Trial Outcomes & Findings for Safety, Tolerability, Pharmacokinetics and Protective Efficacy of MAM01 in Healthy Adults (NCT NCT05891236)
NCT ID: NCT05891236
Last Updated: 2026-06-12
Results Overview
Solicited AEs were defined events participants were specifically asked about, which were recorded by participants in the memory aid card. Solicited AES included local injection site AEs (pain, redness, swelling, itching and bruising) and systemic AEs (fever, chills, headache, fatigue, nausea, muscle pain and joint pain). A Solicited AE does not necessarily have a causal relationship with the intervention.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
63 participants
Primary outcome timeframe
Day 1 to Day 7 post dose
Results posted on
2026-06-12
Participant Flow
A two-part randomized, dose-escalation study to assess anti-malarial human monoclonal antibody MAM01 in healthy, malaria-naïve adults. Part A: double-blind, placebo-controlled, single-ascending dose (SAD) study, while Part B: dose expansion was open-label. The study evaluated safety, tolerability, pharmacokinetics, and protective efficacy of MAM01 against controlled human malaria infection (CHMI) with Plasmodium falciparum NF54. Safety and PK of repeat subcutaneous dosing were also evaluated.
In Part A, 37 of 38 participants were randomized to MAM01 or placebo, with 1 participant serving as an untreated infectivity control. Ten randomized participants did not undergo CHMI due to rescheduling secondary to a failure to generate infectious mosquitoes. In Part B, 25 participants were enrolled; 18 were dosed, 1 participant was randomized but withdrew prior to dosing, and 6 participants served as infectivity controls. One participant did not undergo CHMI due to concurrent illness.
Participant milestones
| Measure |
Part A (SAD Cohort 1): MAM01 1.5 mg/kg IV
Participants were randomized to receive a single IV dose of MAM01 1.5 mg/kg.
|
Part A (SAD Cohort 2): MAM01 5 mg/kg SC (Repeat Dose 5 mg/kg SC)
Participants were randomized to receive single SC dose of MAM01 5 mg/kg. Participants received a second dose of 5 mg/kg SC of MAM01 following CHMI, regardless of the initial randomized treatment allocation.
|
Part A (SAD Cohort 3): MAM01 5 mg/kg IV (Repeat Dose 5 mg/kg SC)
Participants were randomized to receive Single IV dose of MAM01 5 mg/kg. Participants received a second dose of 5 mg/kg SC of MAM01 following CHMI, regardless of the initial randomized treatment allocation.
|
Part A (SAD Cohort 4): MAM01 10 mg/kg IV
Participants were randomized to receive a single IV dose of MAM01 10 mg/kg.
|
Part A (SAD Cohort 5): MAM01 40 mg/kg IV
Participants were randomized to receive a single IV dose of MAM01 40 mg/kg.
|
Part A: Placebo
Participants were randomized to receive a single IV dose of placebo (formulation buffer without MAM01 active ingredient). One randomized Cohort 2 placebo participant received MAM01 SC following CHMI as the second dose, per protocol.
|
Part A: Infectivity Controls
Non-randomized participants were enrolled prior to CHMI, did not receive treatment and acted as additional infectivity controls.
|
Part B (Cohort 6, Group 1): MAM01 450 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 450 mg/kg.
|
Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 600 mg/kg.
|
Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 900 mg/kg.
|
Part B: Infectivity Controls
Non-randomized participants were enrolled prior to CHMI, did not receive treatment and acted as infectivity controls.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
6
|
7
|
1
|
6
|
7
|
6
|
6
|
|
Overall Study
Received SC Dose
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
5
|
4
|
5
|
6
|
6
|
5
|
1
|
6
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
1
|
0
|
0
|
2
|
0
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part A (SAD Cohort 1): MAM01 1.5 mg/kg IV
Participants were randomized to receive a single IV dose of MAM01 1.5 mg/kg.
|
Part A (SAD Cohort 2): MAM01 5 mg/kg SC (Repeat Dose 5 mg/kg SC)
Participants were randomized to receive single SC dose of MAM01 5 mg/kg. Participants received a second dose of 5 mg/kg SC of MAM01 following CHMI, regardless of the initial randomized treatment allocation.
|
Part A (SAD Cohort 3): MAM01 5 mg/kg IV (Repeat Dose 5 mg/kg SC)
Participants were randomized to receive Single IV dose of MAM01 5 mg/kg. Participants received a second dose of 5 mg/kg SC of MAM01 following CHMI, regardless of the initial randomized treatment allocation.
|
Part A (SAD Cohort 4): MAM01 10 mg/kg IV
Participants were randomized to receive a single IV dose of MAM01 10 mg/kg.
|
Part A (SAD Cohort 5): MAM01 40 mg/kg IV
Participants were randomized to receive a single IV dose of MAM01 40 mg/kg.
|
Part A: Placebo
Participants were randomized to receive a single IV dose of placebo (formulation buffer without MAM01 active ingredient). One randomized Cohort 2 placebo participant received MAM01 SC following CHMI as the second dose, per protocol.
|
Part A: Infectivity Controls
Non-randomized participants were enrolled prior to CHMI, did not receive treatment and acted as additional infectivity controls.
|
Part B (Cohort 6, Group 1): MAM01 450 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 450 mg/kg.
|
Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 600 mg/kg.
|
Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 900 mg/kg.
|
Part B: Infectivity Controls
Non-randomized participants were enrolled prior to CHMI, did not receive treatment and acted as infectivity controls.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Move from study area-
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Other
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Safety, Tolerability, Pharmacokinetics and Protective Efficacy of MAM01 in Healthy Adults
Baseline characteristics by cohort
| Measure |
Part A (SAD Cohort 1): MAM01 1.5 mg/kg IV
n=6 Participants
Participants were randomized to receive a single IV dose of MAM01 1.5 mg/kg.
|
Part A (SAD Cohort 2): MAM01 5 mg/kg SC (Repeat Dose 5 mg/kg SC)
n=6 Participants
Participants were randomized to receive single SC dose of MAM01 5 mg/kg. Participants received a second dose of MAM01 5 mg/kg SC following CHMI, regardless of the initial randomized treatment allocation.
|
Part A (SAD Cohort 3): MAM01 5 mg/kg IV (Repeat Dose 5 mg/kg SC)
n=6 Participants
Participants were randomized to receive Single IV dose of MAM01 5 mg/kg. Participants received a second dose of MAM01 5 mg/kg SC following CHMI, regardless of the initial randomized treatment allocation.
|
Part A (SAD Cohort 4): MAM01 10 mg/kg IV
n=6 Participants
Participants were randomized to receive a single IV dose of MAM01 10 mg/kg.
|
Part A (SAD Cohort 5): MAM01 40 mg/kg IV
n=6 Participants
Participants were randomized to receive a single IV dose of MAM01 40 mg/kg.
|
Part A: Placebo
n=7 Participants
Participants were randomized to receive a single IV dose of placebo (formulation buffer without MAM01 active ingredient). They also served as infectivity controls for the CHMI.
|
Part A: Infectivity Controls
n=1 Participants
Non-randomized participants were enrolled prior to CHMI, did not receive treatment and acted as additional infectivity controls.
|
Part B (Cohort 6, Group 1): MAM01 450 mg/kg SC
n=6 Participants
Participants were randomized to receive single SC dose of MAM01 450 mg/kg.
|
Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC
n=6 Participants
Participants were randomized to receive single SC dose of MAM01 600 mg/kg.
|
Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC
n=6 Participants
Participants were randomized to receive single SC dose of MAM01 900 mg/kg.
|
Part B: Infectivity Controls
n=6 Participants
Non-randomized participants were enrolled prior to CHMI, did not receive treatment and acted as infectivity controls.
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
28.5 Years
STANDARD_DEVIATION 4.28 • n=9 Participants
|
26.8 Years
STANDARD_DEVIATION 7.08 • n=27 Participants
|
35.3 Years
STANDARD_DEVIATION 7.58 • n=267 Participants
|
32.7 Years
STANDARD_DEVIATION 8.55 • n=265 Participants
|
32.3 Years
STANDARD_DEVIATION 8.19 • n=568 Participants
|
29.1 Years
STANDARD_DEVIATION 7.29 • n=22 Participants
|
27.0 Years
STANDARD_DEVIATION NA • n=23 Participants
|
36.5 Years
STANDARD_DEVIATION 10.37 • n=22 Participants
|
38.0 Years
STANDARD_DEVIATION 8.44 • n=178 Participants
|
31.8 Years
STANDARD_DEVIATION 5.91 • n=116 Participants
|
32.8 Years
STANDARD_DEVIATION 8.18 • n=2 Participants
|
32.7 Years
STANDARD_DEVIATION 7.76 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
4 Participants
n=265 Participants
|
5 Participants
n=568 Participants
|
2 Participants
n=22 Participants
|
1 Participants
n=23 Participants
|
5 Participants
n=22 Participants
|
1 Participants
n=178 Participants
|
2 Participants
n=116 Participants
|
3 Participants
n=2 Participants
|
31 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
2 Participants
n=265 Participants
|
1 Participants
n=568 Participants
|
5 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
1 Participants
n=22 Participants
|
5 Participants
n=178 Participants
|
4 Participants
n=116 Participants
|
3 Participants
n=2 Participants
|
31 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
2 Participants
n=22 Participants
|
0 Participants
n=178 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=2 Participants
|
5 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=9 Participants
|
5 Participants
n=27 Participants
|
5 Participants
n=267 Participants
|
5 Participants
n=265 Participants
|
6 Participants
n=568 Participants
|
7 Participants
n=22 Participants
|
1 Participants
n=23 Participants
|
4 Participants
n=22 Participants
|
6 Participants
n=178 Participants
|
6 Participants
n=116 Participants
|
6 Participants
n=2 Participants
|
57 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=178 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=178 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
1 Participants
n=568 Participants
|
1 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
4 Participants
n=22 Participants
|
0 Participants
n=178 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=2 Participants
|
10 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=178 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
2 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
3 Participants
n=178 Participants
|
1 Participants
n=116 Participants
|
3 Participants
n=2 Participants
|
11 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
6 Participants
n=265 Participants
|
1 Participants
n=568 Participants
|
6 Participants
n=22 Participants
|
1 Participants
n=23 Participants
|
1 Participants
n=22 Participants
|
3 Participants
n=178 Participants
|
5 Participants
n=116 Participants
|
3 Participants
n=2 Participants
|
34 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
2 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=178 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=2 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
1 Participants
n=22 Participants
|
0 Participants
n=178 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 7 post dosePopulation: Safety Population receiving MAM01 SC dose.
Solicited AEs were defined events participants were specifically asked about, which were recorded by participants in the memory aid card. Solicited AES included local injection site AEs (pain, redness, swelling, itching and bruising) and systemic AEs (fever, chills, headache, fatigue, nausea, muscle pain and joint pain). A Solicited AE does not necessarily have a causal relationship with the intervention.
Outcome measures
| Measure |
Part A (SAD Cohort 3): Repeat Dose MAM01 5 mg/kg SC
n=5 Participants
Participants received a second dose of MAM01 5 mg/kg SC following CHMI, regardless of the initial randomized treatment allocation.
|
Part A (SAD Cohort 1): MAM01 1.5 mg/kg IV
n=6 Participants
Participants were randomized to receive a single IV dose of MAM01 1.5 mg/kg.
|
Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 900 mg/kg.
|
Part A (SAD Cohort 3): MAM01 5 mg/kg IV
n=5 Participants
Participants were randomized to receive single IV dose of MAM01 5 mg/kg.
|
Part A (SAD Cohort 4): MAM01 10 mg/kg IV
n=1 Participants
Participants were randomized to receive a single IV dose of MAM01 10 mg/kg.
|
Part A (SAD Cohort 5): MAM01 40 mg/kg IV
n=6 Participants
Participants were randomized to receive a single IV dose of MAM01 40 mg/kg.
|
Part B (Cohort 6, Group 1): MAM01 450 mg/kg SC
n=6 Participants
Participants were randomized to receive single SC dose of MAM01 450 mg/kg.
|
Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC
n=6 Participants
Participants were randomized to receive single SC dose of MAM01 600 mg/kg.
|
Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 600 mg/kg.
|
Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 900 mg/kg.
|
Part B: Infectivity Controls
Non-randomized participants were enrolled prior to CHMI, did not receive treatment and acted as infectivity controls.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Solicited Adverse Events (AEs) in the Subcutaneous Cohorts
Any injection site symptom
|
0 Participants
|
0 Participants
|
—
|
2 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited Adverse Events (AEs) in the Subcutaneous Cohorts
Any general body symptom
|
0 Participants
|
1 Participants
|
—
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Through Day 28 post dosePopulation: Safety Population.
In this study an unsolicited AE is any AE not captured as a solicited AE in the Memory Aid Card between Day 0 and Day 7 after MAM01 dosing, and all AEs occurring after Day 7 post dose were collected as Unsolicited AEs.
Outcome measures
| Measure |
Part A (SAD Cohort 3): Repeat Dose MAM01 5 mg/kg SC
n=6 Participants
Participants received a second dose of MAM01 5 mg/kg SC following CHMI, regardless of the initial randomized treatment allocation.
|
Part A (SAD Cohort 1): MAM01 1.5 mg/kg IV
n=6 Participants
Participants were randomized to receive a single IV dose of MAM01 1.5 mg/kg.
|
Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC
n=6 Participants
Participants were randomized to receive single SC dose of MAM01 900 mg/kg.
|
Part A (SAD Cohort 3): MAM01 5 mg/kg IV
n=6 Participants
Participants were randomized to receive single IV dose of MAM01 5 mg/kg.
|
Part A (SAD Cohort 4): MAM01 10 mg/kg IV
n=6 Participants
Participants were randomized to receive a single IV dose of MAM01 10 mg/kg.
|
Part A (SAD Cohort 5): MAM01 40 mg/kg IV
n=6 Participants
Participants were randomized to receive a single IV dose of MAM01 40 mg/kg.
|
Part B (Cohort 6, Group 1): MAM01 450 mg/kg SC
n=7 Participants
Participants were randomized to receive single SC dose of MAM01 450 mg/kg.
|
Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC
n=1 Participants
Participants were randomized to receive single SC dose of MAM01 600 mg/kg.
|
Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC
n=6 Participants
Participants were randomized to receive single SC dose of MAM01 600 mg/kg.
|
Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC
n=6 Participants
Participants were randomized to receive single SC dose of MAM01 900 mg/kg.
|
Part B: Infectivity Controls
n=6 Participants
Non-randomized participants were enrolled prior to CHMI, did not receive treatment and acted as infectivity controls.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Unsolicited Adverse Events
|
6 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
5 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Up to Day 168Population: Safety Population.
A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or is a medically significant / important event or reaction. SUSARs are AEs reported for a clinical trial participant, which is assessed by the Sponsor and or study investigator as being unexpected, serious and as having a reasonable possibility of a causal relationship with the study drug. AESIs are adverse events that the Sponsor wants to monitor closely and which require expedited reporting.
Outcome measures
| Measure |
Part A (SAD Cohort 3): Repeat Dose MAM01 5 mg/kg SC
n=6 Participants
Participants received a second dose of MAM01 5 mg/kg SC following CHMI, regardless of the initial randomized treatment allocation.
|
Part A (SAD Cohort 1): MAM01 1.5 mg/kg IV
n=6 Participants
Participants were randomized to receive a single IV dose of MAM01 1.5 mg/kg.
|
Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC
n=6 Participants
Participants were randomized to receive single SC dose of MAM01 900 mg/kg.
|
Part A (SAD Cohort 3): MAM01 5 mg/kg IV
n=6 Participants
Participants were randomized to receive single IV dose of MAM01 5 mg/kg.
|
Part A (SAD Cohort 4): MAM01 10 mg/kg IV
n=6 Participants
Participants were randomized to receive a single IV dose of MAM01 10 mg/kg.
|
Part A (SAD Cohort 5): MAM01 40 mg/kg IV
n=6 Participants
Participants were randomized to receive a single IV dose of MAM01 40 mg/kg.
|
Part B (Cohort 6, Group 1): MAM01 450 mg/kg SC
n=7 Participants
Participants were randomized to receive single SC dose of MAM01 450 mg/kg.
|
Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC
n=1 Participants
Participants were randomized to receive single SC dose of MAM01 600 mg/kg.
|
Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC
n=6 Participants
Participants were randomized to receive single SC dose of MAM01 600 mg/kg.
|
Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC
n=6 Participants
Participants were randomized to receive single SC dose of MAM01 900 mg/kg.
|
Part B: Infectivity Controls
n=6 Participants
Non-randomized participants were enrolled prior to CHMI, did not receive treatment and acted as infectivity controls.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Serious Adverse Events (SAEs) Including Suspected Unexpected Serious Adverse Reactions (SUSARs) and Adverse Events Special Interest (AESIs)
Any SAE
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Serious Adverse Events (SAEs) Including Suspected Unexpected Serious Adverse Reactions (SUSARs) and Adverse Events Special Interest (AESIs)
Any SUSAR
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Serious Adverse Events (SAEs) Including Suspected Unexpected Serious Adverse Reactions (SUSARs) and Adverse Events Special Interest (AESIs)
Any AESI
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Through Day 336Population: Safety Population.
A SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or is a medically significant / important event or reaction. SUSARs are AEs reported for a clinical trial participant, which is assessed by the Sponsor and or study investigator as being unexpected, serious and as having a reasonable possibility of a causal relationship with the study drug. AESIs are adverse events that the Sponsor wants to monitor closely and which require expedited reporting.
Outcome measures
| Measure |
Part A (SAD Cohort 3): Repeat Dose MAM01 5 mg/kg SC
n=5 Participants
Participants received a second dose of MAM01 5 mg/kg SC following CHMI, regardless of the initial randomized treatment allocation.
|
Part A (SAD Cohort 1): MAM01 1.5 mg/kg IV
n=5 Participants
Participants were randomized to receive a single IV dose of MAM01 1.5 mg/kg.
|
Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 900 mg/kg.
|
Part A (SAD Cohort 3): MAM01 5 mg/kg IV
Participants were randomized to receive single IV dose of MAM01 5 mg/kg.
|
Part A (SAD Cohort 4): MAM01 10 mg/kg IV
Participants were randomized to receive a single IV dose of MAM01 10 mg/kg.
|
Part A (SAD Cohort 5): MAM01 40 mg/kg IV
Participants were randomized to receive a single IV dose of MAM01 40 mg/kg.
|
Part B (Cohort 6, Group 1): MAM01 450 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 450 mg/kg.
|
Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 600 mg/kg.
|
Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 600 mg/kg.
|
Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 900 mg/kg.
|
Part B: Infectivity Controls
Non-randomized participants were enrolled prior to CHMI, did not receive treatment and acted as infectivity controls.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Received 2 Doses Reporting SUSARs, SAEs and AESIs
Any SAE
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Received 2 Doses Reporting SUSARs, SAEs and AESIs
Any SUSAR
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Received 2 Doses Reporting SUSARs, SAEs and AESIs
Any AESI
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Through Day 336Population: Safety Population.
Blood samples were collected for the assessment of alanine transaminase, aspartate aminotransferase, alkaline phosphatase, total carbon-dioxide (CO2), chloride, total bilirubin, creatinine, blood urea nitrogen, glucose, albumin, total protein, sodium and potassium.
Outcome measures
| Measure |
Part A (SAD Cohort 3): Repeat Dose MAM01 5 mg/kg SC
n=6 Participants
Participants received a second dose of MAM01 5 mg/kg SC following CHMI, regardless of the initial randomized treatment allocation.
|
Part A (SAD Cohort 1): MAM01 1.5 mg/kg IV
n=6 Participants
Participants were randomized to receive a single IV dose of MAM01 1.5 mg/kg.
|
Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC
n=6 Participants
Participants were randomized to receive single SC dose of MAM01 900 mg/kg.
|
Part A (SAD Cohort 3): MAM01 5 mg/kg IV
n=6 Participants
Participants were randomized to receive single IV dose of MAM01 5 mg/kg.
|
Part A (SAD Cohort 4): MAM01 10 mg/kg IV
n=6 Participants
Participants were randomized to receive a single IV dose of MAM01 10 mg/kg.
|
Part A (SAD Cohort 5): MAM01 40 mg/kg IV
n=6 Participants
Participants were randomized to receive a single IV dose of MAM01 40 mg/kg.
|
Part B (Cohort 6, Group 1): MAM01 450 mg/kg SC
n=7 Participants
Participants were randomized to receive single SC dose of MAM01 450 mg/kg.
|
Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC
n=1 Participants
Participants were randomized to receive single SC dose of MAM01 600 mg/kg.
|
Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC
n=6 Participants
Participants were randomized to receive single SC dose of MAM01 600 mg/kg.
|
Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC
n=6 Participants
Participants were randomized to receive single SC dose of MAM01 900 mg/kg.
|
Part B: Infectivity Controls
n=6 Participants
Non-randomized participants were enrolled prior to CHMI, did not receive treatment and acted as infectivity controls.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Serum Chemistry Parameters
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Through Day 336Population: Safety Population.
Blood samples were collected for the assessment of complete blood count (CBC) including hemoglobin, platelet count, and white blood cell counts, and differential to include the absolute counts for neutrophils, lymphocytes, eosinophils, and monocytes.
Outcome measures
| Measure |
Part A (SAD Cohort 3): Repeat Dose MAM01 5 mg/kg SC
n=6 Participants
Participants received a second dose of MAM01 5 mg/kg SC following CHMI, regardless of the initial randomized treatment allocation.
|
Part A (SAD Cohort 1): MAM01 1.5 mg/kg IV
n=6 Participants
Participants were randomized to receive a single IV dose of MAM01 1.5 mg/kg.
|
Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC
n=6 Participants
Participants were randomized to receive single SC dose of MAM01 900 mg/kg.
|
Part A (SAD Cohort 3): MAM01 5 mg/kg IV
n=6 Participants
Participants were randomized to receive single IV dose of MAM01 5 mg/kg.
|
Part A (SAD Cohort 4): MAM01 10 mg/kg IV
n=6 Participants
Participants were randomized to receive a single IV dose of MAM01 10 mg/kg.
|
Part A (SAD Cohort 5): MAM01 40 mg/kg IV
n=6 Participants
Participants were randomized to receive a single IV dose of MAM01 40 mg/kg.
|
Part B (Cohort 6, Group 1): MAM01 450 mg/kg SC
n=7 Participants
Participants were randomized to receive single SC dose of MAM01 450 mg/kg.
|
Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC
n=1 Participants
Participants were randomized to receive single SC dose of MAM01 600 mg/kg.
|
Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC
n=6 Participants
Participants were randomized to receive single SC dose of MAM01 600 mg/kg.
|
Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC
n=6 Participants
Participants were randomized to receive single SC dose of MAM01 900 mg/kg.
|
Part B: Infectivity Controls
n=6 Participants
Non-randomized participants were enrolled prior to CHMI, did not receive treatment and acted as infectivity controls.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Hematology Parameters
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Pre-dose, Day 0: end of infusion (EOI), 1, 3 and 6 hours; Day 1: 24 hours; Day 2: 48 hours; Days 7, 14, 28, 42, 56, 70, 84, 98, 112, 140, 168, 224 and 280 post-dosePopulation: Pharmacokinetic Population comprised of all participants who were randomly assigned to trial intervention, received the trial intervention, and have baseline and on-study concentration-time data available.
Serum from venous blood samples was collected for measurement of MAM01 pharmacokinetics.
Outcome measures
| Measure |
Part A (SAD Cohort 3): Repeat Dose MAM01 5 mg/kg SC
n=6 Participants
Participants received a second dose of MAM01 5 mg/kg SC following CHMI, regardless of the initial randomized treatment allocation.
|
Part A (SAD Cohort 1): MAM01 1.5 mg/kg IV
n=6 Participants
Participants were randomized to receive a single IV dose of MAM01 1.5 mg/kg.
|
Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC
n=6 Participants
Participants were randomized to receive single SC dose of MAM01 900 mg/kg.
|
Part A (SAD Cohort 3): MAM01 5 mg/kg IV
n=6 Participants
Participants were randomized to receive single IV dose of MAM01 5 mg/kg.
|
Part A (SAD Cohort 4): MAM01 10 mg/kg IV
n=6 Participants
Participants were randomized to receive a single IV dose of MAM01 10 mg/kg.
|
Part A (SAD Cohort 5): MAM01 40 mg/kg IV
n=6 Participants
Participants were randomized to receive a single IV dose of MAM01 40 mg/kg.
|
Part B (Cohort 6, Group 1): MAM01 450 mg/kg SC
n=6 Participants
Participants were randomized to receive single SC dose of MAM01 450 mg/kg.
|
Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC
n=6 Participants
Participants were randomized to receive single SC dose of MAM01 600 mg/kg.
|
Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 600 mg/kg.
|
Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 900 mg/kg.
|
Part B: Infectivity Controls
Non-randomized participants were enrolled prior to CHMI, did not receive treatment and acted as infectivity controls.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximal Observed Concentration (Cmax) Following Single Dose of MAM01
|
33.1 micrograms per milliliter
Geometric Coefficient of Variation 30.8
|
19.5 micrograms per milliliter
Geometric Coefficient of Variation 13.9
|
95.6 micrograms per milliliter
Geometric Coefficient of Variation 25.6
|
58.1 micrograms per milliliter
Geometric Coefficient of Variation 8.6
|
122 micrograms per milliliter
Geometric Coefficient of Variation 15.7
|
513 micrograms per milliliter
Geometric Coefficient of Variation 10.0
|
46.0 micrograms per milliliter
Geometric Coefficient of Variation 18.5
|
62.7 micrograms per milliliter
Geometric Coefficient of Variation 8.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, Day 0: end of infusion (EOI), 1, 3 and 6 hours, Day 1: 24 hours, Day 2: 48 hours, Days 7, 14, 28, 42, 56, 70, 84, 98, 112, 140, 168, 224 and 280 post-dosePopulation: Pharmacokinetic Population.
Serum from venous blood samples was collected for measurement of MAM01 pharmacokinetics.
Outcome measures
| Measure |
Part A (SAD Cohort 3): Repeat Dose MAM01 5 mg/kg SC
n=5 Participants
Participants received a second dose of MAM01 5 mg/kg SC following CHMI, regardless of the initial randomized treatment allocation.
|
Part A (SAD Cohort 1): MAM01 1.5 mg/kg IV
n=5 Participants
Participants were randomized to receive a single IV dose of MAM01 1.5 mg/kg.
|
Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 900 mg/kg.
|
Part A (SAD Cohort 3): MAM01 5 mg/kg IV
Participants were randomized to receive single IV dose of MAM01 5 mg/kg.
|
Part A (SAD Cohort 4): MAM01 10 mg/kg IV
Participants were randomized to receive a single IV dose of MAM01 10 mg/kg.
|
Part A (SAD Cohort 5): MAM01 40 mg/kg IV
Participants were randomized to receive a single IV dose of MAM01 40 mg/kg.
|
Part B (Cohort 6, Group 1): MAM01 450 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 450 mg/kg.
|
Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 600 mg/kg.
|
Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 600 mg/kg.
|
Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 900 mg/kg.
|
Part B: Infectivity Controls
Non-randomized participants were enrolled prior to CHMI, did not receive treatment and acted as infectivity controls.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax Following Repeat Dosing of MAM01
|
40.4 micrograms per milliliter
Geometric Coefficient of Variation 9.0
|
42.8 micrograms per milliliter
Geometric Coefficient of Variation 4.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, Day 0: end of infusion (EOI), 1, 3 and 6 hours; Day 1: 24 hours; Day 2: 48 hours; Days 7, 14, 28, 42, 56, 70, 84, 98, 112, 140, 168, 224 and 280 post-dosePopulation: Pharmacokinetic Population.
Serum from venous blood samples was collected for measurement of MAM01 pharmacokinetics.
Outcome measures
| Measure |
Part A (SAD Cohort 3): Repeat Dose MAM01 5 mg/kg SC
n=6 Participants
Participants received a second dose of MAM01 5 mg/kg SC following CHMI, regardless of the initial randomized treatment allocation.
|
Part A (SAD Cohort 1): MAM01 1.5 mg/kg IV
n=6 Participants
Participants were randomized to receive a single IV dose of MAM01 1.5 mg/kg.
|
Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC
n=6 Participants
Participants were randomized to receive single SC dose of MAM01 900 mg/kg.
|
Part A (SAD Cohort 3): MAM01 5 mg/kg IV
n=6 Participants
Participants were randomized to receive single IV dose of MAM01 5 mg/kg.
|
Part A (SAD Cohort 4): MAM01 10 mg/kg IV
n=6 Participants
Participants were randomized to receive a single IV dose of MAM01 10 mg/kg.
|
Part A (SAD Cohort 5): MAM01 40 mg/kg IV
n=6 Participants
Participants were randomized to receive a single IV dose of MAM01 40 mg/kg.
|
Part B (Cohort 6, Group 1): MAM01 450 mg/kg SC
n=6 Participants
Participants were randomized to receive single SC dose of MAM01 450 mg/kg.
|
Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC
n=6 Participants
Participants were randomized to receive single SC dose of MAM01 600 mg/kg.
|
Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 600 mg/kg.
|
Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 900 mg/kg.
|
Part B: Infectivity Controls
Non-randomized participants were enrolled prior to CHMI, did not receive treatment and acted as infectivity controls.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Curve (AUC) From Time=0 to the Last Measurable Concentration (AUC0-t) Following Single Dose of MAM01
|
3154.5 day*micrograms per milliliter
Geometric Coefficient of Variation 35.1
|
1448.7 day*micrograms per milliliter
Geometric Coefficient of Variation 22.6
|
6018.7 day*micrograms per milliliter
Geometric Coefficient of Variation 22.0
|
5054.9 day*micrograms per milliliter
Geometric Coefficient of Variation 18.1
|
10997.7 day*micrograms per milliliter
Geometric Coefficient of Variation 17.5
|
43082.1 day*micrograms per milliliter
Geometric Coefficient of Variation 14.7
|
2734.4 day*micrograms per milliliter
Geometric Coefficient of Variation 24.0
|
3408.6 day*micrograms per milliliter
Geometric Coefficient of Variation 31.7
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, Day 0: end of infusion (EOI), 1, 3 and 6 hours; Day 1: 24 hours; Day 2: 48 hours; Days 7, 14, 28, 42, 56, 70, 84, 98, 112, 140, 168, 224 and 280 post-dosePopulation: Pharmacokinetic Population.
Serum from venous blood samples was collected for measurement of MAM01 pharmacokinetics.
Outcome measures
| Measure |
Part A (SAD Cohort 3): Repeat Dose MAM01 5 mg/kg SC
n=5 Participants
Participants received a second dose of MAM01 5 mg/kg SC following CHMI, regardless of the initial randomized treatment allocation.
|
Part A (SAD Cohort 1): MAM01 1.5 mg/kg IV
n=5 Participants
Participants were randomized to receive a single IV dose of MAM01 1.5 mg/kg.
|
Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 900 mg/kg.
|
Part A (SAD Cohort 3): MAM01 5 mg/kg IV
Participants were randomized to receive single IV dose of MAM01 5 mg/kg.
|
Part A (SAD Cohort 4): MAM01 10 mg/kg IV
Participants were randomized to receive a single IV dose of MAM01 10 mg/kg.
|
Part A (SAD Cohort 5): MAM01 40 mg/kg IV
Participants were randomized to receive a single IV dose of MAM01 40 mg/kg.
|
Part B (Cohort 6, Group 1): MAM01 450 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 450 mg/kg.
|
Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 600 mg/kg.
|
Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 600 mg/kg.
|
Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 900 mg/kg.
|
Part B: Infectivity Controls
Non-randomized participants were enrolled prior to CHMI, did not receive treatment and acted as infectivity controls.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC (0-t) Following Repeat Dosing of MAM01
|
4082.9 day*micrograms per milliliter
Geometric Coefficient of Variation 15.7
|
4008.3 day*micrograms per milliliter
Geometric Coefficient of Variation 14.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, Day 0: end of infusion (EOI), 1, 3 and 6 hours; Day 1: 24 hours; Day 2: 48 hours; Days 7, 14, 28, 42, 56, 70, 84, 98, 112, 140, 168, 224 and 280 post-dosePopulation: Pharmacokinetic Population. Only those participants with data available at specified timepoints has been presented.
Serum from venous blood samples was collected for measurement of MAM01 pharmacokinetics.
Outcome measures
| Measure |
Part A (SAD Cohort 3): Repeat Dose MAM01 5 mg/kg SC
n=6 Participants
Participants received a second dose of MAM01 5 mg/kg SC following CHMI, regardless of the initial randomized treatment allocation.
|
Part A (SAD Cohort 1): MAM01 1.5 mg/kg IV
n=4 Participants
Participants were randomized to receive a single IV dose of MAM01 1.5 mg/kg.
|
Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC
n=6 Participants
Participants were randomized to receive single SC dose of MAM01 900 mg/kg.
|
Part A (SAD Cohort 3): MAM01 5 mg/kg IV
n=5 Participants
Participants were randomized to receive single IV dose of MAM01 5 mg/kg.
|
Part A (SAD Cohort 4): MAM01 10 mg/kg IV
n=6 Participants
Participants were randomized to receive a single IV dose of MAM01 10 mg/kg.
|
Part A (SAD Cohort 5): MAM01 40 mg/kg IV
n=3 Participants
Participants were randomized to receive a single IV dose of MAM01 40 mg/kg.
|
Part B (Cohort 6, Group 1): MAM01 450 mg/kg SC
n=6 Participants
Participants were randomized to receive single SC dose of MAM01 450 mg/kg.
|
Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC
n=6 Participants
Participants were randomized to receive single SC dose of MAM01 600 mg/kg.
|
Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 600 mg/kg.
|
Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 900 mg/kg.
|
Part B: Infectivity Controls
Non-randomized participants were enrolled prior to CHMI, did not receive treatment and acted as infectivity controls.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Partial AUC's Time= 0 to the CHMI Challenge (AUC0-CHMI) of MAM01
|
2962.8 day*micrograms per milliliter
Geometric Coefficient of Variation 32.0
|
1481.4 day*micrograms per milliliter
Geometric Coefficient of Variation 10.0
|
2771.4 day*micrograms per milliliter
Geometric Coefficient of Variation 23.2
|
4503.9 day*micrograms per milliliter
Geometric Coefficient of Variation 18.0
|
9197.7 day*micrograms per milliliter
Geometric Coefficient of Variation 17.1
|
31934.1 day*micrograms per milliliter
Geometric Coefficient of Variation 15.1
|
1323.4 day*micrograms per milliliter
Geometric Coefficient of Variation 18.9
|
1658.4 day*micrograms per milliliter
Geometric Coefficient of Variation 15.6
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, Day 0: end of infusion (EOI), 1, 3 and 6 hours; Day 1: 24 hours; Day 2: 48 hours; Days 7, 14, 28, 42, 56, 70, 84, 98, 112, 140, 168, 224 and 280 post-dosePopulation: Pharmacokinetic Population. Only participants with data available at the specified timepoints have been presented.
Serum from venous blood samples was collected for measurement of MAM01 pharmacokinetics.
Outcome measures
| Measure |
Part A (SAD Cohort 3): Repeat Dose MAM01 5 mg/kg SC
n=6 Participants
Participants received a second dose of MAM01 5 mg/kg SC following CHMI, regardless of the initial randomized treatment allocation.
|
Part A (SAD Cohort 1): MAM01 1.5 mg/kg IV
n=4 Participants
Participants were randomized to receive a single IV dose of MAM01 1.5 mg/kg.
|
Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC
n=6 Participants
Participants were randomized to receive single SC dose of MAM01 900 mg/kg.
|
Part A (SAD Cohort 3): MAM01 5 mg/kg IV
n=5 Participants
Participants were randomized to receive single IV dose of MAM01 5 mg/kg.
|
Part A (SAD Cohort 4): MAM01 10 mg/kg IV
n=6 Participants
Participants were randomized to receive a single IV dose of MAM01 10 mg/kg.
|
Part A (SAD Cohort 5): MAM01 40 mg/kg IV
n=3 Participants
Participants were randomized to receive a single IV dose of MAM01 40 mg/kg.
|
Part B (Cohort 6, Group 1): MAM01 450 mg/kg SC
n=6 Participants
Participants were randomized to receive single SC dose of MAM01 450 mg/kg.
|
Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC
n=6 Participants
Participants were randomized to receive single SC dose of MAM01 600 mg/kg.
|
Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 600 mg/kg.
|
Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 900 mg/kg.
|
Part B: Infectivity Controls
Non-randomized participants were enrolled prior to CHMI, did not receive treatment and acted as infectivity controls.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Concentration at the Time of CHMI (CCHMI) of MAM01
|
7.00 micrograms per milliliter
Geometric Coefficient of Variation 39.4
|
3.02 micrograms per milliliter
Geometric Coefficient of Variation 15.4
|
77.3 micrograms per milliliter
Geometric Coefficient of Variation 20.4
|
13.2 micrograms per milliliter
Geometric Coefficient of Variation 34.9
|
31.2 micrograms per milliliter
Geometric Coefficient of Variation 23.3
|
119 micrograms per milliliter
Geometric Coefficient of Variation 30.8
|
36.0 micrograms per milliliter
Geometric Coefficient of Variation 18.3
|
40.3 micrograms per milliliter
Geometric Coefficient of Variation 45.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, Day 0: end of infusion (EOI), 1, 3 and 6 hours; Day 1: 24 hours; Day 2: 48 hours; Days 7, 14, 28, 42, 56, 70, 84, 98, 112, 140, 168, 224 and 280 post-dosePopulation: Pharmacokinetic Population.
Serum from venous blood samples was collected for measurement of MAM01 pharmacokinetics.
Outcome measures
| Measure |
Part A (SAD Cohort 3): Repeat Dose MAM01 5 mg/kg SC
n=6 Participants
Participants received a second dose of MAM01 5 mg/kg SC following CHMI, regardless of the initial randomized treatment allocation.
|
Part A (SAD Cohort 1): MAM01 1.5 mg/kg IV
n=6 Participants
Participants were randomized to receive a single IV dose of MAM01 1.5 mg/kg.
|
Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC
n=6 Participants
Participants were randomized to receive single SC dose of MAM01 900 mg/kg.
|
Part A (SAD Cohort 3): MAM01 5 mg/kg IV
n=6 Participants
Participants were randomized to receive single IV dose of MAM01 5 mg/kg.
|
Part A (SAD Cohort 4): MAM01 10 mg/kg IV
n=6 Participants
Participants were randomized to receive a single IV dose of MAM01 10 mg/kg.
|
Part A (SAD Cohort 5): MAM01 40 mg/kg IV
n=6 Participants
Participants were randomized to receive a single IV dose of MAM01 40 mg/kg.
|
Part B (Cohort 6, Group 1): MAM01 450 mg/kg SC
n=6 Participants
Participants were randomized to receive single SC dose of MAM01 450 mg/kg.
|
Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC
n=6 Participants
Participants were randomized to receive single SC dose of MAM01 600 mg/kg.
|
Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 600 mg/kg.
|
Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 900 mg/kg.
|
Part B: Infectivity Controls
Non-randomized participants were enrolled prior to CHMI, did not receive treatment and acted as infectivity controls.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood Terminal Elimination Rate Constant (λz) of MAM01
|
NA 1/day
Geometric Coefficient of Variation NA
Geometric mean and geometric coefficient of variance could not be calculated for λz as the total AUC was extrapolated greater than 20% (beyond the last measurable concentration)
|
NA 1/day
Geometric Coefficient of Variation NA
Geometric mean and geometric coefficient of variance could not be calculated for λz as the total AUC was extrapolated greater than 20% (beyond the last measurable concentration)
|
NA 1/day
Geometric Coefficient of Variation NA
Geometric mean and geometric coefficient of variance could not be calculated for λz as the total AUC was extrapolated greater than 20% (beyond the last measurable concentration)
|
NA 1/day
Geometric Coefficient of Variation NA
Geometric mean and geometric coefficient of variance could not be calculated for λz as the total AUC was extrapolated greater than 20% (beyond the last measurable concentration)
|
NA 1/day
Geometric Coefficient of Variation NA
Geometric mean and geometric coefficient of variance could not be calculated for λz as the total AUC was extrapolated greater than 20% (beyond the last measurable concentration)
|
NA 1/day
Geometric Coefficient of Variation NA
Geometric mean and geometric coefficient of variance could not be calculated for λz as the total AUC was extrapolated greater than 20% (beyond the last measurable concentration)
|
NA 1/day
Geometric Coefficient of Variation NA
Geometric mean and geometric coefficient of variance could not be calculated for λz as the total AUC was extrapolated greater than 20% (beyond the last measurable concentration)
|
NA 1/day
Geometric Coefficient of Variation NA
Geometric mean and geometric coefficient of variance could not be calculated for λz as the total AUC was extrapolated greater than 20% (beyond the last measurable concentration)
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Time Frame: Pre-dose, Day 0: end of infusion (EOI), 1, 3 and 6 hours; Day 1: 24 hours; Day 2: 48 hours; Days 7, 14, 28, 42, 56, 70, 84, 98, 112, 140, 168, 224 and 280 post-dosePopulation: Pharmacokinetic Population. Only participants with data available at the specified timepoints have been presented.
Serum from venous blood samples was collected for measurement of MAM01 pharmacokinetics.
Outcome measures
| Measure |
Part A (SAD Cohort 3): Repeat Dose MAM01 5 mg/kg SC
n=5 Participants
Participants received a second dose of MAM01 5 mg/kg SC following CHMI, regardless of the initial randomized treatment allocation.
|
Part A (SAD Cohort 1): MAM01 1.5 mg/kg IV
n=5 Participants
Participants were randomized to receive a single IV dose of MAM01 1.5 mg/kg.
|
Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 900 mg/kg.
|
Part A (SAD Cohort 3): MAM01 5 mg/kg IV
n=3 Participants
Participants were randomized to receive single IV dose of MAM01 5 mg/kg.
|
Part A (SAD Cohort 4): MAM01 10 mg/kg IV
n=6 Participants
Participants were randomized to receive a single IV dose of MAM01 10 mg/kg.
|
Part A (SAD Cohort 5): MAM01 40 mg/kg IV
n=6 Participants
Participants were randomized to receive a single IV dose of MAM01 40 mg/kg.
|
Part B (Cohort 6, Group 1): MAM01 450 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 450 mg/kg.
|
Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC
n=1 Participants
Participants were randomized to receive single SC dose of MAM01 600 mg/kg.
|
Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 600 mg/kg.
|
Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 900 mg/kg.
|
Part B: Infectivity Controls
Non-randomized participants were enrolled prior to CHMI, did not receive treatment and acted as infectivity controls.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Terminal Half Life (t1/2) Following Single Dose of MAM01
|
68.1 Days
Geometric Coefficient of Variation 14.9
|
70.7 Days
Geometric Coefficient of Variation 9.3
|
—
|
74.3 Days
Geometric Coefficient of Variation 15.5
|
70.7 Days
Geometric Coefficient of Variation 12.5
|
71.7 Days
Geometric Coefficient of Variation 17.0
|
—
|
NA Days
Geometric Coefficient of Variation NA
Geometric mean and Geometric coefficient of variance could not be calculated due to study design factors and limited sample size.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, Day 0: end of infusion (EOI), 1, 3 and 6 hours; Day 1: 24 hours; Day 2: 48 hours; Days 7, 14, 28, 42, 56, 70, 84, 98, 112, 140, 168, 224 and 280 post-dosePopulation: Pharmacokinetic Population. Only those participants with data available at specified timepoints has been presented.
Serum from venous blood samples was collected for measurement of MAM01 pharmacokinetics.
Outcome measures
| Measure |
Part A (SAD Cohort 3): Repeat Dose MAM01 5 mg/kg SC
n=2 Participants
Participants received a second dose of MAM01 5 mg/kg SC following CHMI, regardless of the initial randomized treatment allocation.
|
Part A (SAD Cohort 1): MAM01 1.5 mg/kg IV
n=2 Participants
Participants were randomized to receive a single IV dose of MAM01 1.5 mg/kg.
|
Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 900 mg/kg.
|
Part A (SAD Cohort 3): MAM01 5 mg/kg IV
Participants were randomized to receive single IV dose of MAM01 5 mg/kg.
|
Part A (SAD Cohort 4): MAM01 10 mg/kg IV
Participants were randomized to receive a single IV dose of MAM01 10 mg/kg.
|
Part A (SAD Cohort 5): MAM01 40 mg/kg IV
Participants were randomized to receive a single IV dose of MAM01 40 mg/kg.
|
Part B (Cohort 6, Group 1): MAM01 450 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 450 mg/kg.
|
Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 600 mg/kg.
|
Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 600 mg/kg.
|
Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 900 mg/kg.
|
Part B: Infectivity Controls
Non-randomized participants were enrolled prior to CHMI, did not receive treatment and acted as infectivity controls.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
t1/2 Following Repeat Dosing of MAM01
|
56.0 Days
Geometric Coefficient of Variation 3.0
|
67.2 Days
Geometric Coefficient of Variation 0.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, Day 0: end of infusion (EOI), 1, 3 and 6 hours; Day 1: 24 hours; Day 2: 48 hours; Days 7, 14, 28, 42, 56, 70, 84, 98, 112, 140, 168, 224 and 280 post-dosePopulation: Pharmacokinetic Population
Serum from venous blood samples was collected for measurement of MAM01 pharmacokinetics.
Outcome measures
| Measure |
Part A (SAD Cohort 3): Repeat Dose MAM01 5 mg/kg SC
n=5 Participants
Participants received a second dose of MAM01 5 mg/kg SC following CHMI, regardless of the initial randomized treatment allocation.
|
Part A (SAD Cohort 1): MAM01 1.5 mg/kg IV
n=5 Participants
Participants were randomized to receive a single IV dose of MAM01 1.5 mg/kg.
|
Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 900 mg/kg.
|
Part A (SAD Cohort 3): MAM01 5 mg/kg IV
n=3 Participants
Participants were randomized to receive single IV dose of MAM01 5 mg/kg.
|
Part A (SAD Cohort 4): MAM01 10 mg/kg IV
n=6 Participants
Participants were randomized to receive a single IV dose of MAM01 10 mg/kg.
|
Part A (SAD Cohort 5): MAM01 40 mg/kg IV
n=6 Participants
Participants were randomized to receive a single IV dose of MAM01 40 mg/kg.
|
Part B (Cohort 6, Group 1): MAM01 450 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 450 mg/kg.
|
Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC
n=1 Participants
Participants were randomized to receive single SC dose of MAM01 600 mg/kg.
|
Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 600 mg/kg.
|
Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 900 mg/kg.
|
Part B: Infectivity Controls
Non-randomized participants were enrolled prior to CHMI, did not receive treatment and acted as infectivity controls.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC From Time=0 Extrapolated to Infinity (AUC0-infinity) of MAM01
|
3738 day*micrograms per milliliter
Geometric Coefficient of Variation 38.6
|
1781 day*micrograms per milliliter
Geometric Coefficient of Variation 10.8
|
—
|
5335 day*micrograms per milliliter
Geometric Coefficient of Variation 20.0
|
12467 day*micrograms per milliliter
Geometric Coefficient of Variation 19.2
|
49011 day*micrograms per milliliter
Geometric Coefficient of Variation 17.7
|
—
|
NA day*micrograms per milliliter
Geometric Coefficient of Variation NA
Geometric mean and geometric coefficient of variance could not be calculated due to study design factors and limited sample size.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, Day 0: end of infusion (EOI), 1, 3 and 6 hours; Day 1: 24 hours; Day 2: 48 hours; Days 7, 14, 28, 42, 56, 70, 84, 98, 112, 140, 168, 224, 280 and 378 post-dosePopulation: Pharmacokinetic Population.
Serum from venous blood samples was collected for measurement of MAM01 pharmacokinetics.
Outcome measures
| Measure |
Part A (SAD Cohort 3): Repeat Dose MAM01 5 mg/kg SC
n=5 Participants
Participants received a second dose of MAM01 5 mg/kg SC following CHMI, regardless of the initial randomized treatment allocation.
|
Part A (SAD Cohort 1): MAM01 1.5 mg/kg IV
n=5 Participants
Participants were randomized to receive a single IV dose of MAM01 1.5 mg/kg.
|
Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 900 mg/kg.
|
Part A (SAD Cohort 3): MAM01 5 mg/kg IV
Participants were randomized to receive single IV dose of MAM01 5 mg/kg.
|
Part A (SAD Cohort 4): MAM01 10 mg/kg IV
Participants were randomized to receive a single IV dose of MAM01 10 mg/kg.
|
Part A (SAD Cohort 5): MAM01 40 mg/kg IV
Participants were randomized to receive a single IV dose of MAM01 40 mg/kg.
|
Part B (Cohort 6, Group 1): MAM01 450 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 450 mg/kg.
|
Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 600 mg/kg.
|
Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 600 mg/kg.
|
Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 900 mg/kg.
|
Part B: Infectivity Controls
Non-randomized participants were enrolled prior to CHMI, did not receive treatment and acted as infectivity controls.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Absolute Bioavailability of SC Formulation Following Repeated Dosing of MAM01
|
0.692 Unitless
Geometric Coefficient of Variation 13.6
|
NA Unitless
Geometric Coefficient of Variation NA
Data was not available as all concentration values were below the lower limit of quantification
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, Day 0: end of infusion (EOI), 1, 3 and 6 hours; Day 1: 24 hours; Day 2: 48 hours; Days 7, 14, 28, 42, 56, 70, 84, 98, 112, 140 and 168 post-dosePopulation: Pharmacokinetic Population. Only participants with data available at the specified timepoints have been presented.
Serum from venous blood samples was collected for measurement of MAM01 pharmacokinetics. The accumulation ratio was calculated as the ratio of AUC (0-168) (post first dose) to AUC (210-378) (post redose).
Outcome measures
| Measure |
Part A (SAD Cohort 3): Repeat Dose MAM01 5 mg/kg SC
n=5 Participants
Participants received a second dose of MAM01 5 mg/kg SC following CHMI, regardless of the initial randomized treatment allocation.
|
Part A (SAD Cohort 1): MAM01 1.5 mg/kg IV
n=4 Participants
Participants were randomized to receive a single IV dose of MAM01 1.5 mg/kg.
|
Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 900 mg/kg.
|
Part A (SAD Cohort 3): MAM01 5 mg/kg IV
Participants were randomized to receive single IV dose of MAM01 5 mg/kg.
|
Part A (SAD Cohort 4): MAM01 10 mg/kg IV
Participants were randomized to receive a single IV dose of MAM01 10 mg/kg.
|
Part A (SAD Cohort 5): MAM01 40 mg/kg IV
Participants were randomized to receive a single IV dose of MAM01 40 mg/kg.
|
Part B (Cohort 6, Group 1): MAM01 450 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 450 mg/kg.
|
Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 600 mg/kg.
|
Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 600 mg/kg.
|
Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 900 mg/kg.
|
Part B: Infectivity Controls
Non-randomized participants were enrolled prior to CHMI, did not receive treatment and acted as infectivity controls.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Accumulation Ratio (AUC0-168) Following Repeated Doses of MAM01
|
NA Ratio
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation could not be calculated due to high proportion of non-quantifiable values (\>30% of values were imputed).
|
1.29 Ratio
Geometric Coefficient of Variation 15.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 27 post-CHMIPopulation: Efficacy Population. Only participants with data available at the specified timepoints have been presented.
The characterization of protective efficacy against Pf following CHMI challenge, was assessed by evaluating the presence or absence of Pf infection as determined by qRT-PCR after CHMI (planned through 4 weeks post-CHMI) and evaluating the time to parasitemia after CHMI in each cohort.
Outcome measures
| Measure |
Part A (SAD Cohort 3): Repeat Dose MAM01 5 mg/kg SC
n=6 Participants
Participants received a second dose of MAM01 5 mg/kg SC following CHMI, regardless of the initial randomized treatment allocation.
|
Part A (SAD Cohort 1): MAM01 1.5 mg/kg IV
n=3 Participants
Participants were randomized to receive a single IV dose of MAM01 1.5 mg/kg.
|
Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC
n=5 Participants
Participants were randomized to receive single SC dose of MAM01 900 mg/kg.
|
Part A (SAD Cohort 3): MAM01 5 mg/kg IV
n=5 Participants
Participants were randomized to receive single IV dose of MAM01 5 mg/kg.
|
Part A (SAD Cohort 4): MAM01 10 mg/kg IV
n=5 Participants
Participants were randomized to receive a single IV dose of MAM01 10 mg/kg.
|
Part A (SAD Cohort 5): MAM01 40 mg/kg IV
n=3 Participants
Participants were randomized to receive a single IV dose of MAM01 40 mg/kg.
|
Part B (Cohort 6, Group 1): MAM01 450 mg/kg SC
n=5 Participants
Participants were randomized to receive single SC dose of MAM01 450 mg/kg.
|
Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC
n=1 Participants
Participants were randomized to receive single SC dose of MAM01 600 mg/kg.
|
Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC
n=6 Participants
Participants were randomized to receive single SC dose of MAM01 600 mg/kg.
|
Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC
n=6 Participants
Participants were randomized to receive single SC dose of MAM01 900 mg/kg.
|
Part B: Infectivity Controls
n=6 Participants
Non-randomized participants were enrolled prior to CHMI, did not receive treatment and acted as infectivity controls.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Confirmed Pf Infection Assessed by Quantitative Polymerase Chain Reaction Assay (qRT-PCR) After CHMI
|
5 Participants
|
3 Participants
|
4 Participants
|
5 Participants
|
5 Participants
|
0 Participants
|
5 Participants
|
1 Participants
|
6 Participants
|
4 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Up to Day 27 post-CHMIPopulation: Efficacy Population. Only participants with data available at the specified timepoints have been presented.
Parasitemia was assessed by qRT-PCR up to Day 27 following CHMI. In addition, a thick blood smear was prepared for microscopic analysis, which was examined only once the first qRT-PCR sample tested positive. Daily parasitemia monitoring continued until the participant had a confirmed initial positive qRT-PCR. The first positive qRT-PCR triggered either a second PCR test or microscopic analysis of the blood smear. Once two positive results were obtained, rescue therapy was initiated.
Outcome measures
| Measure |
Part A (SAD Cohort 3): Repeat Dose MAM01 5 mg/kg SC
n=6 Participants
Participants received a second dose of MAM01 5 mg/kg SC following CHMI, regardless of the initial randomized treatment allocation.
|
Part A (SAD Cohort 1): MAM01 1.5 mg/kg IV
n=3 Participants
Participants were randomized to receive a single IV dose of MAM01 1.5 mg/kg.
|
Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC
n=5 Participants
Participants were randomized to receive single SC dose of MAM01 900 mg/kg.
|
Part A (SAD Cohort 3): MAM01 5 mg/kg IV
n=5 Participants
Participants were randomized to receive single IV dose of MAM01 5 mg/kg.
|
Part A (SAD Cohort 4): MAM01 10 mg/kg IV
n=5 Participants
Participants were randomized to receive a single IV dose of MAM01 10 mg/kg.
|
Part A (SAD Cohort 5): MAM01 40 mg/kg IV
n=3 Participants
Participants were randomized to receive a single IV dose of MAM01 40 mg/kg.
|
Part B (Cohort 6, Group 1): MAM01 450 mg/kg SC
n=5 Participants
Participants were randomized to receive single SC dose of MAM01 450 mg/kg.
|
Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC
n=1 Participants
Participants were randomized to receive single SC dose of MAM01 600 mg/kg.
|
Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC
n=6 Participants
Participants were randomized to receive single SC dose of MAM01 600 mg/kg.
|
Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC
n=6 Participants
Participants were randomized to receive single SC dose of MAM01 900 mg/kg.
|
Part B: Infectivity Controls
n=6 Participants
Non-randomized participants were enrolled prior to CHMI, did not receive treatment and acted as infectivity controls.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Parasitemia After CHMI
|
7 Days
Interval 7.0 to 10.0
|
9 Days
Interval 7.0 to 11.0
|
9 Days
Interval 7.0 to
The insufficient number of participants with events and narrow spread of event times prevented estimation of upper bounds for the confidence interval.
|
9 Days
Interval 9.0 to 11.0
|
10 Days
Interval 8.0 to 11.0
|
NA Days
No Cohort 5 participants experienced parasitemia, therefore a median value and confidence intervals for "Time to Parasitemia after CHMI" are not available.
|
7 Days
Interval 7.0 to 7.0
|
7 Days
Participant became parasitemic on Day 7; as there was only 1 Part A Infectivity Control participant, the median (7) is estimable, but confidence intervals are not calculable due to lack of variability in event times (i.e., insufficient number of participants to calculate confidence intervals).
|
8 Days
The insufficient number of participants with events and narrow spread of event times prevented estimation of upper and lower bounds for the confidence interval.
|
9.5 Days
Interval 9.0 to
The insufficient number of participants with events and narrow spread of event times prevented estimation of upper bounds for the confidence interval.
|
7 Days
Participant became parasitemic on Day 7; as there was only 1 Part A Infectivity Control participant, the median (7) is estimable, but confidence intervals are not calculable due to lack of variability in event times (i.e., insufficient number of participants to calculate confidence intervals).
|
SECONDARY outcome
Timeframe: Up to Day 280Population: Immunogenicity Population comprised of all participants who were randomly assigned to trial intervention, received the trial intervention, and have at least one valid ADA result
The formation of ADAs (immunogenicity) following MAM01 SC and/or IV administration) was evaluated by measuring titers of ADA to MAM01 to last study visit for all participants. Capillary blood samples and selected serum samples were collected on volumetric absorptive micro-sampling (VAMS) devices at timepoints.
Outcome measures
| Measure |
Part A (SAD Cohort 3): Repeat Dose MAM01 5 mg/kg SC
n=6 Participants
Participants received a second dose of MAM01 5 mg/kg SC following CHMI, regardless of the initial randomized treatment allocation.
|
Part A (SAD Cohort 1): MAM01 1.5 mg/kg IV
n=6 Participants
Participants were randomized to receive a single IV dose of MAM01 1.5 mg/kg.
|
Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 900 mg/kg.
|
Part A (SAD Cohort 3): MAM01 5 mg/kg IV
n=6 Participants
Participants were randomized to receive single IV dose of MAM01 5 mg/kg.
|
Part A (SAD Cohort 4): MAM01 10 mg/kg IV
Participants were randomized to receive a single IV dose of MAM01 10 mg/kg.
|
Part A (SAD Cohort 5): MAM01 40 mg/kg IV
Participants were randomized to receive a single IV dose of MAM01 40 mg/kg.
|
Part B (Cohort 6, Group 1): MAM01 450 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 450 mg/kg.
|
Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 600 mg/kg.
|
Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 600 mg/kg.
|
Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 900 mg/kg.
|
Part B: Infectivity Controls
Non-randomized participants were enrolled prior to CHMI, did not receive treatment and acted as infectivity controls.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cohorts 1, 4 and 5: Numbers of Participants With Seroconversion
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 378Population: Immunogenicity Population.
The formation of ADAs (immunogenicity) following MAM01 SC and/or IV administration) was evaluated by measuring titers of ADA to MAM01 to last study visit for all participants. Capillary blood samples and selected serum samples were collected on volumetric absorptive micro-sampling (VAMS) devices at timepoints.
Outcome measures
| Measure |
Part A (SAD Cohort 3): Repeat Dose MAM01 5 mg/kg SC
n=6 Participants
Participants received a second dose of MAM01 5 mg/kg SC following CHMI, regardless of the initial randomized treatment allocation.
|
Part A (SAD Cohort 1): MAM01 1.5 mg/kg IV
n=6 Participants
Participants were randomized to receive a single IV dose of MAM01 1.5 mg/kg.
|
Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 900 mg/kg.
|
Part A (SAD Cohort 3): MAM01 5 mg/kg IV
Participants were randomized to receive single IV dose of MAM01 5 mg/kg.
|
Part A (SAD Cohort 4): MAM01 10 mg/kg IV
Participants were randomized to receive a single IV dose of MAM01 10 mg/kg.
|
Part A (SAD Cohort 5): MAM01 40 mg/kg IV
Participants were randomized to receive a single IV dose of MAM01 40 mg/kg.
|
Part B (Cohort 6, Group 1): MAM01 450 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 450 mg/kg.
|
Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 600 mg/kg.
|
Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 600 mg/kg.
|
Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 900 mg/kg.
|
Part B: Infectivity Controls
Non-randomized participants were enrolled prior to CHMI, did not receive treatment and acted as infectivity controls.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cohorts 2 and 3: Numbers of Participants Receiving 2 Doses With Seroconversion
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 84Population: Immunogenicity Population.
The formation of ADAs (immunogenicity) following MAM01 SC and/or IV administration) was evaluated by measuring titers of ADA to MAM01 to last study visit for all participants. Capillary blood samples and selected serum samples were collected on volumetric absorptive micro-sampling (VAMS) devices at timepoints.
Outcome measures
| Measure |
Part A (SAD Cohort 3): Repeat Dose MAM01 5 mg/kg SC
n=6 Participants
Participants received a second dose of MAM01 5 mg/kg SC following CHMI, regardless of the initial randomized treatment allocation.
|
Part A (SAD Cohort 1): MAM01 1.5 mg/kg IV
n=6 Participants
Participants were randomized to receive a single IV dose of MAM01 1.5 mg/kg.
|
Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 900 mg/kg.
|
Part A (SAD Cohort 3): MAM01 5 mg/kg IV
n=6 Participants
Participants were randomized to receive single IV dose of MAM01 5 mg/kg.
|
Part A (SAD Cohort 4): MAM01 10 mg/kg IV
Participants were randomized to receive a single IV dose of MAM01 10 mg/kg.
|
Part A (SAD Cohort 5): MAM01 40 mg/kg IV
Participants were randomized to receive a single IV dose of MAM01 40 mg/kg.
|
Part B (Cohort 6, Group 1): MAM01 450 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 450 mg/kg.
|
Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 600 mg/kg.
|
Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 600 mg/kg.
|
Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC
Participants were randomized to receive single SC dose of MAM01 900 mg/kg.
|
Part B: Infectivity Controls
Non-randomized participants were enrolled prior to CHMI, did not receive treatment and acted as infectivity controls.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cohort 6: Numbers of Participants With Seroconversion
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Part A (SAD Cohort 1): MAM01 1.5 mg/kg IV
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A (SAD Cohort 2): MAM01 5 mg/kg SC (Repeat Dose 5 mg/kg SC)
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Part A (SAD Cohort 3): MAM01 5 mg/kg IV (Repeat Dose 5 mg/kg SC)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part A (SAD Cohort 4): MAM01 10 mg/kg IV
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part A (SAD Cohort 5): MAM01 40 mg/kg IV
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part A: Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part A: Infectivity Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part B (Cohort 6, Group 1): MAM01 450 mg/kg SC
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part B: Infectivity Controls
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A (SAD Cohort 1): MAM01 1.5 mg/kg IV
n=6 participants at risk
Participants were randomized to receive a single IV dose of MAM01 1.5 mg/kg.
|
Part A (SAD Cohort 2): MAM01 5 mg/kg SC (Repeat Dose 5 mg/kg SC)
n=6 participants at risk
Participants were randomized to receive single SC dose of MAM01 5 mg/kg. Participants received a second dose of 5 mg/kg SC of MAM01 following CHMI, 30 weeks after receiving the first dose, regardless of the initial randomized treatment allocation.
|
Part A (SAD Cohort 3): MAM01 5 mg/kg IV (Repeat Dose 5 mg/kg SC)
n=6 participants at risk
Participants were randomized to receive Single IV dose of MAM01 5 mg/kg. Participants received a second dose of 5 mg/kg SC of MAM01 following CHMI, 30 weeks after receiving the first dose, regardless of the initial randomized treatment allocation.
|
Part A (SAD Cohort 4): MAM01 10 mg/kg IV
n=6 participants at risk
Participants were randomized to receive a single IV dose of MAM01 10 mg/kg.
|
Part A (SAD Cohort 5): MAM01 40 mg/kg IV
n=6 participants at risk
Participants were randomized to receive a single IV dose of MAM01 40 mg/kg.
|
Part A: Placebo
n=7 participants at risk
Participants were randomized to receive a single IV dose of placebo (formulation buffer without MAM01 active ingredient). They also served as infectivity controls for the CHMI.
|
Part A: Infectivity Controls
n=1 participants at risk
Non-randomized participants were enrolled prior to CHMI, did not receive treatment and acted as additional infectivity controls.
|
Part B (Cohort 6, Group 1): MAM01 450 mg/kg SC
n=6 participants at risk
Participants were randomized to receive single SC dose of MAM01 450 mg/kg.
|
Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC
n=6 participants at risk
Participants were randomized to receive single SC dose of MAM01 600 mg/kg.
|
Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC
n=6 participants at risk
Participants were randomized to receive single SC dose of MAM01 900 mg/kg.
|
Part B: Infectivity Controls
n=6 participants at risk
Non-randomized participants were enrolled prior to CHMI, did not receive treatment and acted as infectivity controls.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Psychiatric disorders
Depression suicidal
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/7 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/1 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
Other adverse events
| Measure |
Part A (SAD Cohort 1): MAM01 1.5 mg/kg IV
n=6 participants at risk
Participants were randomized to receive a single IV dose of MAM01 1.5 mg/kg.
|
Part A (SAD Cohort 2): MAM01 5 mg/kg SC (Repeat Dose 5 mg/kg SC)
n=6 participants at risk
Participants were randomized to receive single SC dose of MAM01 5 mg/kg. Participants received a second dose of 5 mg/kg SC of MAM01 following CHMI, 30 weeks after receiving the first dose, regardless of the initial randomized treatment allocation.
|
Part A (SAD Cohort 3): MAM01 5 mg/kg IV (Repeat Dose 5 mg/kg SC)
n=6 participants at risk
Participants were randomized to receive Single IV dose of MAM01 5 mg/kg. Participants received a second dose of 5 mg/kg SC of MAM01 following CHMI, 30 weeks after receiving the first dose, regardless of the initial randomized treatment allocation.
|
Part A (SAD Cohort 4): MAM01 10 mg/kg IV
n=6 participants at risk
Participants were randomized to receive a single IV dose of MAM01 10 mg/kg.
|
Part A (SAD Cohort 5): MAM01 40 mg/kg IV
n=6 participants at risk
Participants were randomized to receive a single IV dose of MAM01 40 mg/kg.
|
Part A: Placebo
n=7 participants at risk
Participants were randomized to receive a single IV dose of placebo (formulation buffer without MAM01 active ingredient). They also served as infectivity controls for the CHMI.
|
Part A: Infectivity Controls
n=1 participants at risk
Non-randomized participants were enrolled prior to CHMI, did not receive treatment and acted as additional infectivity controls.
|
Part B (Cohort 6, Group 1): MAM01 450 mg/kg SC
n=6 participants at risk
Participants were randomized to receive single SC dose of MAM01 450 mg/kg.
|
Part B (Cohort 6, Group 2): MAM01 600 mg/kg SC
n=6 participants at risk
Participants were randomized to receive single SC dose of MAM01 600 mg/kg.
|
Part B (Cohort 6, Group 3): MAM01 900 mg/kg SC
n=6 participants at risk
Participants were randomized to receive single SC dose of MAM01 900 mg/kg.
|
Part B: Infectivity Controls
n=6 participants at risk
Non-randomized participants were enrolled prior to CHMI, did not receive treatment and acted as infectivity controls.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/7 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/1 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
|
Ear and labyrinth disorders
Ear pain
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/7 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/1 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/7 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/1 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/7 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/1 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
|
General disorders
Injection site pain
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/7 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/1 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
33.3%
2/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
|
General disorders
Injection site redness
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/7 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/1 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
33.3%
2/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
|
General disorders
Injection site swelling
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/7 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/1 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
|
General disorders
Injection site itching
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/7 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/1 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
|
General disorders
Injection site bruising
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/7 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/1 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
|
Infections and infestations
Respiratory tract infection viral
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
33.3%
2/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/7 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/1 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
|
Infections and infestations
COVID-19
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/7 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/1 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/7 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/1 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
|
Infections and infestations
Otitis externa
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/7 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/1 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/7 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/1 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
33.3%
2/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
|
Infections and infestations
Viral infection
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/7 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/1 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
|
Infections and infestations
Viral pharyngitis
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/7 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/1 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/7 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/1 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
14.3%
1/7 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/1 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
14.3%
1/7 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/1 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
14.3%
1/7 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/1 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/7 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/1 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/7 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/1 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
|
Injury, poisoning and procedural complications
Mouth injury
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/7 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/1 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
|
Investigations
Blood pressure increased
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/7 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/1 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
|
Investigations
Blood pressure systolic increased
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/7 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/1 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
|
Investigations
Heart rate increased
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/7 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/1 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/7 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/1 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/7 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/1 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/7 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/1 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
14.3%
1/7 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/1 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/7 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/1 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/7 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/1 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/7 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/1 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
14.3%
1/7 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/1 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/7 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/1 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/7 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/1 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
33.3%
2/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
33.3%
2/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
28.6%
2/7 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/1 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/7 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/1 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/7 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/1 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
|
General disorders
Chills
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/7 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/1 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
|
General disorders
Fatigue
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
28.6%
2/7 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/1 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/7 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/1 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
|
Musculoskeletal and connective tissue disorders
Muscle pain
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
14.3%
1/7 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/1 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
33.3%
2/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
14.3%
1/7 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/1 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
|
General disorders
Injection site haematoma
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
16.7%
1/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/7 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/1 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
|
General disorders
Puncture site bruise
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
14.3%
1/7 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/1 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
0.00%
0/6 • Solicited AEs collected daily from Day 1 to Day 7 post dose (included injection site pain, redness, swelling, itching, bruising, fever, chills, headache, fatigue, nausea, muscle pain and joint pain) Unsolicited AEs were collected for 28 days after each dose. SAEs were collected from Screening through End of Study (Day 378 for Part A and Day 84 for Part B).
Serious and non-serious adverse events were collected for the Safety Population. The number of participants with data for all Solicited and Unsolicited adverse events was recorded.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER