linearly related to the logarithm of the dose using a linear regression analysis. Slope of the regression and corresponding 90% CIs are presented. Slope (90% CI): log(PK parameter) = intercept + slope \* log(dose) + error term, for relationship between each of the dose levels. All 3 dose levels are included in the same model for the dose-exposure relationship.

Outcome measures

Outcome measures
Measure	Brensocatib 10 mg n=24 Participants Participants received brensocatib at a dose of 10 mg orally once per day for 28 days.	Brensocatib 25 mg Participants received brensocatib at a dose of 25 mg orally once per day for 28 days.	Brensocatib 40 mg Participants received brensocatib at a dose of 40 mg orally once per day for 28 days.	Placebo Participants received a placebo matching brensocatib orally once per day for 28 days.
Dose Proportionality of Brensocatib for Dose Levels 10mg to 40mg Using Brensocatib AUC0-24 After Administration of Brensocatib on Days 1 and 28 Day 1	1.033 log(ng*h/mL) per log(mg) Interval 0.8 to 1.26	—	—	—
Dose Proportionality of Brensocatib for Dose Levels 10mg to 40mg Using Brensocatib AUC0-24 After Administration of Brensocatib on Days 1 and 28 Day 28	1.267 log(ng*h/mL) per log(mg) Interval 1.05 to 1.48	—	—	—

SECONDARY outcome

Timeframe: Day 1: Predose and 0.5, 1, 2, 4, 6, 8, and 24 hours postdose; Day 28: Predose and at 0.5, 1, 2, 4, 6, 8, 24 and 168 hours postdose

Population: PK Analysis Set included all randomized participants who received at least 1 dose of brensocatib (actual treatment) and had sufficient data to calculate at least 1 PK parameter. Number analyzed signifies the number of participants with data available for analysis at the specified time point.

Outcome measures

Outcome measures
Measure	Brensocatib 10 mg n=8 Participants Participants received brensocatib at a dose of 10 mg orally once per day for 28 days.	Brensocatib 25 mg n=8 Participants Participants received brensocatib at a dose of 25 mg orally once per day for 28 days.	Brensocatib 40 mg n=8 Participants Participants received brensocatib at a dose of 40 mg orally once per day for 28 days.	Placebo Participants received a placebo matching brensocatib orally once per day for 28 days.
AUClast of Brensocatib in Plasma on Days 1 and 28 Day 28	2210 hours*ng/mL Geometric Coefficient of Variation 40.6	8220 hours*ng/mL Geometric Coefficient of Variation 44.1	13700 hours*ng/mL Geometric Coefficient of Variation 58.6	—
AUClast of Brensocatib in Plasma on Days 1 and 28 Day 1	792 hours*ng/mL Geometric Coefficient of Variation 49.5	1600 hours*ng/mL Geometric Coefficient of Variation 22.0	3510 hours*ng/mL Geometric Coefficient of Variation 35.0	—

SECONDARY outcome

Timeframe: Day 1: Predose and 0.5, 1, 2, 4, 6, 8, and 24 hours postdose; Day 28: Predose and at 0.5, 1, 2, 4, 6, 8, 24 and 168 hours postdose

Population: PK Analysis Set included all randomized participants who received at least 1 dose of brensocatib (actual treatment) and had sufficient data to calculate at least 1 PK parameter. Number analyzed signifies the number of participants with data available for analysis at the specified time point.

Analysis of dose dependency for brensocatib AUClast was performed using a power law model. The logarithm of the AUClast was linearly related to the logarithm of the dose using a linear regression analysis. Slope of the regression and corresponding 90% CIs are presented. Slope (90% CI): log(PK parameter) = intercept + slope \* log(dose) + error term, for relationship between each of the dose levels. All 3 dose levels are included in the same model for the dose-exposure relationship.

Outcome measures

Outcome measures
Measure	Brensocatib 10 mg n=24 Participants Participants received brensocatib at a dose of 10 mg orally once per day for 28 days.	Brensocatib 25 mg Participants received brensocatib at a dose of 25 mg orally once per day for 28 days.	Brensocatib 40 mg Participants received brensocatib at a dose of 40 mg orally once per day for 28 days.	Placebo Participants received a placebo matching brensocatib orally once per day for 28 days.
Dose Proportionality of Brensocatib for Dose Levels 10mg to 40mg Using Brensocatib AUClast, After Administration of Brensocatib on Days 1 and 28 Day 1	1.033 log(ng*h/mL) per log(mg) Interval 0.8 to 1.26	—	—	—
Dose Proportionality of Brensocatib for Dose Levels 10mg to 40mg Using Brensocatib AUClast, After Administration of Brensocatib on Days 1 and 28 Day 28	1.334 log(ng*h/mL) per log(mg) Interval 1.05 to 1.61	—	—	—

Adverse Events

Brensocatib 10 mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Brensocatib 25 mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Brensocatib 40 mg

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Brensocatib 10 mg n=8 participants at risk Participants received brensocatib at a dose of 10 mg orally once per day for 28 days.	Brensocatib 25 mg n=8 participants at risk Participants received brensocatib at a dose of 25 mg orally once per day for 28 days.	Brensocatib 40 mg n=8 participants at risk Participants received brensocatib at a dose of 40 mg orally once per day for 28 days.	Placebo n=5 participants at risk Participants received a placebo matching brensocatib orally once per day for 28 days.
Infections and infestations Infective pulmonary exacerbation of cystic fibrosis	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.

Other adverse events

Additional Information

Insmed Medical Information

Insmed Incorporated

Phone: 1-844-446-7633

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Publication restrictions are in place

Restriction type: OTHER

Measure	Brensocatib 10 mg n=8 participants at risk Participants received brensocatib at a dose of 10 mg orally once per day for 28 days.	Brensocatib 25 mg n=8 participants at risk Participants received brensocatib at a dose of 25 mg orally once per day for 28 days.	Brensocatib 40 mg n=8 participants at risk Participants received brensocatib at a dose of 40 mg orally once per day for 28 days.	Placebo n=5 participants at risk Participants received a placebo matching brensocatib orally once per day for 28 days.
Infections and infestations Infective pulmonary exacerbation of cystic fibrosis	25.0% 2/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
Infections and infestations COVID-19	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal pain	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	20.0% 1/5 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	12.5% 1/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Sputum increased	25.0% 2/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
Nervous system disorders Headache	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	25.0% 2/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	20.0% 1/5 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	20.0% 1/5 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Gastric fistula	12.5% 1/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Toothache	12.5% 1/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Vomiting	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
General disorders Chills	12.5% 1/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
General disorders Fatigue	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
General disorders Pyrexia	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
Immune system disorders Drug hypersensitivity	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
Eye disorders Conjunctivitis	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Gastroenteritis	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	20.0% 1/5 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
Infections and infestations Influenza	12.5% 1/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
Eye disorders Corneal abrasion	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
Infections and infestations Influenza A virus test positive	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
Nervous system disorders Ophthalmic migraine	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
Renal and urinary disorders Chromaturia	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
Renal and urinary disorders Renal pain	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Nasal congestion	12.5% 1/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Tonsillar disorder	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Tonsillolith	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Dermatitis contact	12.5% 1/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	20.0% 1/5 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Rash	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/5 • Up to Day 56 Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.