Trial Outcomes & Findings for A Study in Healthy Volunteers and in Participants With Chronic Hepatitis B to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of RO7020531 (NCT NCT02956850)
NCT ID: NCT02956850
Last Updated: 2024-02-08
Results Overview
An AE is any untoward medical occurrence in a clinical investigation healthy volunteer (HV)/participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product, any new disease or exacerbation of an existing disease (a worsening in the character, frequency, or severity of a known condition and recurrence of an intermittent medical condition (e.g., headache) not present at baseline.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
160 participants
Primary outcome timeframe
From randomization up to Day 29
Results posted on
2024-02-08
Participant Flow
Participants were enrolled at 16 investigative sites in New Zealand, Hong Kong, Thailand, Taiwan, New Zealand, Bulgaria, United Kingdom, Italy and Netherlands from 12 December 2016 to 15 June 2021.
A total of 160 participants were enrolled in the study. 110 participants were enrolled in Part 1 and 50 participants were enrolled in Part 2.
Participant milestones
| Measure |
Part 1 Cohorts 1-8, Single Ascending Dose (SAD): Placebo
In SAD Cohorts 1-8, sixteen healthy volunteers (HVs), two in each cohort, received a single dose of RO7020531 matching placebo, on Day 1
|
Part 1 SAD: Cohort 1
HVs received single dose of RO7020531, 3 milligrams (mg), orally on Day 1.
|
Part 1 SAD: Cohort 2
HVs received single dose of RO7020531, 10 mg, orally on Day 1.
|
Part 1 SAD: Cohort 3
HVs received single dose of RO7020531, 20 mg, orally on Day 1.
|
Part 1 SAD: Cohort 4
HVs received single dose of RO7020531, 40 mg, orally on Day 1.
|
Part 1 SAD: Cohort 5
HVs received single dose of RO7020531, 60 mg, orally on Day 1.
|
Part 1 SAD: Cohort 6
HVs received single dose of RO7020531, 100 mg, orally on Day 1.
|
Part 1 SAD: Cohort 7
HVs received single dose of RO7020531, 140 mg, orally on Day 1.
|
Part 1 SAD: Cohort 8
HVs received single dose of RO7020531, 170 mg, orally on Day 1.
|
Part 1 Cohorts 1-3, Multiple Ascending Dose (MAD): Placebo
In MAD Cohorts 1,2, and 3, six HVs, two in each cohort, received RO7020531 matching placebo orally on Day 1 and every other day (QOD) for 13 days.
|
Part 1 MAD: Cohort 1
HVs received RO7020531, 100 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 2
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
Part 2 Cohorts 1-3: Placebo
In Cohorts 1,2, and 3, six participants, two in each cohort, Participants received RO7020531 matching placebo, along with nucleoside/nucleotide analogue (NUC) treatment, orally, on Day 1 and QOD for 41 days.
|
Part 2: Cohort 1 and 2
Sixteen participants received RO7020531, 150 mg, along with NUC treatment, orally, on Day 1 and QOD for 41 days. Cohorts 1 and 2 were both 150 mg cohorts and was presented as a single dose group.
|
Part 2: Cohort 3
Participants received RO7020531, 170 mg, along with NUC treatment, orally, on Day 1 and QOD for 41 days.
|
Part 2 Cohort 4: Placebo
Treatment naive participants received RO7020531 matching placebo, orally, on Day 1 and QOD for 41 days.
|
Part 2: Cohort 4
Treatment naive participants received RO7020531, 150 mg, orally, on Day 1 and QOD for 41 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
8
|
8
|
8
|
8
|
8
|
8
|
8
|
8
|
6
|
8
|
8
|
8
|
6
|
16
|
8
|
5
|
15
|
|
Overall Study
COMPLETED
|
16
|
8
|
8
|
8
|
8
|
8
|
8
|
8
|
8
|
6
|
8
|
8
|
8
|
6
|
16
|
8
|
5
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Part 1 Cohorts 1-8, Single Ascending Dose (SAD): Placebo
In SAD Cohorts 1-8, sixteen healthy volunteers (HVs), two in each cohort, received a single dose of RO7020531 matching placebo, on Day 1
|
Part 1 SAD: Cohort 1
HVs received single dose of RO7020531, 3 milligrams (mg), orally on Day 1.
|
Part 1 SAD: Cohort 2
HVs received single dose of RO7020531, 10 mg, orally on Day 1.
|
Part 1 SAD: Cohort 3
HVs received single dose of RO7020531, 20 mg, orally on Day 1.
|
Part 1 SAD: Cohort 4
HVs received single dose of RO7020531, 40 mg, orally on Day 1.
|
Part 1 SAD: Cohort 5
HVs received single dose of RO7020531, 60 mg, orally on Day 1.
|
Part 1 SAD: Cohort 6
HVs received single dose of RO7020531, 100 mg, orally on Day 1.
|
Part 1 SAD: Cohort 7
HVs received single dose of RO7020531, 140 mg, orally on Day 1.
|
Part 1 SAD: Cohort 8
HVs received single dose of RO7020531, 170 mg, orally on Day 1.
|
Part 1 Cohorts 1-3, Multiple Ascending Dose (MAD): Placebo
In MAD Cohorts 1,2, and 3, six HVs, two in each cohort, received RO7020531 matching placebo orally on Day 1 and every other day (QOD) for 13 days.
|
Part 1 MAD: Cohort 1
HVs received RO7020531, 100 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 2
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
Part 2 Cohorts 1-3: Placebo
In Cohorts 1,2, and 3, six participants, two in each cohort, Participants received RO7020531 matching placebo, along with nucleoside/nucleotide analogue (NUC) treatment, orally, on Day 1 and QOD for 41 days.
|
Part 2: Cohort 1 and 2
Sixteen participants received RO7020531, 150 mg, along with NUC treatment, orally, on Day 1 and QOD for 41 days. Cohorts 1 and 2 were both 150 mg cohorts and was presented as a single dose group.
|
Part 2: Cohort 3
Participants received RO7020531, 170 mg, along with NUC treatment, orally, on Day 1 and QOD for 41 days.
|
Part 2 Cohort 4: Placebo
Treatment naive participants received RO7020531 matching placebo, orally, on Day 1 and QOD for 41 days.
|
Part 2: Cohort 4
Treatment naive participants received RO7020531, 150 mg, orally, on Day 1 and QOD for 41 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study in Healthy Volunteers and in Participants With Chronic Hepatitis B to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of RO7020531
Baseline characteristics by cohort
| Measure |
Part 1 Cohorts 1-8 SAD: Placebo
n=16 Participants
In SAD Cohorts 1-8, sixteen HVs, two in each cohort, received a single dose of RO7020531 matching placebo, on Day 1.
|
Part 1 SAD: Cohort 1
n=8 Participants
HVs received single dose of RO7020531, 3 mg, orally on Day 1.
|
Part 1 SAD: Cohort 2
n=8 Participants
HVs received single dose of RO7020531, 10 mg, orally on Day 1.
|
Part 1 SAD: Cohort 3
n=8 Participants
HVs received single dose of RO7020531, 20 mg, orally on Day 1.
|
Part 1 SAD: Cohort 4
n=8 Participants
HVs received single dose of RO7020531, 40 mg, orally on Day 1.
|
Part 1 SAD: Cohort 5
n=8 Participants
HVs received single dose of RO7020531, 60 mg, orally on Day 1.
|
Part 1 SAD: Cohort 6
n=8 Participants
HVs received single dose of RO7020531, 100 mg, orally on Day 1.
|
Part 1 SAD: Cohort 7
n=8 Participants
HVs received single dose of RO7020531, 140 mg, orally on Day 1.
|
Part 1 SAD: Cohort 8
n=8 Participants
HVs received single dose of RO7020531, 170 mg, orally on Day 1.
|
Part 1 Cohorts 1-3, MAD: Placebo
n=6 Participants
In MAD Cohorts 1,2, and 3, six HVs, two in each cohort, received RO7020531 matching placebo orally on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 1
n=8 Participants
HVs received RO7020531, 100 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 2
n=8 Participants
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
n=8 Participants
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
Part 2 Cohorts 1-3: Placebo
n=6 Participants
In Cohorts 1,2, and 3, six participants, two in each cohort, Participants received RO7020531 matching placebo, along with NUC treatment, orally, on Day 1 and QOD for 41 days.
|
Part 2: Cohort 1 and 2
n=16 Participants
Sixteen participants received RO7020531, 150 mg, along with NUC treatment, orally, on Day 1 and QOD for 41 days. Cohorts 1 and 2 were both 150 mg cohorts and was presented as a single dose group.
|
Part 2: Cohort 3
n=8 Participants
Participants received RO7020531, 170 mg, along with NUC treatment, orally, on Day 1 and QOD for 41 days.
|
Part 2 Cohort 4: Placebo
n=5 Participants
Treatment naive participants received RO7020531 matching placebo, orally, on Day 1 and QOD for 41 days.
|
Part 2: Cohort 4
n=15 Participants
Treatment naive participants received RO7020531, 150 mg, orally, on Day 1 and QOD for 41 days.
|
Total
n=160 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
28.7 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
31.5 years
STANDARD_DEVIATION 15.8 • n=7 Participants
|
37.6 years
STANDARD_DEVIATION 16.2 • n=5 Participants
|
22.6 years
STANDARD_DEVIATION 2.7 • n=4 Participants
|
23.8 years
STANDARD_DEVIATION 4.5 • n=21 Participants
|
29.3 years
STANDARD_DEVIATION 7.0 • n=8 Participants
|
33.4 years
STANDARD_DEVIATION 12.5 • n=8 Participants
|
25.8 years
STANDARD_DEVIATION 3.5 • n=24 Participants
|
29.5 years
STANDARD_DEVIATION 10.9 • n=42 Participants
|
27.2 years
STANDARD_DEVIATION 4.0 • n=42 Participants
|
26.8 years
STANDARD_DEVIATION 3.9 • n=42 Participants
|
26.5 years
STANDARD_DEVIATION 2.9 • n=42 Participants
|
25.0 years
STANDARD_DEVIATION 7.5 • n=36 Participants
|
49.3 years
STANDARD_DEVIATION 13.3 • n=36 Participants
|
47.6 years
STANDARD_DEVIATION 8.9 • n=24 Participants
|
42.4 years
STANDARD_DEVIATION 10.5 • n=135 Participants
|
42.6 years
STANDARD_DEVIATION 11.5 • n=136 Participants
|
40.1 years
STANDARD_DEVIATION 9.3 • n=44 Participants
|
33.3 years
STANDARD_DEVIATION 12.2 • n=667 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
4 Participants
n=24 Participants
|
2 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
9 Participants
n=44 Participants
|
48 Participants
n=667 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
6 Participants
n=36 Participants
|
5 Participants
n=36 Participants
|
12 Participants
n=24 Participants
|
6 Participants
n=135 Participants
|
4 Participants
n=136 Participants
|
6 Participants
n=44 Participants
|
112 Participants
n=667 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
6 Participants
n=667 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
8 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
8 Participants
n=36 Participants
|
6 Participants
n=36 Participants
|
15 Participants
n=24 Participants
|
8 Participants
n=135 Participants
|
5 Participants
n=136 Participants
|
14 Participants
n=44 Participants
|
152 Participants
n=667 Participants
|
|
Race/Ethnicity, Customized
Not Stated
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
1 Participants
n=667 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
1 Participants
n=667 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
9 Participants
n=24 Participants
|
5 Participants
n=135 Participants
|
2 Participants
n=136 Participants
|
6 Participants
n=44 Participants
|
44 Participants
n=667 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
3 Participants
n=667 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
7 Participants
n=667 Participants
|
|
Race/Ethnicity, Customized
White
|
13 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
4 Participants
n=36 Participants
|
4 Participants
n=36 Participants
|
5 Participants
n=24 Participants
|
3 Participants
n=135 Participants
|
3 Participants
n=136 Participants
|
8 Participants
n=44 Participants
|
103 Participants
n=667 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
3 Participants
n=667 Participants
|
PRIMARY outcome
Timeframe: From randomization up to Day 29Population: Safety analysis population included all HVs who had received at least 1 dose of study drug.
An AE is any untoward medical occurrence in a clinical investigation healthy volunteer (HV)/participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product, any new disease or exacerbation of an existing disease (a worsening in the character, frequency, or severity of a known condition and recurrence of an intermittent medical condition (e.g., headache) not present at baseline.
Outcome measures
| Measure |
Part 1 Cohorts 1-8 SAD: Placebo
n=16 Participants
In SAD Cohorts 1-8, sixteen HVs, two in each cohort, received a single dose of RO7020531 matching placebo, on Day 1.
|
Part 1 SAD: Cohort 1
n=8 Participants
HVs received single dose of RO7020531, 3 mg, orally on Day 1.
|
Part 1 SAD: Cohort 2
n=8 Participants
HVs received single dose of RO7020531, 10 mg, orally on Day 1.
|
Part 1 SAD: Cohort 3
n=8 Participants
HVs received single dose of RO7020531, 20 mg, orally on Day 1.
|
Part 1 SAD: Cohort 4
n=8 Participants
HVs received single dose of RO7020531, 40 mg, orally on Day 1.
|
Part 1 SAD: Cohort 5
n=8 Participants
HVs received single dose of RO7020531, 60 mg, orally on Day 1.
|
Part 1 SAD: Cohort 6
n=8 Participants
HVs received single dose of RO7020531, 100 mg, orally on Day 1.
|
Part 1 SAD: Cohort 7
n=8 Participants
HVs received single dose of RO7020531, 140 mg, orally on Day 1.
|
Part 1 SAD: Cohort 8
n=8 Participants
HVs received single dose of RO7020531, 170 mg, orally on Day 1.
|
Part 1 MAD: Cohort 2
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 2
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Percentage of SAD Participants With Adverse Events (AEs)
|
31.3 percentage of participants
|
25.0 percentage of participants
|
50.0 percentage of participants
|
25.0 percentage of participants
|
25.0 percentage of participants
|
25.0 percentage of participants
|
25.0 percentage of participants
|
25.0 percentage of participants
|
37.5 percentage of participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From randomization up to Day 41Population: Safety analysis population included all HVs who had received at least 1 dose of study drug.
An AE is any untoward medical occurrence in a clinical investigation healthy volunteer (HV)/participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product, any new disease or exacerbation of an existing disease (a worsening in the character, frequency, or severity of a known condition and recurrence of an intermittent medical condition (e.g., headache) not present at baseline.
Outcome measures
| Measure |
Part 1 Cohorts 1-8 SAD: Placebo
n=6 Participants
In SAD Cohorts 1-8, sixteen HVs, two in each cohort, received a single dose of RO7020531 matching placebo, on Day 1.
|
Part 1 SAD: Cohort 1
n=8 Participants
HVs received single dose of RO7020531, 3 mg, orally on Day 1.
|
Part 1 SAD: Cohort 2
n=8 Participants
HVs received single dose of RO7020531, 10 mg, orally on Day 1.
|
Part 1 SAD: Cohort 3
n=8 Participants
HVs received single dose of RO7020531, 20 mg, orally on Day 1.
|
Part 1 SAD: Cohort 4
HVs received single dose of RO7020531, 40 mg, orally on Day 1.
|
Part 1 SAD: Cohort 5
HVs received single dose of RO7020531, 60 mg, orally on Day 1.
|
Part 1 SAD: Cohort 6
HVs received single dose of RO7020531, 100 mg, orally on Day 1.
|
Part 1 SAD: Cohort 7
HVs received single dose of RO7020531, 140 mg, orally on Day 1.
|
Part 1 SAD: Cohort 8
HVs received single dose of RO7020531, 170 mg, orally on Day 1.
|
Part 1 MAD: Cohort 2
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 2
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Percentage of MAD Participants With AEs
|
83.3 percentage of participants
|
75.0 percentage of participants
|
87.5 percentage of participants
|
87.5 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From randomization up to Week 12Population: Safety analysis population included all participants who had received at least 1 dose of study drug.
An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product, any new disease or exacerbation of an existing disease (a worsening in the character, frequency, or severity of a known condition and recurrence of an intermittent medical condition (e.g., headache) not present at baseline.
Outcome measures
| Measure |
Part 1 Cohorts 1-8 SAD: Placebo
n=6 Participants
In SAD Cohorts 1-8, sixteen HVs, two in each cohort, received a single dose of RO7020531 matching placebo, on Day 1.
|
Part 1 SAD: Cohort 1
n=16 Participants
HVs received single dose of RO7020531, 3 mg, orally on Day 1.
|
Part 1 SAD: Cohort 2
n=8 Participants
HVs received single dose of RO7020531, 10 mg, orally on Day 1.
|
Part 1 SAD: Cohort 3
n=5 Participants
HVs received single dose of RO7020531, 20 mg, orally on Day 1.
|
Part 1 SAD: Cohort 4
n=15 Participants
HVs received single dose of RO7020531, 40 mg, orally on Day 1.
|
Part 1 SAD: Cohort 5
HVs received single dose of RO7020531, 60 mg, orally on Day 1.
|
Part 1 SAD: Cohort 6
HVs received single dose of RO7020531, 100 mg, orally on Day 1.
|
Part 1 SAD: Cohort 7
HVs received single dose of RO7020531, 140 mg, orally on Day 1.
|
Part 1 SAD: Cohort 8
HVs received single dose of RO7020531, 170 mg, orally on Day 1.
|
Part 1 MAD: Cohort 2
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 2
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Percentage of Chronic Hepatitis B Participants With AEs
|
50.0 percentage of participants
|
68.8 percentage of participants
|
75.0 percentage of participants
|
60.0 percentage of participants
|
80.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From randomization up to Day 8Population: Safety population included all HVs who had received at least 1 dose of study drug. Number analyzed is the number of participants with data available for analysis at the specified time point.
For all laboratory parameters included, there exists a Roche predefined standard reference range. Laboratory values falling outside this standard reference range were labeled "H" for high or "L" for low in HV/participant listings of laboratory data.
Outcome measures
| Measure |
Part 1 Cohorts 1-8 SAD: Placebo
n=16 Participants
In SAD Cohorts 1-8, sixteen HVs, two in each cohort, received a single dose of RO7020531 matching placebo, on Day 1.
|
Part 1 SAD: Cohort 1
n=8 Participants
HVs received single dose of RO7020531, 3 mg, orally on Day 1.
|
Part 1 SAD: Cohort 2
n=8 Participants
HVs received single dose of RO7020531, 10 mg, orally on Day 1.
|
Part 1 SAD: Cohort 3
n=8 Participants
HVs received single dose of RO7020531, 20 mg, orally on Day 1.
|
Part 1 SAD: Cohort 4
n=8 Participants
HVs received single dose of RO7020531, 40 mg, orally on Day 1.
|
Part 1 SAD: Cohort 5
n=8 Participants
HVs received single dose of RO7020531, 60 mg, orally on Day 1.
|
Part 1 SAD: Cohort 6
n=8 Participants
HVs received single dose of RO7020531, 100 mg, orally on Day 1.
|
Part 1 SAD: Cohort 7
n=8 Participants
HVs received single dose of RO7020531, 140 mg, orally on Day 1.
|
Part 1 SAD: Cohort 8
n=8 Participants
HVs received single dose of RO7020531, 170 mg, orally on Day 1.
|
Part 1 MAD: Cohort 2
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 2
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Monocytes Absolute - High
|
0 percentage of participants
|
12.5 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Protein, Total - High
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Creatinine - Low
|
0 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Creatinine - High
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Cystatin C - Low
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Eosinophils Absolute - High
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Erythrocyte Mean Corpuscular HGB Concentration - Low
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Erythrocyte Mean Corpuscular Hemoglobin - Low
|
6.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Erythrocyte Mean Corpuscular Volume - High
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Hematocrit - Low
|
6.7 percentage of participants
|
25.0 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
25.0 percentage of participants
|
12.5 percentage of participants
|
12.5 percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Hemoglobin - Low
|
6.3 percentage of participants
|
25.0 percentage of participants
|
12.5 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
25.0 percentage of participants
|
0 percentage of participants
|
25.0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Hemoglobin - High
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Lymphocytes Absolute - Low
|
0 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Neutrophils, Total, Absolute - Low
|
7.1 percentage of participants
|
14.3 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Neutrophils, Total, Absolute - High
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Platelet - Low
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Platelet - High
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Red Blood Cell Count - Low
|
6.3 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Red Blood Cell Count - High
|
6.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Reticulocytes, Pct - High
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
White Blood Cell Count - Low
|
13.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
White Blood Cell Count - High
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Albumin - Low
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
14.3 percentage of participants
|
12.5 percentage of participants
|
12.5 percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Alkaline Phosphatase - Low
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Alkaline Phosphatase - High
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Bicarbonate CO2 - Low
|
6.3 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Blood Glucose, Fasting - High
|
7.1 percentage of participants
|
12.5 percentage of participants
|
50.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
42.9 percentage of participants
|
12.5 percentage of participants
|
14.3 percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Blood Urea Nitrogen - Low
|
7.1 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
14.3 percentage of participants
|
14.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
40.0 percentage of participants
|
40.0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Blood Urea Nitrogen - High
|
6.3 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Calcium - High
|
6.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Chloride - Low
|
6.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Cholesterol - High
|
8.3 percentage of participants
|
20.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
25.0 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
14.3 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Cystatin C - High
|
13.3 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
25.0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Direct Bilirubin - High
|
14.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Phosphorus - High
|
6.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Potassium - Low
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Protein, Total - Low
|
20.0 percentage of participants
|
14.3 percentage of participants
|
25.0 percentage of participants
|
25.0 percentage of participants
|
12.5 percentage of participants
|
25.0 percentage of participants
|
16.7 percentage of participants
|
28.6 percentage of participants
|
12.5 percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
SGOT/AST - High
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
SGPT/ALT - High
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
14.3 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Sodium - High
|
6.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Triglycerides, Fasting - High
|
0 percentage of participants
|
0 percentage of participants
|
14.3 percentage of participants
|
0 percentage of participants
|
28.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Uric Acid - High
|
7.1 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
14.3 percentage of participants
|
25.0 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Creatinine Clearance - Low
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
35.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of SAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Creatinine Clearance - High
|
23.1 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
20.0 percentage of participants
|
20.0 percentage of participants
|
25.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From randomization up to Day 20Population: Safety analysis population included all HVs who had received at least 1 dose of study drug. Number analyzed is the number of participants with data available for analysis at the specified time point.
For all laboratory parameters included, there exists a Roche predefined standard reference range. Laboratory values falling outside this standard reference range were labeled "H" for high or "L" for low in HV/participant listings of laboratory data.
Outcome measures
| Measure |
Part 1 Cohorts 1-8 SAD: Placebo
n=6 Participants
In SAD Cohorts 1-8, sixteen HVs, two in each cohort, received a single dose of RO7020531 matching placebo, on Day 1.
|
Part 1 SAD: Cohort 1
n=8 Participants
HVs received single dose of RO7020531, 3 mg, orally on Day 1.
|
Part 1 SAD: Cohort 2
n=8 Participants
HVs received single dose of RO7020531, 10 mg, orally on Day 1.
|
Part 1 SAD: Cohort 3
n=8 Participants
HVs received single dose of RO7020531, 20 mg, orally on Day 1.
|
Part 1 SAD: Cohort 4
HVs received single dose of RO7020531, 40 mg, orally on Day 1.
|
Part 1 SAD: Cohort 5
HVs received single dose of RO7020531, 60 mg, orally on Day 1.
|
Part 1 SAD: Cohort 6
HVs received single dose of RO7020531, 100 mg, orally on Day 1.
|
Part 1 SAD: Cohort 7
HVs received single dose of RO7020531, 140 mg, orally on Day 1.
|
Part 1 SAD: Cohort 8
HVs received single dose of RO7020531, 170 mg, orally on Day 1.
|
Part 1 MAD: Cohort 2
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 2
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Eosinophils Absolute - High
|
0 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Erythrocyte Mean Corpuscular HGB Concentration - Low
|
0 percentage of participants
|
0 percentage of participants
|
28.6 percentage of participants
|
42.9 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Erythrocyte Mean Corpuscular HGB Concentration - High
|
0 percentage of participants
|
14.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Erythrocyte Mean Corpuscular Hemoglobin - Low
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Hematocrit - Low
|
16.7 percentage of participants
|
62.5 percentage of participants
|
62.5 percentage of participants
|
37.5 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Hemoglobin - Low
|
16.7 percentage of participants
|
50.0 percentage of participants
|
62.5 percentage of participants
|
37.5 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Neutrophils, Total, Absolute
|
16.7 percentage of participants
|
25.0 percentage of participants
|
16.7 percentage of participants
|
37.5 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Red blood cell count - Low
|
0 percentage of participants
|
0 percentage of participants
|
25.0 percentage of participants
|
25.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Reticulocytes, Pct - High
|
0 percentage of participants
|
0 percentage of participants
|
25.0 percentage of participants
|
12.5 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
White Blood Cell Count - Low
|
0 percentage of participants
|
0 percentage of participants
|
20.0 percentage of participants
|
25.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Albumin - Low
|
40.0 percentage of participants
|
37.5 percentage of participants
|
37.5 percentage of participants
|
25.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Alkaline Phosphatase - Low
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Bicarbonate CO2 - Low
|
16.7 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Blood Glucose, Fasting - High
|
20.0 percentage of participants
|
12.5 percentage of participants
|
16.7 percentage of participants
|
14.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Blood Urea Nitrogen - Low
|
33.3 percentage of participants
|
33.3 percentage of participants
|
80.0 percentage of participants
|
100.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Cholesterol - High
|
16.7 percentage of participants
|
12.5 percentage of participants
|
20.0 percentage of participants
|
14.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Creatinine - Low
|
0 percentage of participants
|
25.0 percentage of participants
|
0 percentage of participants
|
42.9 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Cystatin C - High
|
0 percentage of participants
|
33.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Direct Bilirubin - High
|
20.0 percentage of participants
|
14.3 percentage of participants
|
0 percentage of participants
|
14.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Phosphorus - High
|
0 percentage of participants
|
12.5 percentage of participants
|
12.5 percentage of participants
|
25.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Protein, Total - Low
|
25.0 percentage of participants
|
75.0 percentage of participants
|
50.0 percentage of participants
|
62.5 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
SGOT/AST - High
|
0 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
SGPT/ALT - High
|
0 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
14.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Uric Acid - Low
|
0 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Uric Acid - High
|
16.7 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Creatinine Clearance - Low
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of MAD Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Creatinine Clearance - High
|
66.7 percentage of participants
|
33.3 percentage of participants
|
20.0 percentage of participants
|
33.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From randomization up to Week 12Population: Safety analysis population included all HVs who had received at least 1 dose of study drug. Number analyzed is the number of participants with data available for analysis at the specified time point.
For all laboratory parameters included, there exists a Roche predefined standard reference range. Laboratory values falling outside this standard reference range were labeled "H" for high or "L" for low in HV/participant listings of laboratory data.
Outcome measures
| Measure |
Part 1 Cohorts 1-8 SAD: Placebo
n=6 Participants
In SAD Cohorts 1-8, sixteen HVs, two in each cohort, received a single dose of RO7020531 matching placebo, on Day 1.
|
Part 1 SAD: Cohort 1
n=16 Participants
HVs received single dose of RO7020531, 3 mg, orally on Day 1.
|
Part 1 SAD: Cohort 2
n=8 Participants
HVs received single dose of RO7020531, 10 mg, orally on Day 1.
|
Part 1 SAD: Cohort 3
n=5 Participants
HVs received single dose of RO7020531, 20 mg, orally on Day 1.
|
Part 1 SAD: Cohort 4
n=15 Participants
HVs received single dose of RO7020531, 40 mg, orally on Day 1.
|
Part 1 SAD: Cohort 5
HVs received single dose of RO7020531, 60 mg, orally on Day 1.
|
Part 1 SAD: Cohort 6
HVs received single dose of RO7020531, 100 mg, orally on Day 1.
|
Part 1 SAD: Cohort 7
HVs received single dose of RO7020531, 140 mg, orally on Day 1.
|
Part 1 SAD: Cohort 8
HVs received single dose of RO7020531, 170 mg, orally on Day 1.
|
Part 1 MAD: Cohort 2
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 2
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Blood Glucose, Fasting - High
|
16.7 percentage of participants
|
35.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
14.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Protein, Total - High
|
0 percentage of participants
|
6.7 percentage of participants
|
12.5 percentage of participants
|
20.0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
SGPT/ALT - High
|
16.7 percentage of participants
|
6.3 percentage of participants
|
0 percentage of participants
|
25.0 percentage of participants
|
36.4 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Eosinophil Absolute - High
|
0 percentage of participants
|
6.3 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Erythrocyte Mean Corpuscular HGB Concentration - Low
|
—
|
—
|
—
|
0 percentage of participants
|
6.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Erythrocyte Mean Corpuscular Volume - High
|
0 percentage of participants
|
6.7 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Hemoglobin - Low
|
—
|
—
|
—
|
0 percentage of participants
|
6.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Lymphocytes Absolute - Low
|
16.7 percentage of participants
|
25.0 percentage of participants
|
25.0 percentage of participants
|
20.0 percentage of participants
|
13.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Lymphocytes Absolute - High
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
20.0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Monocytes Absolute - Low
|
16.7 percentage of participants
|
8.3 percentage of participants
|
14.3 percentage of participants
|
0 percentage of participants
|
26.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Monocytes Absolute - High
|
16.7 percentage of participants
|
6.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Neutrophils, Total, Absolute - Low
|
20.0 percentage of participants
|
35.7 percentage of participants
|
62.5 percentage of participants
|
0 percentage of participants
|
46.2 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Neutrophils, Total, Absolute - High
|
0 percentage of participants
|
6.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Platelet - Low
|
0 percentage of participants
|
18.8 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
6.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Red Blood Cell Count - Low
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
6.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Reticulocytes, Pct - High
|
0 percentage of participants
|
6.3 percentage of participants
|
12.5 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
White Blood Cell Count - Low
|
20.0 percentage of participants
|
46.2 percentage of participants
|
42.9 percentage of participants
|
20.0 percentage of participants
|
50.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
White Blood Cell Count - High
|
0 percentage of participants
|
6.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Bicarbonate CO2 - Low
|
0 percentage of participants
|
6.3 percentage of participants
|
12.5 percentage of participants
|
20.0 percentage of participants
|
7.1 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Bicarbonate CO2 - High
|
0 percentage of participants
|
6.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
6.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Bilirubin - High
|
0 percentage of participants
|
6.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
7.1 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Blood Glucose, Fasting - Low
|
16.7 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
20.0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Blood Urea Nitrogen - High
|
33.3 percentage of participants
|
26.7 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
6.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Calcium - Low
|
0 percentage of participants
|
6.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
6.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Chloride - Low
|
0 percentage of participants
|
13.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Chloride - High
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
20.0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Cholesterol - High
|
0 percentage of participants
|
14.3 percentage of participants
|
25.0 percentage of participants
|
80.0 percentage of participants
|
12.5 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Creatinine - High
|
0 percentage of participants
|
7.1 percentage of participants
|
0 percentage of participants
|
20.0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Cystatin C - High
|
20.0 percentage of participants
|
26.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
6.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Indirect Bilirubin - Low
|
16.7 percentage of participants
|
18.8 percentage of participants
|
0 percentage of participants
|
50.0 percentage of participants
|
53.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Indirect Bilirubin - High
|
0 percentage of participants
|
6.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
7.1 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Phosphorus - Low
|
0 percentage of participants
|
43.8 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
6.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Phosphorus - High
|
0 percentage of participants
|
6.3 percentage of participants
|
0 percentage of participants
|
20.0 percentage of participants
|
7.1 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Potassium - High
|
33.3 percentage of participants
|
6.3 percentage of participants
|
12.5 percentage of participants
|
40.0 percentage of participants
|
13.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Protein, Total - Low
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
6.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
SGOT/AST - High
|
0 percentage of participants
|
6.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
42.9 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Sodium - High
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
20.0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Triglycerides, Fasting - High
|
16.7 percentage of participants
|
50.0 percentage of participants
|
12.5 percentage of participants
|
50.0 percentage of participants
|
14.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Uric Acid - High
|
0 percentage of participants
|
6.7 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
14.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Activated Partial Thromboplastin Time - High
|
0 percentage of participants
|
6.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
13.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
International Normalized Ratio - High
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
14.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Chronic Hepatitis B Participants With Laboratory Abnormalities Based on Hematology, Clinical Chemistry, Coagulation and Urinalysis Test Results
Prothrombin Time - High
|
20.0 percentage of participants
|
30.8 percentage of participants
|
14.3 percentage of participants
|
66.7 percentage of participants
|
41.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From randomization up to Day 8Population: Safety analysis population included all HVs who had received at least 1 dose of study drug. Number analyzed is the number of participants with data available for analysis at the specified time point.
Triplicate 12-lead ECGs were obtained after the participant has been in a supine position for at least 10 minutes. Clinically significant RO7020531-related changes included confirmation of mean QTc 500 milliseconds (msec) or 60 msec longer than the pre-dose baseline.
Outcome measures
| Measure |
Part 1 Cohorts 1-8 SAD: Placebo
n=16 Participants
In SAD Cohorts 1-8, sixteen HVs, two in each cohort, received a single dose of RO7020531 matching placebo, on Day 1.
|
Part 1 SAD: Cohort 1
n=8 Participants
HVs received single dose of RO7020531, 3 mg, orally on Day 1.
|
Part 1 SAD: Cohort 2
n=8 Participants
HVs received single dose of RO7020531, 10 mg, orally on Day 1.
|
Part 1 SAD: Cohort 3
n=8 Participants
HVs received single dose of RO7020531, 20 mg, orally on Day 1.
|
Part 1 SAD: Cohort 4
n=8 Participants
HVs received single dose of RO7020531, 40 mg, orally on Day 1.
|
Part 1 SAD: Cohort 5
n=8 Participants
HVs received single dose of RO7020531, 60 mg, orally on Day 1.
|
Part 1 SAD: Cohort 6
n=8 Participants
HVs received single dose of RO7020531, 100 mg, orally on Day 1.
|
Part 1 SAD: Cohort 7
n=8 Participants
HVs received single dose of RO7020531, 140 mg, orally on Day 1.
|
Part 1 SAD: Cohort 8
n=8 Participants
HVs received single dose of RO7020531, 170 mg, orally on Day 1.
|
Part 1 MAD: Cohort 2
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 2
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters
Average QTcF (12-Lead Trip.) - High
|
0 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters
Average Heart Rate (12-Lead Trip.) - Low
|
6.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters
Average Heart Rate (12-Lead Trip.) - High
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters
Average PR (12-Lead Trip.) - Low
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
14.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters
Average PR (12-Lead Trip.) - High
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of SAD Participants With Abnormalities in Electrocardiograph (ECG) Parameters
Average QRS (12-Lead Trip.) - High
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From randomization up to Day 20Population: Safety analysis population included all HVs who had received at least 1 dose of study drug. Number analyzed is the number of participants with data available for analysis at the specified time point.
Triplicate 12-lead ECGs were obtained after the participants has been in a supine position for at least 10 minutes. Clinically significant RO7020531-related changes included confirmation of mean QTc 500 msec or 60 msec longer than the pre-dose baseline.
Outcome measures
| Measure |
Part 1 Cohorts 1-8 SAD: Placebo
n=6 Participants
In SAD Cohorts 1-8, sixteen HVs, two in each cohort, received a single dose of RO7020531 matching placebo, on Day 1.
|
Part 1 SAD: Cohort 1
n=8 Participants
HVs received single dose of RO7020531, 3 mg, orally on Day 1.
|
Part 1 SAD: Cohort 2
n=8 Participants
HVs received single dose of RO7020531, 10 mg, orally on Day 1.
|
Part 1 SAD: Cohort 3
n=8 Participants
HVs received single dose of RO7020531, 20 mg, orally on Day 1.
|
Part 1 SAD: Cohort 4
HVs received single dose of RO7020531, 40 mg, orally on Day 1.
|
Part 1 SAD: Cohort 5
HVs received single dose of RO7020531, 60 mg, orally on Day 1.
|
Part 1 SAD: Cohort 6
HVs received single dose of RO7020531, 100 mg, orally on Day 1.
|
Part 1 SAD: Cohort 7
HVs received single dose of RO7020531, 140 mg, orally on Day 1.
|
Part 1 SAD: Cohort 8
HVs received single dose of RO7020531, 170 mg, orally on Day 1.
|
Part 1 MAD: Cohort 2
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 2
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Percentage of MAD Participants With Abnormalities in ECG Parameters
Average PR (12-Lead Trip.) - Low
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of MAD Participants With Abnormalities in ECG Parameters
Average PR (12-Lead Trip.) - High
|
0 percentage of participants
|
14.3 percentage of participants
|
14.3 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From randomization up to Week 12Population: Safety analysis population included all participants who had received at least 1 dose of study drug. Number analyzed is the number of participants with data available for analysis at the specified time point.
Triplicate 12-lead ECGs were obtained after the participant has been in a supine position for at least 10 minutes. Clinically significant RO7020531-related changes included confirmation of mean QTc 500 msec or 60 msec longer than the pre-dose baseline.
Outcome measures
| Measure |
Part 1 Cohorts 1-8 SAD: Placebo
n=6 Participants
In SAD Cohorts 1-8, sixteen HVs, two in each cohort, received a single dose of RO7020531 matching placebo, on Day 1.
|
Part 1 SAD: Cohort 1
n=16 Participants
HVs received single dose of RO7020531, 3 mg, orally on Day 1.
|
Part 1 SAD: Cohort 2
n=8 Participants
HVs received single dose of RO7020531, 10 mg, orally on Day 1.
|
Part 1 SAD: Cohort 3
n=5 Participants
HVs received single dose of RO7020531, 20 mg, orally on Day 1.
|
Part 1 SAD: Cohort 4
n=15 Participants
HVs received single dose of RO7020531, 40 mg, orally on Day 1.
|
Part 1 SAD: Cohort 5
HVs received single dose of RO7020531, 60 mg, orally on Day 1.
|
Part 1 SAD: Cohort 6
HVs received single dose of RO7020531, 100 mg, orally on Day 1.
|
Part 1 SAD: Cohort 7
HVs received single dose of RO7020531, 140 mg, orally on Day 1.
|
Part 1 SAD: Cohort 8
HVs received single dose of RO7020531, 170 mg, orally on Day 1.
|
Part 1 MAD: Cohort 2
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 2
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in ECG Parameters
Average QTcF (12-Lead Trip.) - Low
|
0 percentage of participants
|
6.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in ECG Parameters
Average Heart Rate (12-Lead Trip.) - High
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
6.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in ECG Parameters
Average PR (12-Lead Trip.) - Low
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
6.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in ECG Parameters
Average PR (12-Lead Trip.) - High
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
20.0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in ECG Parameters
Average QTcF (12-Lead Trip.) - High
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
7.1 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From randomization up to Day 8Population: Safety analysis population included all HVs who had received at least 1 dose of study drug. Number analyzed is the number of participants with data available for analysis at the specified time point.
Vital signs include blood pressure, pulse rate, respiratory rate and body temperature. Blood pressure, respiratory rate and pulse rate were obtained after the participant had been in a supine or sitting position for at least 5 minutes. Blood pressure measurement were performed in triplicate (can be as short as 20 second to 1 minute interval between measurements).
Outcome measures
| Measure |
Part 1 Cohorts 1-8 SAD: Placebo
n=16 Participants
In SAD Cohorts 1-8, sixteen HVs, two in each cohort, received a single dose of RO7020531 matching placebo, on Day 1.
|
Part 1 SAD: Cohort 1
n=8 Participants
HVs received single dose of RO7020531, 3 mg, orally on Day 1.
|
Part 1 SAD: Cohort 2
n=8 Participants
HVs received single dose of RO7020531, 10 mg, orally on Day 1.
|
Part 1 SAD: Cohort 3
n=8 Participants
HVs received single dose of RO7020531, 20 mg, orally on Day 1.
|
Part 1 SAD: Cohort 4
n=8 Participants
HVs received single dose of RO7020531, 40 mg, orally on Day 1.
|
Part 1 SAD: Cohort 5
n=8 Participants
HVs received single dose of RO7020531, 60 mg, orally on Day 1.
|
Part 1 SAD: Cohort 6
n=8 Participants
HVs received single dose of RO7020531, 100 mg, orally on Day 1.
|
Part 1 SAD: Cohort 7
n=8 Participants
HVs received single dose of RO7020531, 140 mg, orally on Day 1.
|
Part 1 SAD: Cohort 8
n=8 Participants
HVs received single dose of RO7020531, 170 mg, orally on Day 1.
|
Part 1 MAD: Cohort 2
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 2
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs
Pulse Rate - High
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs
Average Diastolic BP - High
|
0 percentage of participants
|
12.5 percentage of participants
|
25.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs
Average Systolic BP - High
|
6.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
12.5 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs
Pulse Rate - Low
|
6.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs
Respiratory Rate - High
|
26.7 percentage of participants
|
0 percentage of participants
|
28.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
25.0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs
Temperature - Low
|
71.4 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
—
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
80.0 percentage of participants
|
40.0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of SAD Participants With Abnormalities in Vital Signs
Temperature - High
|
12.5 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
25.0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From randomization up to Day 20Population: Safety analysis population included all HVs who had received at least 1 dose of study drug. Number analyzed is the number of participants with data available for analysis at the specified time point.
Vital signs include blood pressure, pulse rate, respiratory rate and body temperature. Blood pressure, respiratory rate and pulse rate were obtained after the participant had been in a supine or sitting position for at least 5 minutes. Blood pressure measurement were performed in triplicate (can be as short as 20 second to 1 minute interval between measurements).
Outcome measures
| Measure |
Part 1 Cohorts 1-8 SAD: Placebo
n=6 Participants
In SAD Cohorts 1-8, sixteen HVs, two in each cohort, received a single dose of RO7020531 matching placebo, on Day 1.
|
Part 1 SAD: Cohort 1
n=8 Participants
HVs received single dose of RO7020531, 3 mg, orally on Day 1.
|
Part 1 SAD: Cohort 2
n=8 Participants
HVs received single dose of RO7020531, 10 mg, orally on Day 1.
|
Part 1 SAD: Cohort 3
n=8 Participants
HVs received single dose of RO7020531, 20 mg, orally on Day 1.
|
Part 1 SAD: Cohort 4
HVs received single dose of RO7020531, 40 mg, orally on Day 1.
|
Part 1 SAD: Cohort 5
HVs received single dose of RO7020531, 60 mg, orally on Day 1.
|
Part 1 SAD: Cohort 6
HVs received single dose of RO7020531, 100 mg, orally on Day 1.
|
Part 1 SAD: Cohort 7
HVs received single dose of RO7020531, 140 mg, orally on Day 1.
|
Part 1 SAD: Cohort 8
HVs received single dose of RO7020531, 170 mg, orally on Day 1.
|
Part 1 MAD: Cohort 2
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 2
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Percentage of MAD Participants With Abnormalities in Vital Signs
Average Diastolic BP - High
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of MAD Participants With Abnormalities in Vital Signs
Average Systolic BP - High
|
0 percentage of participants
|
25.0 percentage of participants
|
12.5 percentage of participants
|
12.5 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of MAD Participants With Abnormalities in Vital Signs
Pulse Rate - High
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of MAD Participants With Abnormalities in Vital Signs
Respiratory Rate - High
|
33.3 percentage of participants
|
25.0 percentage of participants
|
37.5 percentage of participants
|
50.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of MAD Participants With Abnormalities in Vital Signs
Temperature - Low
|
100.0 percentage of participants
|
100.0 percentage of participants
|
75.0 percentage of participants
|
50.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of MAD Participants With Abnormalities in Vital Signs
Temperature - High
|
0 percentage of participants
|
0 percentage of participants
|
25.0 percentage of participants
|
37.5 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From randomization up to Week 12Population: Safety analysis population included all participants who had received at least 1 dose of study drug. Number analyzed is the number of participants with data available for analysis at the specified time point.
Vital signs include blood pressure, pulse rate, respiratory rate and body temperature. Blood pressure, respiratory rate and pulse rate were obtained after the participant had been in a supine or sitting position for at least 5 minutes. Blood pressure measurement were performed in triplicate (can be as short as 20 second to 1 minute interval between measurements).
Outcome measures
| Measure |
Part 1 Cohorts 1-8 SAD: Placebo
n=6 Participants
In SAD Cohorts 1-8, sixteen HVs, two in each cohort, received a single dose of RO7020531 matching placebo, on Day 1.
|
Part 1 SAD: Cohort 1
n=16 Participants
HVs received single dose of RO7020531, 3 mg, orally on Day 1.
|
Part 1 SAD: Cohort 2
n=8 Participants
HVs received single dose of RO7020531, 10 mg, orally on Day 1.
|
Part 1 SAD: Cohort 3
n=5 Participants
HVs received single dose of RO7020531, 20 mg, orally on Day 1.
|
Part 1 SAD: Cohort 4
n=15 Participants
HVs received single dose of RO7020531, 40 mg, orally on Day 1.
|
Part 1 SAD: Cohort 5
HVs received single dose of RO7020531, 60 mg, orally on Day 1.
|
Part 1 SAD: Cohort 6
HVs received single dose of RO7020531, 100 mg, orally on Day 1.
|
Part 1 SAD: Cohort 7
HVs received single dose of RO7020531, 140 mg, orally on Day 1.
|
Part 1 SAD: Cohort 8
HVs received single dose of RO7020531, 170 mg, orally on Day 1.
|
Part 1 MAD: Cohort 2
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 2
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in Vital Signs
Average Diastolic BP - High
|
33.3 percentage of participants
|
35.7 percentage of participants
|
12.5 percentage of participants
|
60.0 percentage of participants
|
6.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in Vital Signs
Average Systolic BP - High
|
50.0 percentage of participants
|
31.3 percentage of participants
|
12.5 percentage of participants
|
20.0 percentage of participants
|
6.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in Vital Signs
Pulse Rate - Low
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
6.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in Vital Signs
Pulse Rate - High
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
40.0 percentage of participants
|
40.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in Vital Signs
Respiratory Rate - High
|
16.7 percentage of participants
|
6.3 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
6.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in Vital Signs
Temperature - Low
|
—
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of Chronic Hepatitis B Participants With Abnormalities in Vital Signs
Temperature - High
|
0 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
20.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: SAD: Predose and 0.5, 1, 1.5 , 2, 3, 4, 6,8, 12,18, and 24hours post dose on Day 1; MAD: Predose and 0.25, 0.5, 1, 1.5, 2 , 3, 4, 6, 8, 12,18, and 24 hours post dose on Days 1 and 13Population: The Pharmacokinetic (PK) analysis population included all HVs randomized and adherent to the protocol. Number analyzed is the number of participants available at the specific timepoints.
Outcome measures
| Measure |
Part 1 Cohorts 1-8 SAD: Placebo
n=8 Participants
In SAD Cohorts 1-8, sixteen HVs, two in each cohort, received a single dose of RO7020531 matching placebo, on Day 1.
|
Part 1 SAD: Cohort 1
n=8 Participants
HVs received single dose of RO7020531, 3 mg, orally on Day 1.
|
Part 1 SAD: Cohort 2
n=8 Participants
HVs received single dose of RO7020531, 10 mg, orally on Day 1.
|
Part 1 SAD: Cohort 3
n=8 Participants
HVs received single dose of RO7020531, 20 mg, orally on Day 1.
|
Part 1 SAD: Cohort 4
n=8 Participants
HVs received single dose of RO7020531, 40 mg, orally on Day 1.
|
Part 1 SAD: Cohort 5
n=8 Participants
HVs received single dose of RO7020531, 60 mg, orally on Day 1.
|
Part 1 SAD: Cohort 6
n=8 Participants
HVs received single dose of RO7020531, 100 mg, orally on Day 1.
|
Part 1 SAD: Cohort 7
n=8 Participants
HVs received single dose of RO7020531, 140 mg, orally on Day 1.
|
Part 1 SAD: Cohort 8
n=8 Participants
HVs received single dose of RO7020531, 170 mg, orally on Day 1.
|
Part 1 MAD: Cohort 2
n=8 Participants
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
n=8 Participants
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 2
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Maximum Observed Plasma Concentration (Cmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD
RO7020531: Day 1
|
0.00 nanograms per milliliter (ng/mL)
Standard Deviation 0.00
|
0.00 nanograms per milliliter (ng/mL)
Standard Deviation 0.00
|
0.00 nanograms per milliliter (ng/mL)
Standard Deviation 0.00
|
0.00 nanograms per milliliter (ng/mL)
Standard Deviation 0.00
|
0.00 nanograms per milliliter (ng/mL)
Standard Deviation 0.00
|
0.00 nanograms per milliliter (ng/mL)
Standard Deviation 0.00
|
0.00 nanograms per milliliter (ng/mL)
Standard Deviation 0.00
|
0.00 nanograms per milliliter (ng/mL)
Standard Deviation 0.00
|
—
|
—
|
1.87 nanograms per milliliter (ng/mL)
Standard Deviation NA
Since only 1 participant is analyzed, Standard deviation (SD) was not calculated.
|
—
|
—
|
|
Part 1: Maximum Observed Plasma Concentration (Cmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD
RO7011785: Day 1
|
30.2 nanograms per milliliter (ng/mL)
Standard Deviation 10.4
|
115 nanograms per milliliter (ng/mL)
Standard Deviation 69.0
|
182 nanograms per milliliter (ng/mL)
Standard Deviation 71.4
|
508 nanograms per milliliter (ng/mL)
Standard Deviation 203
|
598 nanograms per milliliter (ng/mL)
Standard Deviation 218
|
1270 nanograms per milliliter (ng/mL)
Standard Deviation 505
|
1830 nanograms per milliliter (ng/mL)
Standard Deviation 238
|
1670 nanograms per milliliter (ng/mL)
Standard Deviation 654
|
1060 nanograms per milliliter (ng/mL)
Standard Deviation 428
|
1680 nanograms per milliliter (ng/mL)
Standard Deviation 735
|
2150 nanograms per milliliter (ng/mL)
Standard Deviation 746
|
—
|
—
|
|
Part 1: Maximum Observed Plasma Concentration (Cmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD
RO7011785: Day 13
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1100 nanograms per milliliter (ng/mL)
Standard Deviation 448
|
1470 nanograms per milliliter (ng/mL)
Standard Deviation 557
|
2100 nanograms per milliliter (ng/mL)
Standard Deviation 838
|
—
|
—
|
|
Part 1: Maximum Observed Plasma Concentration (Cmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD
RO7018822: Day 1
|
2.01 nanograms per milliliter (ng/mL)
Standard Deviation 1.12
|
8.96 nanograms per milliliter (ng/mL)
Standard Deviation 5.15
|
20.0 nanograms per milliliter (ng/mL)
Standard Deviation 16.0
|
52.3 nanograms per milliliter (ng/mL)
Standard Deviation 24.9
|
54.4 nanograms per milliliter (ng/mL)
Standard Deviation 32.1
|
101 nanograms per milliliter (ng/mL)
Standard Deviation 37.7
|
166 nanograms per milliliter (ng/mL)
Standard Deviation 79.3
|
189 nanograms per milliliter (ng/mL)
Standard Deviation 52.5
|
98.3 nanograms per milliliter (ng/mL)
Standard Deviation 42.3
|
144 nanograms per milliliter (ng/mL)
Standard Deviation 52.1
|
234 nanograms per milliliter (ng/mL)
Standard Deviation 163
|
—
|
—
|
|
Part 1: Maximum Observed Plasma Concentration (Cmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD
RO7018822: Day 13
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
77.7 nanograms per milliliter (ng/mL)
Standard Deviation 42.2
|
125 nanograms per milliliter (ng/mL)
Standard Deviation 47.6
|
220 nanograms per milliliter (ng/mL)
Standard Deviation 143
|
—
|
—
|
|
Part 1: Maximum Observed Plasma Concentration (Cmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD
RO7033805: Day 1
|
0.00 nanograms per milliliter (ng/mL)
Standard Deviation 0.00
|
0.00 nanograms per milliliter (ng/mL)
Standard Deviation 0.00
|
0.00 nanograms per milliliter (ng/mL)
Standard Deviation 0.00
|
0.00 nanograms per milliliter (ng/mL)
Standard Deviation 0.00
|
0.00 nanograms per milliliter (ng/mL)
Standard Deviation 0.00
|
0.00 nanograms per milliliter (ng/mL)
Standard Deviation 0.00
|
0.00 nanograms per milliliter (ng/mL)
Standard Deviation 0.00
|
0.285 nanograms per milliliter (ng/mL)
Standard Deviation 0.806
|
1.24 nanograms per milliliter (ng/mL)
Standard Deviation NA
Since only 1 participant is analyzed, SD was not calculated.
|
—
|
2.30 nanograms per milliliter (ng/mL)
Standard Deviation 0.339
|
—
|
—
|
|
Part 1: Maximum Observed Plasma Concentration (Cmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD
RO7033805: Day 13
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1.90 nanograms per milliliter (ng/mL)
Standard Deviation 0.600
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose and 0.25, 1, 2, 4, 6, 8, and 24 hours post dose on Days 1 and 41Population: The PK analysis population included all participants randomized and adherent to the protocol. Number analyzed is the number of participants available at the specific timepoints.
Outcome measures
| Measure |
Part 1 Cohorts 1-8 SAD: Placebo
n=16 Participants
In SAD Cohorts 1-8, sixteen HVs, two in each cohort, received a single dose of RO7020531 matching placebo, on Day 1.
|
Part 1 SAD: Cohort 1
n=15 Participants
HVs received single dose of RO7020531, 3 mg, orally on Day 1.
|
Part 1 SAD: Cohort 2
n=8 Participants
HVs received single dose of RO7020531, 10 mg, orally on Day 1.
|
Part 1 SAD: Cohort 3
HVs received single dose of RO7020531, 20 mg, orally on Day 1.
|
Part 1 SAD: Cohort 4
HVs received single dose of RO7020531, 40 mg, orally on Day 1.
|
Part 1 SAD: Cohort 5
HVs received single dose of RO7020531, 60 mg, orally on Day 1.
|
Part 1 SAD: Cohort 6
HVs received single dose of RO7020531, 100 mg, orally on Day 1.
|
Part 1 SAD: Cohort 7
HVs received single dose of RO7020531, 140 mg, orally on Day 1.
|
Part 1 SAD: Cohort 8
HVs received single dose of RO7020531, 170 mg, orally on Day 1.
|
Part 1 MAD: Cohort 2
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 2
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Cmax of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805
RO7033805: Day 41
|
1.51 ng/mL
Standard Deviation NA
Since only 1 participant is analyzed, SD was not calculated.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cmax of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805
RO7020531: Day 1
|
1.70 ng/mL
Standard Deviation NA
Since only 1 participant is analyzed, SD was not calculated.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cmax of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805
RO7011785: Day 1
|
1690 ng/mL
Standard Deviation 639
|
1500 ng/mL
Standard Deviation 668
|
1980 ng/mL
Standard Deviation 891
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cmax of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805
RO7011785: Day 41
|
1580 ng/mL
Standard Deviation 591
|
1430 ng/mL
Standard Deviation 457
|
1990 ng/mL
Standard Deviation 999
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cmax of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805
RO7018822: Day 1
|
167 ng/mL
Standard Deviation 93.2
|
203 ng/mL
Standard Deviation 110
|
218 ng/mL
Standard Deviation 113
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cmax of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805
RO7018822: Day 41
|
193 ng/mL
Standard Deviation 114
|
194 ng/mL
Standard Deviation 134
|
184 ng/mL
Standard Deviation 90.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cmax of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805
RO7033805: Day 1
|
—
|
1.43 ng/mL
Standard Deviation NA
Since only 1 participant is analyzed, SD was not calculated.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: SAD: Predose and 0.5, 1, 1.5 , 2, 3, 4, 6,8, 12,18, and 24hours post dose on Day 1; MAD: Predose and 0.25, 0.5, 1, 1.5, 2 , 3, 4, 6, 8, 12,18, and 24 hours post dose on Days 1 and 13Population: The PK analysis population included all HVs randomized and adherent to the protocol. Number analyzed is the number of participants available at the specific timepoints.
Outcome measures
| Measure |
Part 1 Cohorts 1-8 SAD: Placebo
n=8 Participants
In SAD Cohorts 1-8, sixteen HVs, two in each cohort, received a single dose of RO7020531 matching placebo, on Day 1.
|
Part 1 SAD: Cohort 1
n=8 Participants
HVs received single dose of RO7020531, 3 mg, orally on Day 1.
|
Part 1 SAD: Cohort 2
n=8 Participants
HVs received single dose of RO7020531, 10 mg, orally on Day 1.
|
Part 1 SAD: Cohort 3
n=8 Participants
HVs received single dose of RO7020531, 20 mg, orally on Day 1.
|
Part 1 SAD: Cohort 4
n=8 Participants
HVs received single dose of RO7020531, 40 mg, orally on Day 1.
|
Part 1 SAD: Cohort 5
n=8 Participants
HVs received single dose of RO7020531, 60 mg, orally on Day 1.
|
Part 1 SAD: Cohort 6
n=8 Participants
HVs received single dose of RO7020531, 100 mg, orally on Day 1.
|
Part 1 SAD: Cohort 7
n=8 Participants
HVs received single dose of RO7020531, 140 mg, orally on Day 1.
|
Part 1 SAD: Cohort 8
n=8 Participants
HVs received single dose of RO7020531, 170 mg, orally on Day 1.
|
Part 1 MAD: Cohort 2
n=8 Participants
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
n=8 Participants
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 2
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD
RO7020531: Day 1
|
0.00 hours (hr)
Interval 0.0 to 0.0
|
0.00 hours (hr)
Interval 0.0 to 0.0
|
0.00 hours (hr)
Interval 0.0 to 0.0
|
0.00 hours (hr)
Interval 0.0 to 0.0
|
0.00 hours (hr)
Interval 0.0 to 0.0
|
0.00 hours (hr)
Interval 0.0 to 0.0
|
0.00 hours (hr)
Interval 0.0 to 0.0
|
0.00 hours (hr)
Interval 0.0 to 0.0
|
—
|
—
|
0.25 hours (hr)
Interval 0.25 to 0.25
|
—
|
—
|
|
Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD
RO7018822: Day 1
|
0.50 hours (hr)
Interval 0.0 to 1.5
|
0.50 hours (hr)
Interval 0.5 to 1.5
|
0.50 hours (hr)
Interval 0.25 to 1.0
|
0.50 hours (hr)
Interval 0.5 to 1.5
|
0.50 hours (hr)
Interval 0.5 to 2.0
|
1.00 hours (hr)
Interval 0.5 to 2.0
|
0.75 hours (hr)
Interval 0.25 to 1.5
|
0.77 hours (hr)
Interval 0.5 to 2.0
|
0.75 hours (hr)
Interval 0.5 to 2.0
|
1.00 hours (hr)
Interval 0.5 to 1.52
|
0.52 hours (hr)
Interval 0.5 to 1.0
|
—
|
—
|
|
Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD
RO7011785: Day 1
|
0.75 hours (hr)
Interval 0.5 to 3.0
|
0.51 hours (hr)
Interval 0.5 to 1.5
|
1.00 hours (hr)
Interval 0.5 to 1.0
|
0.78 hours (hr)
Interval 0.5 to 1.08
|
0.75 hours (hr)
Interval 0.5 to 1.0
|
1.00 hours (hr)
Interval 0.5 to 2.0
|
1.00 hours (hr)
Interval 0.5 to 1.5
|
0.52 hours (hr)
Interval 0.5 to 1.5
|
1.00 hours (hr)
Interval 0.5 to 2.0
|
1.00 hours (hr)
Interval 0.5 to 1.52
|
0.76 hours (hr)
Interval 0.5 to 1.0
|
—
|
—
|
|
Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD
RO7011785: Day 13
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1.00 hours (hr)
Interval 0.5 to 1.0
|
1.00 hours (hr)
Interval 0.5 to 1.5
|
0.50 hours (hr)
Interval 0.5 to 1.5
|
—
|
—
|
|
Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD
RO7018822: Day 13
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1.00 hours (hr)
Interval 0.25 to 2.0
|
0.73 hours (hr)
Interval 0.5 to 1.0
|
0.50 hours (hr)
Interval 0.5 to 1.0
|
—
|
—
|
|
Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD
RO7033805: Day 1
|
0.00 hours (hr)
Interval 0.0 to 0.0
|
0.00 hours (hr)
Interval 0.0 to 0.0
|
0.00 hours (hr)
Interval 0.0 to 0.0
|
0.00 hours (hr)
Interval 0.0 to 0.0
|
0.00 hours (hr)
Interval 0.0 to 0.0
|
0.00 hours (hr)
Interval 0.0 to 0.0
|
0.00 hours (hr)
Interval 0.0 to 0.0
|
0.00 hours (hr)
Interval 0.0 to 0.0
|
0.50 hours (hr)
Interval 0.5 to 0.5
|
—
|
0.51 hours (hr)
Interval 0.5 to 0.52
|
—
|
—
|
|
Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD
RO7033805: Day 13
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.50 hours (hr)
Interval 0.5 to 0.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose and 0.25, 1, 2, 4, 6, 8, and 24 hours post dose on Days 1 and 41Population: The PK analysis population included all participants randomized and adherent to the protocol. Number analyzed is the number of participants available at the specific timepoints.
Outcome measures
| Measure |
Part 1 Cohorts 1-8 SAD: Placebo
n=16 Participants
In SAD Cohorts 1-8, sixteen HVs, two in each cohort, received a single dose of RO7020531 matching placebo, on Day 1.
|
Part 1 SAD: Cohort 1
n=15 Participants
HVs received single dose of RO7020531, 3 mg, orally on Day 1.
|
Part 1 SAD: Cohort 2
n=8 Participants
HVs received single dose of RO7020531, 10 mg, orally on Day 1.
|
Part 1 SAD: Cohort 3
HVs received single dose of RO7020531, 20 mg, orally on Day 1.
|
Part 1 SAD: Cohort 4
HVs received single dose of RO7020531, 40 mg, orally on Day 1.
|
Part 1 SAD: Cohort 5
HVs received single dose of RO7020531, 60 mg, orally on Day 1.
|
Part 1 SAD: Cohort 6
HVs received single dose of RO7020531, 100 mg, orally on Day 1.
|
Part 1 SAD: Cohort 7
HVs received single dose of RO7020531, 140 mg, orally on Day 1.
|
Part 1 SAD: Cohort 8
HVs received single dose of RO7020531, 170 mg, orally on Day 1.
|
Part 1 MAD: Cohort 2
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 2
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Tmax of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805
RO7020531: Day 1
|
0.25 hr
Interval 0.25 to 0.25
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Tmax of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805
RO7011785: Day 1
|
1.00 hr
Interval 0.25 to 2.0
|
1.00 hr
Interval 0.25 to 2.0
|
1.00 hr
Interval 0.92 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Tmax of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805
RO7011785: Day 41
|
1.040 hr
Interval 0.92 to 2.0
|
1.00 hr
Interval 0.92 to 2.0
|
1.00 hr
Interval 0.92 to 4.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Tmax of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805
RO7018822: Day 1
|
1.00 hr
Interval 0.25 to 2.0
|
1.00 hr
Interval 0.25 to 2.0
|
1.00 hr
Interval 0.25 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Tmax of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805
RO7018822: Day 41
|
1.00 hr
Interval 0.92 to 2.0
|
1.00 hr
Interval 0.25 to 2.0
|
1.00 hr
Interval 0.28 to 4.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Tmax of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805
RO7033805: Day 1
|
—
|
0.25 hr
Interval 0.25 to 0.25
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Tmax of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805
RO7033805: Day 41
|
1.00 hr
Interval 1.0 to 1.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: SAD: Predose and 0.5, 1, 1.5 , 2, 3, 4, 6,8, 12,18, and 24hours post dose on Day 1; MAD: Predose and 0.25, 0.5, 1, 1.5, 2 , 3, 4, 6, 8, 12,18, and 24 hours post dose on Days 1 and 13Population: The PK analysis population included all HVs randomized and adherent to the protocol. Number analyzed is the number of participants available at the specific timepoints.
Outcome measures
| Measure |
Part 1 Cohorts 1-8 SAD: Placebo
n=8 Participants
In SAD Cohorts 1-8, sixteen HVs, two in each cohort, received a single dose of RO7020531 matching placebo, on Day 1.
|
Part 1 SAD: Cohort 1
n=8 Participants
HVs received single dose of RO7020531, 3 mg, orally on Day 1.
|
Part 1 SAD: Cohort 2
n=8 Participants
HVs received single dose of RO7020531, 10 mg, orally on Day 1.
|
Part 1 SAD: Cohort 3
n=8 Participants
HVs received single dose of RO7020531, 20 mg, orally on Day 1.
|
Part 1 SAD: Cohort 4
n=8 Participants
HVs received single dose of RO7020531, 40 mg, orally on Day 1.
|
Part 1 SAD: Cohort 5
n=8 Participants
HVs received single dose of RO7020531, 60 mg, orally on Day 1.
|
Part 1 SAD: Cohort 6
n=8 Participants
HVs received single dose of RO7020531, 100 mg, orally on Day 1.
|
Part 1 SAD: Cohort 7
n=8 Participants
HVs received single dose of RO7020531, 140 mg, orally on Day 1.
|
Part 1 SAD: Cohort 8
n=8 Participants
HVs received single dose of RO7020531, 170 mg, orally on Day 1.
|
Part 1 MAD: Cohort 2
n=8 Participants
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
n=8 Participants
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 2
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD
RO7011785: Day 1
|
50.9 hours*nanogram per milliliter (h*ng/mL)
Standard Deviation 28.9
|
138 hours*nanogram per milliliter (h*ng/mL)
Standard Deviation 40.8
|
253 hours*nanogram per milliliter (h*ng/mL)
Standard Deviation 58.3
|
596 hours*nanogram per milliliter (h*ng/mL)
Standard Deviation 103
|
770 hours*nanogram per milliliter (h*ng/mL)
Standard Deviation 113
|
1600 hours*nanogram per milliliter (h*ng/mL)
Standard Deviation 228
|
2190 hours*nanogram per milliliter (h*ng/mL)
Standard Deviation 532
|
2690 hours*nanogram per milliliter (h*ng/mL)
Standard Deviation 857
|
1450 hours*nanogram per milliliter (h*ng/mL)
Standard Deviation 278
|
2250 hours*nanogram per milliliter (h*ng/mL)
Standard Deviation 838
|
2700 hours*nanogram per milliliter (h*ng/mL)
Standard Deviation 572
|
—
|
—
|
|
Part 1: Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD
RO7011785: Day 13
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1420 hours*nanogram per milliliter (h*ng/mL)
Standard Deviation 288
|
2150 hours*nanogram per milliliter (h*ng/mL)
Standard Deviation 734
|
2730 hours*nanogram per milliliter (h*ng/mL)
Standard Deviation 472
|
—
|
—
|
|
Part 1: Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD
RO7018822: Day 1
|
—
|
8.59 hours*nanogram per milliliter (h*ng/mL)
Standard Deviation 2.61
|
19.0 hours*nanogram per milliliter (h*ng/mL)
Standard Deviation 5.66
|
43.3 hours*nanogram per milliliter (h*ng/mL)
Standard Deviation 15.5
|
49.1 hours*nanogram per milliliter (h*ng/mL)
Standard Deviation 19.9
|
95.4 hours*nanogram per milliliter (h*ng/mL)
Standard Deviation 21.3
|
139 hours*nanogram per milliliter (h*ng/mL)
Standard Deviation 40.2
|
224 hours*nanogram per milliliter (h*ng/mL)
Standard Deviation 81.6
|
97.4 hours*nanogram per milliliter (h*ng/mL)
Standard Deviation 32.2
|
164 hours*nanogram per milliliter (h*ng/mL)
Standard Deviation 53.6
|
231 hours*nanogram per milliliter (h*ng/mL)
Standard Deviation 110
|
—
|
—
|
|
Part 1: Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD
RO7018822: Day 13
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
84.5 hours*nanogram per milliliter (h*ng/mL)
Standard Deviation 24.0
|
158 hours*nanogram per milliliter (h*ng/mL)
Standard Deviation 42.1
|
216 hours*nanogram per milliliter (h*ng/mL)
Standard Deviation 71.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose and 0.25, 1, 2, 4, 6, 8, and 24 hours post dose on Days 1 and 41Population: The PK analysis population included all participants randomized and adherent to the protocol. Number analyzed is the number of participants available at the specific timepoints.
Outcome measures
| Measure |
Part 1 Cohorts 1-8 SAD: Placebo
n=16 Participants
In SAD Cohorts 1-8, sixteen HVs, two in each cohort, received a single dose of RO7020531 matching placebo, on Day 1.
|
Part 1 SAD: Cohort 1
n=15 Participants
HVs received single dose of RO7020531, 3 mg, orally on Day 1.
|
Part 1 SAD: Cohort 2
n=8 Participants
HVs received single dose of RO7020531, 10 mg, orally on Day 1.
|
Part 1 SAD: Cohort 3
HVs received single dose of RO7020531, 20 mg, orally on Day 1.
|
Part 1 SAD: Cohort 4
HVs received single dose of RO7020531, 40 mg, orally on Day 1.
|
Part 1 SAD: Cohort 5
HVs received single dose of RO7020531, 60 mg, orally on Day 1.
|
Part 1 SAD: Cohort 6
HVs received single dose of RO7020531, 100 mg, orally on Day 1.
|
Part 1 SAD: Cohort 7
HVs received single dose of RO7020531, 140 mg, orally on Day 1.
|
Part 1 SAD: Cohort 8
HVs received single dose of RO7020531, 170 mg, orally on Day 1.
|
Part 1 MAD: Cohort 2
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 2
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: AUCinf of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805
RO7011785: Day 1
|
2770 h*ng/mL
Standard Deviation 968
|
2430 h*ng/mL
Standard Deviation 765
|
3060 h*ng/mL
Standard Deviation 1030
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: AUCinf of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805
RO7011785: Day 41
|
2740 h*ng/mL
Standard Deviation 762
|
2500 h*ng/mL
Standard Deviation 655
|
2960 h*ng/mL
Standard Deviation 909
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: AUCinf of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805
RO7018822: Day 1
|
338 h*ng/mL
Standard Deviation 147
|
326 h*ng/mL
Standard Deviation 139
|
374 h*ng/mL
Standard Deviation 261
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: AUCinf of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805
RO7018822: Day 41
|
498 h*ng/mL
Standard Deviation 176
|
482 h*ng/mL
Standard Deviation 249
|
327 h*ng/mL
Standard Deviation 105
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: SAD: Predose and 0.5, 1, 1.5 , 2, 3, 4, 6,8, 12,18, and 24hours post dose on Day 1; MAD: Predose and 0.25, 0.5, 1, 1.5, 2 , 3, 4, 6, 8, 12,18, and 24 hours post dose on Days 1 and 13Population: The PK analysis population included all HVs randomized and adherent to the protocol. Number analyzed is the number of participants available at the specific timepoints.
Outcome measures
| Measure |
Part 1 Cohorts 1-8 SAD: Placebo
n=8 Participants
In SAD Cohorts 1-8, sixteen HVs, two in each cohort, received a single dose of RO7020531 matching placebo, on Day 1.
|
Part 1 SAD: Cohort 1
n=8 Participants
HVs received single dose of RO7020531, 3 mg, orally on Day 1.
|
Part 1 SAD: Cohort 2
n=8 Participants
HVs received single dose of RO7020531, 10 mg, orally on Day 1.
|
Part 1 SAD: Cohort 3
n=8 Participants
HVs received single dose of RO7020531, 20 mg, orally on Day 1.
|
Part 1 SAD: Cohort 4
n=8 Participants
HVs received single dose of RO7020531, 40 mg, orally on Day 1.
|
Part 1 SAD: Cohort 5
n=8 Participants
HVs received single dose of RO7020531, 60 mg, orally on Day 1.
|
Part 1 SAD: Cohort 6
n=8 Participants
HVs received single dose of RO7020531, 100 mg, orally on Day 1.
|
Part 1 SAD: Cohort 7
n=8 Participants
HVs received single dose of RO7020531, 140 mg, orally on Day 1.
|
Part 1 SAD: Cohort 8
n=8 Participants
HVs received single dose of RO7020531, 170 mg, orally on Day 1.
|
Part 1 MAD: Cohort 2
n=8 Participants
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
n=8 Participants
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 2
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUClast) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD
RO7020531: Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.234 h*ng/mL
Standard Deviation NA
Since only 1 participant is analyzed, SD was not calculated.
|
—
|
—
|
|
Part 1: Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUClast) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD
RO7011785: Day 1
|
48.2 h*ng/mL
Standard Deviation 27.3
|
135 h*ng/mL
Standard Deviation 40.1
|
249 h*ng/mL
Standard Deviation 58.8
|
587 h*ng/mL
Standard Deviation 104
|
763 h*ng/mL
Standard Deviation 114
|
1590 h*ng/mL
Standard Deviation 227
|
2180 h*ng/mL
Standard Deviation 533
|
2680 h*ng/mL
Standard Deviation 857
|
1440 h*ng/mL
Standard Deviation 276
|
2240 h*ng/mL
Standard Deviation 837
|
2690 h*ng/mL
Standard Deviation 573
|
—
|
—
|
|
Part 1: Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUClast) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD
RO7011785: Day 13
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1410 h*ng/mL
Standard Deviation 288
|
2150 h*ng/mL
Standard Deviation 733
|
2720 h*ng/mL
Standard Deviation 472
|
—
|
—
|
|
Part 1: Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUClast) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD
RO7018822: Day 1
|
1.43 h*ng/mL
Standard Deviation 1.47
|
6.73 h*ng/mL
Standard Deviation 2.81
|
16.4 h*ng/mL
Standard Deviation 5.96
|
41.6 h*ng/mL
Standard Deviation 15.5
|
48.5 h*ng/mL
Standard Deviation 19.1
|
93.8 h*ng/mL
Standard Deviation 21.7
|
143 h*ng/mL
Standard Deviation 41.2
|
222 h*ng/mL
Standard Deviation 81.6
|
95.9 h*ng/mL
Standard Deviation 32.3
|
161 h*ng/mL
Standard Deviation 52.9
|
228 h*ng/mL
Standard Deviation 109
|
—
|
—
|
|
Part 1: Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUClast) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD
RO7018822: Day 13
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
80.6 h*ng/mL
Standard Deviation 23.5
|
154 h*ng/mL
Standard Deviation 39.7
|
210 h*ng/mL
Standard Deviation 64.9
|
—
|
—
|
|
Part 1: Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUClast) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD
RO7033805: Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.285 h*ng/mL
Standard Deviation NA
Since only 1 participant is analyzed, SD was not calculated.
|
0.155 h*ng/mL
Standard Deviation NA
Since only 1 participant is analyzed, SD was not calculated.
|
—
|
0.434 h*ng/mL
Standard Deviation 0.224
|
—
|
—
|
|
Part 1: Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUClast) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD
RO7033805: Day 13
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.316 h*ng/mL
Standard Deviation 0.155
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose and 0.25, 1, 2, 4, 6, 8, and 24 hours post dose on Days 1 and 41Population: The PK analysis population included all participants randomized and adherent to the protocol. Number analyzed is the number of participants available at the specific timepoints.
Outcome measures
| Measure |
Part 1 Cohorts 1-8 SAD: Placebo
n=16 Participants
In SAD Cohorts 1-8, sixteen HVs, two in each cohort, received a single dose of RO7020531 matching placebo, on Day 1.
|
Part 1 SAD: Cohort 1
n=15 Participants
HVs received single dose of RO7020531, 3 mg, orally on Day 1.
|
Part 1 SAD: Cohort 2
n=8 Participants
HVs received single dose of RO7020531, 10 mg, orally on Day 1.
|
Part 1 SAD: Cohort 3
HVs received single dose of RO7020531, 20 mg, orally on Day 1.
|
Part 1 SAD: Cohort 4
HVs received single dose of RO7020531, 40 mg, orally on Day 1.
|
Part 1 SAD: Cohort 5
HVs received single dose of RO7020531, 60 mg, orally on Day 1.
|
Part 1 SAD: Cohort 6
HVs received single dose of RO7020531, 100 mg, orally on Day 1.
|
Part 1 SAD: Cohort 7
HVs received single dose of RO7020531, 140 mg, orally on Day 1.
|
Part 1 SAD: Cohort 8
HVs received single dose of RO7020531, 170 mg, orally on Day 1.
|
Part 1 MAD: Cohort 2
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 2
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: AUClast of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805
RO7011785: Day 1
|
2820 h*ng/mL
Standard Deviation 979
|
2400 h*ng/mL
Standard Deviation 762
|
3030 h*ng/mL
Standard Deviation 1040
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: AUClast of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805
RO7020531: Day 1
|
0.213 h*ng/mL
Standard Deviation NA
Since only 1 participant is analyzed, SD was not calculated.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: AUClast of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805
RO7011785: Day 41
|
2730 h*ng/mL
Standard Deviation 771
|
2470 h*ng/mL
Standard Deviation 653
|
2930 h*ng/mL
Standard Deviation 915
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: AUClast of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805
RO7018822: Day 1
|
220 h*ng/mL
Standard Deviation 124
|
253 h*ng/mL
Standard Deviation 127
|
255 h*ng/mL
Standard Deviation 134
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: AUClast of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805
RO7018822: Day 41
|
297 h*ng/mL
Standard Deviation 214
|
301 h*ng/mL
Standard Deviation 228
|
243 h*ng/mL
Standard Deviation 87.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: AUClast of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805
RO7033805: Day 1
|
—
|
0.179 h*ng/mL
Standard Deviation NA
Since only 1 participant is analyzed, SD was not calculated.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: AUClast of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805
RO7033805: Day 41
|
0.566 h*ng/mL
Standard Deviation NA
Since only 1 participant is analyzed, SD was not calculated.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: SAD: Predose and 0.5, 1, 1.5 , 2, 3, 4, 6,8, 12,18, and 24hours post dose on Day 1; MAD: Predose and 0.25, 0.5, 1, 1.5, 2 , 3, 4, 6, 8, 12,18, and 24 hours post dose on Days 1 and 13Population: The PK analysis population included all HVs randomized and adherent to the protocol. Number analyzed is the number of participants available at the specific timepoints.
Outcome measures
| Measure |
Part 1 Cohorts 1-8 SAD: Placebo
n=8 Participants
In SAD Cohorts 1-8, sixteen HVs, two in each cohort, received a single dose of RO7020531 matching placebo, on Day 1.
|
Part 1 SAD: Cohort 1
n=8 Participants
HVs received single dose of RO7020531, 3 mg, orally on Day 1.
|
Part 1 SAD: Cohort 2
n=8 Participants
HVs received single dose of RO7020531, 10 mg, orally on Day 1.
|
Part 1 SAD: Cohort 3
n=8 Participants
HVs received single dose of RO7020531, 20 mg, orally on Day 1.
|
Part 1 SAD: Cohort 4
n=8 Participants
HVs received single dose of RO7020531, 40 mg, orally on Day 1.
|
Part 1 SAD: Cohort 5
n=8 Participants
HVs received single dose of RO7020531, 60 mg, orally on Day 1.
|
Part 1 SAD: Cohort 6
n=8 Participants
HVs received single dose of RO7020531, 100 mg, orally on Day 1.
|
Part 1 SAD: Cohort 7
n=8 Participants
HVs received single dose of RO7020531, 140 mg, orally on Day 1.
|
Part 1 SAD: Cohort 8
n=8 Participants
HVs received single dose of RO7020531, 170 mg, orally on Day 1.
|
Part 1 MAD: Cohort 2
n=8 Participants
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
n=8 Participants
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 2
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Half Life (t1/2) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD
RO7011785: Day 1
|
1.11 hr
Standard Deviation 0.370
|
1.56 hr
Standard Deviation 0.319
|
1.81 hr
Standard Deviation 0.506
|
2.78 hr
Standard Deviation 0.479
|
2.82 hr
Standard Deviation 0.599
|
3.35 hr
Standard Deviation 0.573
|
3.26 hr
Standard Deviation 0.254
|
3.39 hr
Standard Deviation 0.616
|
3.23 hr
Standard Deviation 0.635
|
2.80 hr
Standard Deviation 0.538
|
3.00 hr
Standard Deviation 0.692
|
—
|
—
|
|
Part 1: Half Life (t1/2) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD
RO7011785: Day 13
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
3.63 hr
Standard Deviation 0.740
|
3.23 hr
Standard Deviation 0.528
|
3.45 hr
Standard Deviation 1.12
|
—
|
—
|
|
Part 1: Half Life (t1/2) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD
RO7018822: Day 1
|
—
|
0.610 hr
Standard Deviation 0.0986
|
0.655 hr
Standard Deviation 0.276
|
0.579 hr
Standard Deviation 0.144
|
0.567 hr
Standard Deviation 0.190
|
0.585 hr
Standard Deviation 0.0780
|
0.564 hr
Standard Deviation 0.0827
|
0.645 hr
Standard Deviation 0.137
|
0.548 hr
Standard Deviation 0.111
|
0.586 hr
Standard Deviation 0.0507
|
0.601 hr
Standard Deviation 0.113
|
—
|
—
|
|
Part 1: Half Life (t1/2) of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805: SAD and MAD
RO7018822: Day 13
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.578 hr
Standard Deviation 0.0528
|
0.620 hr
Standard Deviation 0.0812
|
0.744 hr
Standard Deviation 0.204
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose and 0.25, 1, 2, 4, 6, 8, and 24 hours post dose on Days 1 and 41Population: The PK analysis population included all participants randomized and adherent to the protocol. Number analyzed is the number of participants available at the specific timepoints.
Outcome measures
| Measure |
Part 1 Cohorts 1-8 SAD: Placebo
n=16 Participants
In SAD Cohorts 1-8, sixteen HVs, two in each cohort, received a single dose of RO7020531 matching placebo, on Day 1.
|
Part 1 SAD: Cohort 1
n=15 Participants
HVs received single dose of RO7020531, 3 mg, orally on Day 1.
|
Part 1 SAD: Cohort 2
n=8 Participants
HVs received single dose of RO7020531, 10 mg, orally on Day 1.
|
Part 1 SAD: Cohort 3
HVs received single dose of RO7020531, 20 mg, orally on Day 1.
|
Part 1 SAD: Cohort 4
HVs received single dose of RO7020531, 40 mg, orally on Day 1.
|
Part 1 SAD: Cohort 5
HVs received single dose of RO7020531, 60 mg, orally on Day 1.
|
Part 1 SAD: Cohort 6
HVs received single dose of RO7020531, 100 mg, orally on Day 1.
|
Part 1 SAD: Cohort 7
HVs received single dose of RO7020531, 140 mg, orally on Day 1.
|
Part 1 SAD: Cohort 8
HVs received single dose of RO7020531, 170 mg, orally on Day 1.
|
Part 1 MAD: Cohort 2
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 2
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: t1/2 of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805
RO7011785: Day 1
|
3.09 hr
Standard Deviation 0.982
|
2.63 hr
Standard Deviation 1.19
|
3.06 hr
Standard Deviation 0.934
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: t1/2 of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805
RO7011785: Day 41
|
3.09 hr
Standard Deviation 0.697
|
2.77 hr
Standard Deviation 1.19
|
2.90 hr
Standard Deviation 0.980
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: t1/2 of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805
RO7018822: Day 1
|
1.19 hr
Standard Deviation 0.886
|
0.665 hr
Standard Deviation 0.0431
|
0.648 hr
Standard Deviation 0.0317
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: t1/2 of RO7020531 and Its Metabolites Including RO7011785, RO7018822 and RO7033805
RO7018822: Day 41
|
0.776 hr
Standard Deviation 0.146
|
0.714 hr
Standard Deviation 0.112
|
0.720 hr
Standard Deviation 0.774
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 to 24 hrs Postdose on Day 1Population: The PK analysis population included all HVs randomized and adherent to the protocol. Number analyzed is the number of participants available at the specific timepoints.
Total amount of the study drug and metabolites recovered in urine was reported.
Outcome measures
| Measure |
Part 1 Cohorts 1-8 SAD: Placebo
n=8 Participants
In SAD Cohorts 1-8, sixteen HVs, two in each cohort, received a single dose of RO7020531 matching placebo, on Day 1.
|
Part 1 SAD: Cohort 1
n=8 Participants
HVs received single dose of RO7020531, 3 mg, orally on Day 1.
|
Part 1 SAD: Cohort 2
n=8 Participants
HVs received single dose of RO7020531, 10 mg, orally on Day 1.
|
Part 1 SAD: Cohort 3
n=8 Participants
HVs received single dose of RO7020531, 20 mg, orally on Day 1.
|
Part 1 SAD: Cohort 4
n=8 Participants
HVs received single dose of RO7020531, 40 mg, orally on Day 1.
|
Part 1 SAD: Cohort 5
n=8 Participants
HVs received single dose of RO7020531, 60 mg, orally on Day 1.
|
Part 1 SAD: Cohort 6
n=8 Participants
HVs received single dose of RO7020531, 100 mg, orally on Day 1.
|
Part 1 SAD: Cohort 7
n=8 Participants
HVs received single dose of RO7020531, 140 mg, orally on Day 1.
|
Part 1 SAD: Cohort 8
HVs received single dose of RO7020531, 170 mg, orally on Day 1.
|
Part 1 MAD: Cohort 2
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 2
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Total Amount of RO7020531, RO7011785, RO7018822 and RO7033805 in Urine: SAD
RO7011785
|
1.70 mg
Standard Deviation 0.274
|
5.04 mg
Standard Deviation 1.23
|
11.0 mg
Standard Deviation 1.92
|
18.2 mg
Standard Deviation 8.96
|
25.5 mg
Standard Deviation 7.81
|
48.1 mg
Standard Deviation 17.7
|
68.6 mg
Standard Deviation 16.7
|
83.5 mg
Standard Deviation 17.4
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Total Amount of RO7020531, RO7011785, RO7018822 and RO7033805 in Urine: SAD
RO7020531
|
0.00 mg
Standard Deviation 0.00
|
0.00 mg
Standard Deviation 0.00
|
0.00 mg
Standard Deviation 0.00
|
0.00 mg
Standard Deviation 0.00
|
0.00 mg
Standard Deviation 0.00
|
0.00 mg
Standard Deviation 0.00
|
0.00 mg
Standard Deviation 0.00
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Total Amount of RO7020531, RO7011785, RO7018822 and RO7033805 in Urine: SAD
RO7018822
|
0.0137 mg
Standard Deviation 0.0167
|
0.0754 mg
Standard Deviation 0.0274
|
0.188 mg
Standard Deviation 0.0399
|
0.271 mg
Standard Deviation 0.171
|
0.372 mg
Standard Deviation 0.145
|
0.728 mg
Standard Deviation 0.337
|
1.10 mg
Standard Deviation 0.417
|
1.87 mg
Standard Deviation 1.00
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Total Amount of RO7020531, RO7011785, RO7018822 and RO7033805 in Urine: SAD
RO7033805
|
0.00 mg
Standard Deviation 0.00
|
0.00 mg
Standard Deviation 0.00
|
0.00 mg
Standard Deviation 0.00
|
0.00 mg
Standard Deviation 0.00
|
0.00 mg
Standard Deviation 0.00
|
0.00 mg
Standard Deviation 0.00
|
0.00 mg
Standard Deviation 0.00
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: SAD: Predose, 2, 6, 12 and 24 hrs Postdose; MAD: Predose, 2, 6, 12, and 24 hrs Postdose on Day 1; Predose, 2, 6 and 24 hrs Postdose on Days 3, 5, 7, 13 and 20Population: Pharmacodynamic population included all HVs who had received at least 1 dose of the study drug and with PD data available.
Mean concentrations of IFN-alpha for SAD were calculated following single-dose and for MAD it was calculated following multiple doses. The standard deviation (SD) presented is actually the log transformed geometric standard deviation.
Outcome measures
| Measure |
Part 1 Cohorts 1-8 SAD: Placebo
n=16 Participants
In SAD Cohorts 1-8, sixteen HVs, two in each cohort, received a single dose of RO7020531 matching placebo, on Day 1.
|
Part 1 SAD: Cohort 1
n=8 Participants
HVs received single dose of RO7020531, 3 mg, orally on Day 1.
|
Part 1 SAD: Cohort 2
n=8 Participants
HVs received single dose of RO7020531, 10 mg, orally on Day 1.
|
Part 1 SAD: Cohort 3
n=8 Participants
HVs received single dose of RO7020531, 20 mg, orally on Day 1.
|
Part 1 SAD: Cohort 4
n=8 Participants
HVs received single dose of RO7020531, 40 mg, orally on Day 1.
|
Part 1 SAD: Cohort 5
n=8 Participants
HVs received single dose of RO7020531, 60 mg, orally on Day 1.
|
Part 1 SAD: Cohort 6
n=8 Participants
HVs received single dose of RO7020531, 100 mg, orally on Day 1.
|
Part 1 SAD: Cohort 7
n=8 Participants
HVs received single dose of RO7020531, 140 mg, orally on Day 1.
|
Part 1 SAD: Cohort 8
n=8 Participants
HVs received single dose of RO7020531, 170 mg, orally on Day 1.
|
Part 1 MAD: Cohort 2
n=6 Participants
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
n=8 Participants
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 2
n=8 Participants
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
n=8 Participants
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1:Mean Concentration of Interferon Alpha (IFN-alpha): SAD and MAD
|
0.0484 picogram per milliliter (pg/mL)
Standard Deviation 1.3166
|
0.0475 picogram per milliliter (pg/mL)
Standard Deviation 1.4288
|
0.0438 picogram per milliliter (pg/mL)
Standard Deviation 1.1316
|
0.0447 picogram per milliliter (pg/mL)
Standard Deviation 1.1166
|
0.0436 picogram per milliliter (pg/mL)
Standard Deviation 1.0600
|
0.0494 picogram per milliliter (pg/mL)
Standard Deviation 1.5718
|
0.0533 picogram per milliliter (pg/mL)
Standard Deviation 1.5205
|
0.1385 picogram per milliliter (pg/mL)
Standard Deviation 3.8417
|
0.1358 picogram per milliliter (pg/mL)
Standard Deviation 3.8126
|
0.0530 picogram per milliliter (pg/mL)
Standard Deviation 1.0135
|
0.0761 picogram per milliliter (pg/mL)
Standard Deviation 1.9769
|
0.1148 picogram per milliliter (pg/mL)
Standard Deviation 3.1080
|
0.3349 picogram per milliliter (pg/mL)
Standard Deviation 5.5985
|
SECONDARY outcome
Timeframe: Predose, 6, 8 and 24 hrs Postdose on Day 1; Predose, 4-6, 24 hrs Postdose on Days 3, 7 and 21; Predose, 6, 24 hrs Postdose on Day 41Population: Pharmacodynamic population included all participants who had received at least 1 dose of the study drug and with PD data available.
Mean concentrations of IFN-alpha for Part 2 were calculated following multiple doses. The SD presented is actually the log transformed geometric standard deviation.
Outcome measures
| Measure |
Part 1 Cohorts 1-8 SAD: Placebo
n=6 Participants
In SAD Cohorts 1-8, sixteen HVs, two in each cohort, received a single dose of RO7020531 matching placebo, on Day 1.
|
Part 1 SAD: Cohort 1
n=16 Participants
HVs received single dose of RO7020531, 3 mg, orally on Day 1.
|
Part 1 SAD: Cohort 2
n=8 Participants
HVs received single dose of RO7020531, 10 mg, orally on Day 1.
|
Part 1 SAD: Cohort 3
n=5 Participants
HVs received single dose of RO7020531, 20 mg, orally on Day 1.
|
Part 1 SAD: Cohort 4
n=15 Participants
HVs received single dose of RO7020531, 40 mg, orally on Day 1.
|
Part 1 SAD: Cohort 5
HVs received single dose of RO7020531, 60 mg, orally on Day 1.
|
Part 1 SAD: Cohort 6
HVs received single dose of RO7020531, 100 mg, orally on Day 1.
|
Part 1 SAD: Cohort 7
HVs received single dose of RO7020531, 140 mg, orally on Day 1.
|
Part 1 SAD: Cohort 8
HVs received single dose of RO7020531, 170 mg, orally on Day 1.
|
Part 1 MAD: Cohort 2
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 2
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Mean Concentration of IFN-alpha
|
0.0533 pg/mL
Standard Deviation 1.0668
|
0.3801 pg/mL
Standard Deviation 9.1442
|
0.2831 pg/mL
Standard Deviation 9.0521
|
0.0574 pg/mL
Standard Deviation 1.2737
|
0.3161 pg/mL
Standard Deviation 8.0853
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: SAD: Predose, 2, 6, 12, 24, 48 (only Neopterin) and 96 hrs (only Neopterin) Postdose; MAD: Predose, 2, 6, 12, and 24 hrs Postdose on Day 1; Predose, 2, 6 and 24 hrs Postdose on Days 3, 5, 7, 13 and 20Population: Pharmacodynamic population included all HVs who had received at least 1 dose of the study drug and with PD data available.
Cytokines markers include Chemokine (C-X-C Motif) Ligand 10 (IP-10), Interleukin 6 (IL-6), Interleukin 10 (IL-10), Interleukin 12 p40 (IL-12 p40), Neopterin, Tumor Necrosis Factor-Alpha (TNF-alpha). The SD presented is actually the log transformed geometric standard deviation.
Outcome measures
| Measure |
Part 1 Cohorts 1-8 SAD: Placebo
n=16 Participants
In SAD Cohorts 1-8, sixteen HVs, two in each cohort, received a single dose of RO7020531 matching placebo, on Day 1.
|
Part 1 SAD: Cohort 1
n=8 Participants
HVs received single dose of RO7020531, 3 mg, orally on Day 1.
|
Part 1 SAD: Cohort 2
n=8 Participants
HVs received single dose of RO7020531, 10 mg, orally on Day 1.
|
Part 1 SAD: Cohort 3
n=8 Participants
HVs received single dose of RO7020531, 20 mg, orally on Day 1.
|
Part 1 SAD: Cohort 4
n=8 Participants
HVs received single dose of RO7020531, 40 mg, orally on Day 1.
|
Part 1 SAD: Cohort 5
n=8 Participants
HVs received single dose of RO7020531, 60 mg, orally on Day 1.
|
Part 1 SAD: Cohort 6
n=8 Participants
HVs received single dose of RO7020531, 100 mg, orally on Day 1.
|
Part 1 SAD: Cohort 7
n=8 Participants
HVs received single dose of RO7020531, 140 mg, orally on Day 1.
|
Part 1 SAD: Cohort 8
n=8 Participants
HVs received single dose of RO7020531, 170 mg, orally on Day 1.
|
Part 1 MAD: Cohort 2
n=6 Participants
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
n=8 Participants
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 2
n=8 Participants
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
n=8 Participants
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD
Neopterin
|
0.9861 Fold change
Standard Deviation 1.1833
|
1.0561 Fold change
Standard Deviation 1.3678
|
1.0175 Fold change
Standard Deviation 1.2665
|
0.9878 Fold change
Standard Deviation 1.2300
|
0.9975 Fold change
Standard Deviation 1.1503
|
0.9896 Fold change
Standard Deviation 1.2475
|
0.9738 Fold change
Standard Deviation 1.1791
|
1.0688 Fold change
Standard Deviation 1.3926
|
1.1257 Fold change
Standard Deviation 1.4298
|
0.9331 Fold change
Standard Deviation 1.1446
|
1.5842 Fold change
Standard Deviation 1.3637
|
1.1228 Fold change
Standard Deviation 1.5260
|
1.5453 Fold change
Standard Deviation 1.5431
|
|
Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD
IP-10
|
0.9067 Fold change
Standard Deviation 1.3101
|
0.8751 Fold change
Standard Deviation 1.4713
|
0.9112 Fold change
Standard Deviation 1.3624
|
0.9250 Fold change
Standard Deviation 1.2966
|
0.9754 Fold change
Standard Deviation 1.2328
|
0.9267 Fold change
Standard Deviation 1.2754
|
1.0390 Fold change
Standard Deviation 1.2198
|
1.6532 Fold change
Standard Deviation 2.0266
|
1.2909 Fold change
Standard Deviation 1.8003
|
1.0256 Fold change
Standard Deviation 1.4853
|
1.2010 Fold change
Standard Deviation 1.4186
|
1.2076 Fold change
Standard Deviation 1.7543
|
1.7327 Fold change
Standard Deviation 2.3938
|
|
Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD
IL-12 p40
|
1.0276 Fold change
Standard Deviation 1.2232
|
0.9414 Fold change
Standard Deviation 1.3431
|
1.0419 Fold change
Standard Deviation 1.2198
|
0.9706 Fold change
Standard Deviation 1.0957
|
1.0000 Fold change
Standard Deviation 1.0000
|
1.0012 Fold change
Standard Deviation 1.0156
|
1.0000 Fold change
Standard Deviation 1.0000
|
1.0025 Fold change
Standard Deviation 1.1817
|
1.0009 Fold change
Standard Deviation 1.0049
|
0.6782 Fold change
Standard Deviation 1.7025
|
0.8672 Fold change
Standard Deviation 1.3474
|
0.9588 Fold change
Standard Deviation 1.3470
|
0.9002 Fold change
Standard Deviation 1.3373
|
|
Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD
IL-10
|
0.9692 Fold change
Standard Deviation 1.5013
|
0.7042 Fold change
Standard Deviation 2.0970
|
1.0568 Fold change
Standard Deviation 1.5139
|
0.9622 Fold change
Standard Deviation 1.3461
|
0.9483 Fold change
Standard Deviation 1.4871
|
0.7451 Fold change
Standard Deviation 2.3095
|
1.0047 Fold change
Standard Deviation 1.3322
|
1.1900 Fold change
Standard Deviation 1.6328
|
1.1926 Fold change
Standard Deviation 1.4208
|
0.6841 Fold change
Standard Deviation 3.4286
|
1.0961 Fold change
Standard Deviation 1.4560
|
0.8834 Fold change
Standard Deviation 1.5662
|
1.1232 Fold change
Standard Deviation 1.5901
|
|
Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD
IL-6
|
1.4493 Fold change
Standard Deviation 2.4225
|
1.9626 Fold change
Standard Deviation 2.9840
|
1.2293 Fold change
Standard Deviation 1.9209
|
1.2464 Fold change
Standard Deviation 2.5694
|
1.2857 Fold change
Standard Deviation 1.8437
|
0.9486 Fold change
Standard Deviation 1.9942
|
1.3207 Fold change
Standard Deviation 2.0960
|
1.4167 Fold change
Standard Deviation 2.3111
|
1.6928 Fold change
Standard Deviation 2.1981
|
1.8290 Fold change
Standard Deviation 2.8323
|
1.3521 Fold change
Standard Deviation 2.2473
|
1.9065 Fold change
Standard Deviation 2.2325
|
1.1306 Fold change
Standard Deviation 2.3792
|
|
Part 1: Mean Fold Change From Baseline in Cytokine Markers: SAD and MAD
TNF-alpha
|
1.0875 Fold change
Standard Deviation 1.8701
|
1.0374 Fold change
Standard Deviation 1.7561
|
0.9435 Fold change
Standard Deviation 1.4360
|
0.8698 Fold change
Standard Deviation 2.1721
|
1.0781 Fold change
Standard Deviation 1.4358
|
0.8825 Fold change
Standard Deviation 1.7991
|
0.9249 Fold change
Standard Deviation 1.6530
|
0.9663 Fold change
Standard Deviation 1.7846
|
1.1756 Fold change
Standard Deviation 1.5505
|
1.0830 Fold change
Standard Deviation 1.6154
|
1.2136 Fold change
Standard Deviation 1.5828
|
0.9887 Fold change
Standard Deviation 1.5106
|
0.8985 Fold change
Standard Deviation 1.6625
|
SECONDARY outcome
Timeframe: Predose, 6, 8 and 24 hrs Postdose on Day 1; Predose, 4-6, 24 hrs Postdose on Days 3, 7 and 21; Predose, 6, 24 hrs Postdose on Day 41Population: Pharmacodynamic population included all participants who had received at least 1 dose of the study drug and with PD data available.
Cytokines markers included IP- 10, IL- 6, IL-1 10, IL-12 p40, Neopterin and TNF -alpha. The SD presented is actually the log transformed geometric standard deviation.
Outcome measures
| Measure |
Part 1 Cohorts 1-8 SAD: Placebo
n=6 Participants
In SAD Cohorts 1-8, sixteen HVs, two in each cohort, received a single dose of RO7020531 matching placebo, on Day 1.
|
Part 1 SAD: Cohort 1
n=16 Participants
HVs received single dose of RO7020531, 3 mg, orally on Day 1.
|
Part 1 SAD: Cohort 2
n=8 Participants
HVs received single dose of RO7020531, 10 mg, orally on Day 1.
|
Part 1 SAD: Cohort 3
n=5 Participants
HVs received single dose of RO7020531, 20 mg, orally on Day 1.
|
Part 1 SAD: Cohort 4
n=15 Participants
HVs received single dose of RO7020531, 40 mg, orally on Day 1.
|
Part 1 SAD: Cohort 5
HVs received single dose of RO7020531, 60 mg, orally on Day 1.
|
Part 1 SAD: Cohort 6
HVs received single dose of RO7020531, 100 mg, orally on Day 1.
|
Part 1 SAD: Cohort 7
HVs received single dose of RO7020531, 140 mg, orally on Day 1.
|
Part 1 SAD: Cohort 8
HVs received single dose of RO7020531, 170 mg, orally on Day 1.
|
Part 1 MAD: Cohort 2
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 2
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Mean Fold Change From Baseline in Cytokine Markers
Neopterin
|
1.0473 Fold change
Standard Deviation 1.2426
|
1.5596 Fold change
Standard Deviation 1.7824
|
1.7935 Fold change
Standard Deviation 1.9267
|
1.0591 Fold change
Standard Deviation 1.5154
|
1.4676 Fold change
Standard Deviation 1.7203
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Mean Fold Change From Baseline in Cytokine Markers
IP-10
|
0.9007 Fold change
Standard Deviation 1.3368
|
2.2323 Fold change
Standard Deviation 2.6810
|
2.1018 Fold change
Standard Deviation 2.9560
|
0.8939 Fold change
Standard Deviation 1.3557
|
1.8598 Fold change
Standard Deviation 2.6359
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Mean Fold Change From Baseline in Cytokine Markers
IL-12 p40
|
1.0000 Fold change
Standard Deviation 1.0000
|
1.0109 Fold change
Standard Deviation 1.1763
|
0.9624 Fold change
Standard Deviation 1.1261
|
1.0000 Fold change
Standard Deviation 1.0000
|
0.9740 Fold change
Standard Deviation 1.1886
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Mean Fold Change From Baseline in Cytokine Markers
IL-10
|
1.0428 Fold change
Standard Deviation 1.3767
|
1.2587 Fold change
Standard Deviation 1.5415
|
1.3441 Fold change
Standard Deviation 1.9726
|
0.8232 Fold change
Standard Deviation 1.6060
|
1.2540 Fold change
Standard Deviation 1.8818
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Mean Fold Change From Baseline in Cytokine Markers
IL-6
|
1.0172 Fold change
Standard Deviation 1.1251
|
1.0909 Fold change
Standard Deviation 1.4962
|
1.4235 Fold change
Standard Deviation 2.1969
|
0.8127 Fold change
Standard Deviation 1.4478
|
1.1596 Fold change
Standard Deviation 1.6084
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Mean Fold Change From Baseline in Cytokine Markers
TNF-alpha
|
0.9848 Fold change
Standard Deviation 1.4186
|
1.2674 Fold change
Standard Deviation 1.6169
|
1.0527 Fold change
Standard Deviation 1.6605
|
1.0415 Fold change
Standard Deviation 1.3014
|
1.0418 Fold change
Standard Deviation 1.5470
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: SAD: Predose, 2, 6, 12 and 24 Postdose; MAD: Predose, 2, 6, 12, and 24 hrs Postdose on Day 1; Predose, 2, 6 and 24 hrs Postdose on Days 3, 5, 7, 13 and 20Population: Pharmacodynamic population included all HVs who had received at least 1 dose of the study drug and with PD data available.
Markers of transcriptional responses includes messenger ribonucleic acid interferon-stimulated gene 15(mRNA ISG15), messenger RNA oligoadenylate synthetase 1 (mRNA OAS1), messenger RNA myxovirus resistance 1 gene (mRNA MX-1), messenger RNA Toll-like receptor (mRNA TLR7). The SD presented is actually the log transformed geometric standard deviation.
Outcome measures
| Measure |
Part 1 Cohorts 1-8 SAD: Placebo
n=16 Participants
In SAD Cohorts 1-8, sixteen HVs, two in each cohort, received a single dose of RO7020531 matching placebo, on Day 1.
|
Part 1 SAD: Cohort 1
n=8 Participants
HVs received single dose of RO7020531, 3 mg, orally on Day 1.
|
Part 1 SAD: Cohort 2
n=8 Participants
HVs received single dose of RO7020531, 10 mg, orally on Day 1.
|
Part 1 SAD: Cohort 3
n=8 Participants
HVs received single dose of RO7020531, 20 mg, orally on Day 1.
|
Part 1 SAD: Cohort 4
n=8 Participants
HVs received single dose of RO7020531, 40 mg, orally on Day 1.
|
Part 1 SAD: Cohort 5
n=8 Participants
HVs received single dose of RO7020531, 60 mg, orally on Day 1.
|
Part 1 SAD: Cohort 6
n=8 Participants
HVs received single dose of RO7020531, 100 mg, orally on Day 1.
|
Part 1 SAD: Cohort 7
n=8 Participants
HVs received single dose of RO7020531, 140 mg, orally on Day 1.
|
Part 1 SAD: Cohort 8
n=8 Participants
HVs received single dose of RO7020531, 170 mg, orally on Day 1.
|
Part 1 MAD: Cohort 2
n=6 Participants
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
n=8 Participants
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 2
n=8 Participants
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
n=8 Participants
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1:Mean Fold Change From Baseline in Markers of Transcriptional Responses: SAD and MAD
mRNA ISG15
|
0.9709 Fold change
Standard Deviation 1.2752
|
1.1708 Fold change
Standard Deviation 1.9326
|
1.0525 Fold change
Standard Deviation 1.3985
|
0.9386 Fold change
Standard Deviation 1.5924
|
1.0799 Fold change
Standard Deviation 1.3980
|
1.0190 Fold change
Standard Deviation 1.6295
|
1.6951 Fold change
Standard Deviation 2.5735
|
3.0359 Fold change
Standard Deviation 4.0456
|
3.1083 Fold change
Standard Deviation 3.9014
|
1.1703 Fold change
Standard Deviation 1.6841
|
1.9408 Fold change
Standard Deviation 2.6372
|
2.3632 Fold change
Standard Deviation 2.8453
|
4.8748 Fold change
Standard Deviation 4.1091
|
|
Part 1:Mean Fold Change From Baseline in Markers of Transcriptional Responses: SAD and MAD
mRNA OAS1
|
1.0251 Fold change
Standard Deviation 1.2295
|
1.0414 Fold change
Standard Deviation 1.4571
|
1.0338 Fold change
Standard Deviation 1.2876
|
0.9666 Fold change
Standard Deviation 1.4060
|
0.8584 Fold change
Standard Deviation 1.7499
|
1.0680 Fold change
Standard Deviation 1.4851
|
1.4093 Fold change
Standard Deviation 1.7808
|
2.3437 Fold change
Standard Deviation 2.5254
|
2.2308 Fold change
Standard Deviation 2.4993
|
1.0651 Fold change
Standard Deviation 1.5253
|
1.8186 Fold change
Standard Deviation 2.3871
|
2.1467 Fold change
Standard Deviation 2.2610
|
3.2312 Fold change
Standard Deviation 3.0239
|
|
Part 1:Mean Fold Change From Baseline in Markers of Transcriptional Responses: SAD and MAD
mRNA Mx-1
|
1.0179 Fold change
Standard Deviation 1.3078
|
0.9750 Fold change
Standard Deviation 1.5209
|
1.0166 Fold change
Standard Deviation 1.4143
|
0.9045 Fold change
Standard Deviation 1.4844
|
0.8811 Fold change
Standard Deviation 1.5884
|
1.0837 Fold change
Standard Deviation 1.6314
|
1.5271 Fold change
Standard Deviation 2.3070
|
2.8672 Fold change
Standard Deviation 3.5170
|
2.6646 Fold change
Standard Deviation 3.0944
|
0.9813 Fold change
Standard Deviation 1.5661
|
2.3613 Fold change
Standard Deviation 2.8339
|
2.0847 Fold change
Standard Deviation 2.8118
|
3.2388 Fold change
Standard Deviation 3.9277
|
|
Part 1:Mean Fold Change From Baseline in Markers of Transcriptional Responses: SAD and MAD
mRNA TLR7
|
1.0698 Fold change
Standard Deviation 1.3124
|
1.1518 Fold change
Standard Deviation 1.3697
|
1.0401 Fold change
Standard Deviation 1.2667
|
1.0658 Fold change
Standard Deviation 1.2237
|
1.0965 Fold change
Standard Deviation 1.3698
|
1.1289 Fold change
Standard Deviation 1.2710
|
1.2120 Fold change
Standard Deviation 1.3328
|
1.5925 Fold change
Standard Deviation 1.6473
|
1.5596 Fold change
Standard Deviation 2.1403
|
1.2315 Fold change
Standard Deviation 1.6428
|
1.2089 Fold change
Standard Deviation 1.6716
|
1.2626 Fold change
Standard Deviation 1.5696
|
1.6081 Fold change
Standard Deviation 1.8082
|
SECONDARY outcome
Timeframe: Predose, 6, 8, 24 hrs postdose on Day 1; Predose, 4-6, 24 hrs postdose on Days 3, 7, 21; Predose, 6, 24 hrs postdose on Day 41Population: Pharmacodynamic population included all participants who had received at least 1 dose of the study drug and with PD data available.
Transcriptional markers include mRNA ISG15, mRNA OAS1, mRNA MX-1, mRNA TLR7. The SD presented is actually the log transformed geometric standard deviation.
Outcome measures
| Measure |
Part 1 Cohorts 1-8 SAD: Placebo
n=6 Participants
In SAD Cohorts 1-8, sixteen HVs, two in each cohort, received a single dose of RO7020531 matching placebo, on Day 1.
|
Part 1 SAD: Cohort 1
n=16 Participants
HVs received single dose of RO7020531, 3 mg, orally on Day 1.
|
Part 1 SAD: Cohort 2
n=8 Participants
HVs received single dose of RO7020531, 10 mg, orally on Day 1.
|
Part 1 SAD: Cohort 3
n=5 Participants
HVs received single dose of RO7020531, 20 mg, orally on Day 1.
|
Part 1 SAD: Cohort 4
n=15 Participants
HVs received single dose of RO7020531, 40 mg, orally on Day 1.
|
Part 1 SAD: Cohort 5
HVs received single dose of RO7020531, 60 mg, orally on Day 1.
|
Part 1 SAD: Cohort 6
HVs received single dose of RO7020531, 100 mg, orally on Day 1.
|
Part 1 SAD: Cohort 7
HVs received single dose of RO7020531, 140 mg, orally on Day 1.
|
Part 1 SAD: Cohort 8
HVs received single dose of RO7020531, 170 mg, orally on Day 1.
|
Part 1 MAD: Cohort 2
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 2
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Mean Fold Change From Baseline in Markers of Transcriptional Responses
mRNA ISG15
|
1.0745 Fold change
Standard Deviation 1.6135
|
4.2007 Fold change
Standard Deviation 3.9059
|
6.8997 Fold change
Standard Deviation 4.1313
|
0.8661 Fold change
Standard Deviation 1.5914
|
3.9424 Fold change
Standard Deviation 3.3660
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Mean Fold Change From Baseline in Markers of Transcriptional Responses
mRNA OAS1
|
0.9617 Fold change
Standard Deviation 1.2926
|
3.1021 Fold change
Standard Deviation 2.6766
|
4.0466 Fold change
Standard Deviation 2.7318
|
0.7973 Fold change
Standard Deviation 1.4425
|
3.0355 Fold change
Standard Deviation 2.4692
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Mean Fold Change From Baseline in Markers of Transcriptional Responses
mRNA Mx-1
|
0.9140 Fold change
Standard Deviation 1.4847
|
3.1760 Fold change
Standard Deviation 3.2606
|
5.0962 Fold change
Standard Deviation 3.3744
|
0.8296 Fold change
Standard Deviation 1.3309
|
3.4811 Fold change
Standard Deviation 2.9921
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Mean Fold Change From Baseline in Markers of Transcriptional Responses
mRNA TLR7
|
1.0848 Fold change
Standard Deviation 1.4306
|
1.5280 Fold change
Standard Deviation 1.7527
|
1.5745 Fold change
Standard Deviation 1.7411
|
1.0240 Fold change
Standard Deviation 1.3620
|
1.3211 Fold change
Standard Deviation 1.9422
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: SAD: Predose, 0.5, 1, 2, 4, 6, 12, 24 and 48 hrs Post dose on Day 1; MAD: Predose, 0.5, 1,2,4 and 12 hrs Postdose on Day 1 and 13; Predose, 2 and 6 hrs Postdose on Day 3, Predose, 6 and 24 hrs Postdose on Day , 7, 9, and 11Population: Data was not collected for this Outcome Measure due to change in planned analyses. This analysis will be performed after CSR finalization, as its results will only be required before executing a Phase 3 study with RO7020531.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose and 2-4 hours post-dose on Day 1, Day 21 and Day 41Population: The PK analysis population included all participants randomised and adherent to the protocol. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants available at the specific timepoints.
Adefovir was not administered to any participants in the study. Hence, no data could be collected for plasma concentration of adefovir. As participants in each cohort received different NUCs the data for Cohorts 1, 2 and 3 have been reported separately.
Outcome measures
| Measure |
Part 1 Cohorts 1-8 SAD: Placebo
n=6 Participants
In SAD Cohorts 1-8, sixteen HVs, two in each cohort, received a single dose of RO7020531 matching placebo, on Day 1.
|
Part 1 SAD: Cohort 1
n=5 Participants
HVs received single dose of RO7020531, 3 mg, orally on Day 1.
|
Part 1 SAD: Cohort 2
n=5 Participants
HVs received single dose of RO7020531, 10 mg, orally on Day 1.
|
Part 1 SAD: Cohort 3
HVs received single dose of RO7020531, 20 mg, orally on Day 1.
|
Part 1 SAD: Cohort 4
HVs received single dose of RO7020531, 40 mg, orally on Day 1.
|
Part 1 SAD: Cohort 5
HVs received single dose of RO7020531, 60 mg, orally on Day 1.
|
Part 1 SAD: Cohort 6
HVs received single dose of RO7020531, 100 mg, orally on Day 1.
|
Part 1 SAD: Cohort 7
HVs received single dose of RO7020531, 140 mg, orally on Day 1.
|
Part 1 SAD: Cohort 8
HVs received single dose of RO7020531, 170 mg, orally on Day 1.
|
Part 1 MAD: Cohort 2
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 2
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine
Entecavir - Day 21: Predose
|
0.494 ng/mL
Standard Deviation 0.07
|
0.365 ng/mL
Standard Deviation 0.09
|
0.810 ng/mL
Standard Deviation 0.92
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine
Entecavir - Day 21: 2-4 hours Post Dose
|
1.543 ng/mL
Standard Deviation 0.76
|
1.568 ng/mL
Standard Deviation 0.80
|
0.935 ng/mL
Standard Deviation 0.20
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine
Entecavir - Day 41: Predose
|
0.406 ng/mL
Standard Deviation 0.10
|
0.308 ng/mL
Standard Deviation 0.08
|
0.887 ng/mL
Standard Deviation 0.89
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine
Entecavir - Day 41: 2-4 hours Post Dose
|
1.373 ng/mL
Standard Deviation 0.66
|
1.267 ng/mL
Standard Deviation 0.50
|
1.427 ng/mL
Standard Deviation 0.69
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine
Tenofovir - Day 1: Predose
|
54.93 ng/mL
Standard Deviation 32.7
|
60.00 ng/mL
Standard Deviation 26.5
|
71.12 ng/mL
Standard Deviation 35.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine
Entecavir - Day 1: Predose
|
0.467 ng/mL
Standard Deviation 0.13
|
0.420 ng/mL
Standard Deviation 0.10
|
0.590 ng/mL
Standard Deviation 0.62
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine
Tenofovir - Day 1: 2-4 hours Post Dose
|
155.1 ng/mL
Standard Deviation 106
|
214.2 ng/mL
Standard Deviation 64.0
|
245.0 ng/mL
Standard Deviation 49.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine
Tenofovir - Day 21: Predose
|
63.90 ng/mL
Standard Deviation 29.5
|
58.40 ng/mL
Standard Deviation 21.4
|
57.02 ng/mL
Standard Deviation 28.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine
Tenofovir - Day 21: 2-4 hours Post Dose
|
206.6 ng/mL
Standard Deviation 81.4
|
273.0 ng/mL
Standard Deviation 177
|
222.2 ng/mL
Standard Deviation 70.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine
Tenofovir - Day 41: Predose
|
66.82 ng/mL
Standard Deviation 34.0
|
64.06 ng/mL
Standard Deviation 32.7
|
56.56 ng/mL
Standard Deviation 26.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine
Tenofovir - Day 41: 2-4 hours Post Dose
|
250.9 ng/mL
Standard Deviation 108
|
250.4 ng/mL
Standard Deviation 112
|
188.4 ng/mL
Standard Deviation 58.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine
Tenofovir Alafenamide - Day 1: 2-4 hours Post Dose
|
—
|
0.058 ng/mL
Standard Deviation 0.058
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine
Entecavir - Day 1: 2-4 hours Post Dose
|
1.974 ng/mL
Standard Deviation 1.08
|
1.455 ng/mL
Standard Deviation 0.53
|
1.019 ng/mL
Standard Deviation 0.60
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine
Telbivudine - Day 1: Predose
|
—
|
602.0 ng/mL
Standard Deviation 602.0
|
330.0 ng/mL
Standard Deviation 330.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine
Telbivudine - Day 1: 2-4 hours Post Dose
|
—
|
4760 ng/mL
Standard Deviation 4760
|
2820 ng/mL
Standard Deviation 2820
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine
Telbivudine - Day 21: Predose
|
—
|
1030 ng/mL
Standard Deviation 1030
|
314.0 ng/mL
Standard Deviation 314.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine
Telbivudine - Day 21: 2-4 hours Post Dose
|
—
|
2030 ng/mL
Standard Deviation 2030
|
1790 ng/mL
Standard Deviation 1790
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine
Telbivudine - Day 41: Predose
|
—
|
935.0 ng/mL
Standard Deviation 935.0
|
260.0 ng/mL
Standard Deviation 260.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Plasma Concentrations of Tenofovir, Tenofovir Alafenamide, Entecavir, Adefovir and Telbivudine
Telbivudine - Day 41: 2-4 hours Post Dose
|
—
|
2850 ng/mL
Standard Deviation 2850
|
2450 ng/mL
Standard Deviation 2450
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Part 1 Cohorts 1-8 SAD: Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 1 SAD: Cohort 1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1 SAD: Cohort 2
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 1 SAD: Cohort 3
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1 SAD: Cohort 4
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1 SAD: Cohort 5
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1 SAD: Cohort 6
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1 SAD: Cohort 7
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1 SAD: Cohort 8
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1 Cohorts 1-3, MAD: Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 1 MAD: Cohort 1
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part 1 MAD: Cohort 2
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Part 1 MAD: Cohort 3
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Part 2 Cohorts 1-3: Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 2: Cohort 1 and 2
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Part 2: Cohort 3
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part 2 Cohort 4: Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 2: Cohort 4
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part 1 Cohorts 1-8 SAD: Placebo
n=16 participants at risk
In SAD Cohorts 1-8, sixteen HVs, two in each cohort, received a single dose of RO7020531 matching placebo, on Day 1.
|
Part 1 SAD: Cohort 1
n=8 participants at risk
HVs received single dose of RO7020531, 3 mg, orally on Day 1.
|
Part 1 SAD: Cohort 2
n=8 participants at risk
HVs received single dose of RO7020531, 10 mg, orally on Day 1.
|
Part 1 SAD: Cohort 3
n=8 participants at risk
HVs received single dose of RO7020531, 20 mg, orally on Day 1.
|
Part 1 SAD: Cohort 4
n=8 participants at risk
HVs received single dose of RO7020531, 40 mg, orally on Day 1.
|
Part 1 SAD: Cohort 5
n=8 participants at risk
HVs received single dose of RO7020531, 60 mg, orally on Day 1.
|
Part 1 SAD: Cohort 6
n=8 participants at risk
HVs received single dose of RO7020531, 100 mg, orally on Day 1.
|
Part 1 SAD: Cohort 7
n=8 participants at risk
HVs received single dose of RO7020531, 140 mg, orally on Day 1.
|
Part 1 SAD: Cohort 8
n=8 participants at risk
HVs received single dose of RO7020531, 170 mg, orally on Day 1.
|
Part 1 Cohorts 1-3, MAD: Placebo
n=6 participants at risk
In MAD Cohorts 1,2, and 3, six HVs, two in each cohort, received RO7020531 matching placebo orally on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 1
n=8 participants at risk
HVs received RO7020531, 100 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 2
n=8 participants at risk
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
n=8 participants at risk
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
Part 2 Cohorts 1-3: Placebo
n=6 participants at risk
In Cohorts 1,2, and 3, six participants, two in each cohort, Participants received RO7020531 matching placebo, along with NUC treatment, orally, on Day 1 and QOD for 41 days.
|
Part 2: Cohort 1 and 2
n=16 participants at risk
Sixteen participants received RO7020531, 150 mg, along with NUC treatment, orally, on Day 1 and QOD for 41 days. Cohorts 1 and 2 were both 150 mg cohorts and was presented as a single dose group.
|
Part 2: Cohort 3
n=8 participants at risk
Participants received RO7020531, 170 mg, along with NUC treatment, orally, on Day 1 and QOD for 41 days.
|
Part 2 Cohort 4: Placebo
n=5 participants at risk
Treatment naive participants received RO7020531 matching placebo, orally, on Day 1 and QOD for 41 days.
|
Part 2: Cohort 4
n=15 participants at risk
Treatment naive participants received RO7020531, 150 mg, orally, on Day 1 and QOD for 41 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Influenza like illness
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
6.7%
1/15 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
Other adverse events
| Measure |
Part 1 Cohorts 1-8 SAD: Placebo
n=16 participants at risk
In SAD Cohorts 1-8, sixteen HVs, two in each cohort, received a single dose of RO7020531 matching placebo, on Day 1.
|
Part 1 SAD: Cohort 1
n=8 participants at risk
HVs received single dose of RO7020531, 3 mg, orally on Day 1.
|
Part 1 SAD: Cohort 2
n=8 participants at risk
HVs received single dose of RO7020531, 10 mg, orally on Day 1.
|
Part 1 SAD: Cohort 3
n=8 participants at risk
HVs received single dose of RO7020531, 20 mg, orally on Day 1.
|
Part 1 SAD: Cohort 4
n=8 participants at risk
HVs received single dose of RO7020531, 40 mg, orally on Day 1.
|
Part 1 SAD: Cohort 5
n=8 participants at risk
HVs received single dose of RO7020531, 60 mg, orally on Day 1.
|
Part 1 SAD: Cohort 6
n=8 participants at risk
HVs received single dose of RO7020531, 100 mg, orally on Day 1.
|
Part 1 SAD: Cohort 7
n=8 participants at risk
HVs received single dose of RO7020531, 140 mg, orally on Day 1.
|
Part 1 SAD: Cohort 8
n=8 participants at risk
HVs received single dose of RO7020531, 170 mg, orally on Day 1.
|
Part 1 Cohorts 1-3, MAD: Placebo
n=6 participants at risk
In MAD Cohorts 1,2, and 3, six HVs, two in each cohort, received RO7020531 matching placebo orally on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 1
n=8 participants at risk
HVs received RO7020531, 100 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 2
n=8 participants at risk
HVs received RO7020531, 140 mg, orally, on Day 1 and QOD for 13 days.
|
Part 1 MAD: Cohort 3
n=8 participants at risk
HVs received RO7020531, 170 mg, orally, on Day 1 and QOD for 13 days.
|
Part 2 Cohorts 1-3: Placebo
n=6 participants at risk
In Cohorts 1,2, and 3, six participants, two in each cohort, Participants received RO7020531 matching placebo, along with NUC treatment, orally, on Day 1 and QOD for 41 days.
|
Part 2: Cohort 1 and 2
n=16 participants at risk
Sixteen participants received RO7020531, 150 mg, along with NUC treatment, orally, on Day 1 and QOD for 41 days. Cohorts 1 and 2 were both 150 mg cohorts and was presented as a single dose group.
|
Part 2: Cohort 3
n=8 participants at risk
Participants received RO7020531, 170 mg, along with NUC treatment, orally, on Day 1 and QOD for 41 days.
|
Part 2 Cohort 4: Placebo
n=5 participants at risk
Treatment naive participants received RO7020531 matching placebo, orally, on Day 1 and QOD for 41 days.
|
Part 2: Cohort 4
n=15 participants at risk
Treatment naive participants received RO7020531, 150 mg, orally, on Day 1 and QOD for 41 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Catheter site phlebitis
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
33.3%
2/6 • Number of events 3 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
General disorders
Chest pain
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
General disorders
Chills
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
6.2%
1/16 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
General disorders
Fatigue
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
25.0%
2/8 • Number of events 2 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
6.2%
1/16 • Number of events 2 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
13.3%
2/15 • Number of events 2 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
General disorders
Inflammation
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
General disorders
Influenza like illness
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
2/16 • Number of events 5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
26.7%
4/15 • Number of events 13 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
General disorders
Malaise
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
6.2%
1/16 • Number of events 2 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
6.7%
1/15 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
General disorders
Peripheral swelling
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
6.2%
1/16 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
General disorders
Polyp
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
6.2%
1/16 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
25.0%
2/8 • Number of events 2 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
25.0%
4/16 • Number of events 5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
6.7%
1/15 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
6.2%
1/16 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
6.7%
1/15 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
6.7%
1/15 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
6.2%
1/16 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
6.7%
1/15 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
6.2%
1/16 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
6.7%
1/15 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
6.2%
1/16 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Eye disorders
Chalazion
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
6.7%
1/15 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
6.2%
1/16 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
6.2%
1/16 • Number of events 4 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
25.0%
2/8 • Number of events 2 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
6.7%
1/15 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
33.3%
2/6 • Number of events 2 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
6.2%
1/16 • Number of events 2 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
6.2%
1/16 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Gastrointestinal disorders
Flatulence
|
6.2%
1/16 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 2 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
16.7%
1/6 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
37.5%
3/8 • Number of events 4 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
37.5%
3/8 • Number of events 3 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
6.2%
1/16 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
6.7%
1/15 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
6.7%
1/15 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
6.2%
1/16 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
6.7%
1/15 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
General disorders
Catheter site bruise
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
33.3%
2/6 • Number of events 2 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 2 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
37.5%
3/8 • Number of events 4 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
6.7%
1/15 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
General disorders
Catheter site erythema
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
16.7%
1/6 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
General disorders
Catheter site inflammation
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
25.0%
2/8 • Number of events 2 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
General disorders
Catheter site pain
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
37.5%
3/8 • Number of events 3 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
General disorders
Thirst
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
16.7%
1/6 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
25.0%
2/8 • Number of events 3 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
16.7%
1/6 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
20.0%
1/5 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
6.7%
1/15 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
20.0%
1/5 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Infections and infestations
Rhinitis
|
6.2%
1/16 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
16.7%
1/6 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
6.7%
1/15 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Infections and infestations
Viral infection
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
25.0%
2/8 • Number of events 2 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
20.0%
1/5 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
6.2%
1/16 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
13.3%
2/15 • Number of events 2 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
13.3%
2/15 • Number of events 2 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Investigations
Weight decreased
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
37.5%
3/8 • Number of events 3 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
6.2%
1/16 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
13.3%
2/15 • Number of events 2 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
6.2%
1/16 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 2 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
2/16 • Number of events 2 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.2%
1/16 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
16.7%
1/6 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
18.8%
3/16 • Number of events 18 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
20.0%
3/15 • Number of events 3 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
16.7%
1/6 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
16.7%
1/6 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
2/16 • Number of events 3 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
13.3%
2/15 • Number of events 3 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
6.2%
1/16 • Number of events 3 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
25.0%
2/8 • Number of events 2 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
16.7%
1/6 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
37.5%
3/8 • Number of events 4 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
37.5%
3/8 • Number of events 4 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
37.5%
3/8 • Number of events 3 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
16.7%
1/6 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
18.8%
3/16 • Number of events 7 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
50.0%
4/8 • Number of events 4 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
26.7%
4/15 • Number of events 4 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
6.2%
1/16 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
6.7%
1/15 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Nervous system disorders
Presyncope
|
6.2%
1/16 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Nervous system disorders
Tremor
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
6.7%
1/15 • Number of events 3 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Psychiatric disorders
Affect lability
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
6.2%
1/16 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Psychiatric disorders
Depressed mood
|
6.2%
1/16 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
6.2%
1/16 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Reproductive system and breast disorders
Premenstrual pain
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
6.2%
1/16 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
16.7%
1/6 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
6.2%
1/16 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
6.7%
1/15 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
6.7%
1/15 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
20.0%
1/5 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
6.2%
1/16 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
50.0%
3/6 • Number of events 7 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
20.0%
1/5 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
6.7%
1/15 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema ab igne
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
20.0%
1/5 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
16.7%
1/6 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
12.5%
1/8 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/15 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
6.7%
1/15 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/6 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/16 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/8 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
0.00%
0/5 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
6.7%
1/15 • Number of events 1 • From Randomization to End of Study (up to 4.5 years)
Safety analysis population included all HVs or participants who had received at least 1 dose of the study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER