Trial Outcomes & Findings for A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of RO7062931 in Healthy Chinese Volunteers. (NCT NCT03505190)
NCT ID: NCT03505190
Last Updated: 2020-08-03
Results Overview
Adverse events of special interest for this study include the following: * Cases of an elevated ALT or AST in combination with either an elevated bilirubin or clinical jaundice * Suspected transmission of an infectious agent by the study drug * Severe injection site reactions * Renal adverse events
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
41 participants
Primary outcome timeframe
Up to 16 weeks
Results posted on
2020-08-03
Participant Flow
Planned: Up to 50 healthy volunteers (HVs) across 5 cohorts of 10 HVs (8 active, 2 placebo) per dose-level. Actual: A total of 41 HVs were enrolled across 4 dose cohorts.
Participant milestones
| Measure |
RO7062931 0.3mg/kg
Participants will receive subcutaneously (SC) 0.3 milligram per kilogram (mg/kg) of RO7062931.
|
RO7062931 1.0mg/kg
Participants will receive subcutaneously (SC) 1.0 milligram per kilogram (mg/kg) of RO7062931.
|
RO7062931 2.0mg/kg
Participants will receive subcutaneously (SC) 2.0 milligram per kilogram (mg/kg) of RO7062931.
|
RO7062931 4.0mg/kg
Participants will receive subcutaneously (SC) 4.0 milligram per kilogram (mg/kg) of RO7062931.
|
Placebo
Participants will receive matching placebo.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
8
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
9
|
8
|
8
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of RO7062931 in Healthy Chinese Volunteers.
Baseline characteristics by cohort
| Measure |
RO7062931 0.3mg/kg
n=9 Participants
Participants will receive subcutaneously (SC) 0.3 milligram per kilogram (mg/kg) of RO7062931.
|
RO7062931 1.0mg/kg
n=8 Participants
Participants will receive subcutaneously (SC) 1.0 milligram per kilogram (mg/kg) of RO7062931.
|
RO7062931 2.0mg/kg
n=8 Participants
Participants will receive subcutaneously (SC) 2.0 milligram per kilogram (mg/kg) of RO7062931.
|
RO7062931 4.0mg/kg
n=8 Participants
Participants will receive subcutaneously (SC) 4.0 milligram per kilogram (mg/kg) of RO7062931.
|
Placebo
n=8 Participants
Participants will receive matching placebo.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
28.8 Years
STANDARD_DEVIATION 6.4 • n=5 Participants
|
29.3 Years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
29.8 Years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
29.6 Years
STANDARD_DEVIATION 9.2 • n=4 Participants
|
34.5 Years
STANDARD_DEVIATION 15. • n=21 Participants
|
30.2 Years
STANDARD_DEVIATION 10.7 • n=8 Participants
|
|
Sex: Female, Male
Female
|
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
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
41 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
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
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
41 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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
|
|
Race/Ethnicity, Customized
Asian/ Chinese
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
41 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Up to 16 weeksPopulation: The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not.
Adverse events of special interest for this study include the following: * Cases of an elevated ALT or AST in combination with either an elevated bilirubin or clinical jaundice * Suspected transmission of an infectious agent by the study drug * Severe injection site reactions * Renal adverse events
Outcome measures
| Measure |
RO7062931 0.3mg/kg
n=9 Participants
Participants will receive subcutaneously (SC) 0.3 milligram per kilogram (mg/kg) of RO7062931.
|
RO7062931 1.0mg/kg
n=8 Participants
Participants will receive subcutaneously (SC) 1.0 milligram per kilogram (mg/kg) of RO7062931.
|
RO7062931 2.0mg/kg
n=8 Participants
Participants will receive subcutaneously (SC) 2.0 milligram per kilogram (mg/kg) of RO7062931.
|
RO7062931 4.0mg/kg
n=8 Participants
Participants will receive subcutaneously (SC) 4.0 milligram per kilogram (mg/kg) of RO7062931.
|
Placebo
n=8 Participants
Participants will receive matching placebo.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Adverse Events and AEs of Special Interest
Adverse Events
|
66.7 Percentage of Participants
|
62.5 Percentage of Participants
|
62.5 Percentage of Participants
|
75.0 Percentage of Participants
|
87.5 Percentage of Participants
|
|
Percentage of Participants With Adverse Events and AEs of Special Interest
Adverse Events of Special interest (AESI)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 2, 8, 15, 29, 85Population: The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not.
Marked reference range has been predefined for each laboratory parameter. The marked reference range is broader than the standard reference range. Values falling outside the marked reference range that also represent a defined change from baseline will be considered marked laboratory abnormalities (i.e., potentially clinically relevant). If a baseline value is not available for a study subject, the midpoint of the standard reference range will be used as the study participant baseline value for the purposes of determining marked laboratory abnormalities.
Outcome measures
| Measure |
RO7062931 0.3mg/kg
n=9 Participants
Participants will receive subcutaneously (SC) 0.3 milligram per kilogram (mg/kg) of RO7062931.
|
RO7062931 1.0mg/kg
n=8 Participants
Participants will receive subcutaneously (SC) 1.0 milligram per kilogram (mg/kg) of RO7062931.
|
RO7062931 2.0mg/kg
n=8 Participants
Participants will receive subcutaneously (SC) 2.0 milligram per kilogram (mg/kg) of RO7062931.
|
RO7062931 4.0mg/kg
n=8 Participants
Participants will receive subcutaneously (SC) 4.0 milligram per kilogram (mg/kg) of RO7062931.
|
Placebo
n=8 Participants
Participants will receive matching placebo.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Marked Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation and Urinalysis Test Results
SGOT/AST High
|
11.1 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation and Urinalysis Test Results
Neutrophils, Total, Abs, Low
|
0 Percentage of Participants
|
0 Percentage of Participants
|
12.5 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Marked Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation and Urinalysis Test Results
Triglycerides High
|
0 Percentage of Participants
|
0 Percentage of Participants
|
12.5 Percentage of Participants
|
0 Percentage of Participants
|
12.5 Percentage of Participants
|
PRIMARY outcome
Timeframe: Baseline; pre-dose, 1 hour (h), 4, 8, 12h post-dose Day 1, 24h post-dose Day 2, 8, 15, 29, 85Population: The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not.
Table entries provide the percentage of Participants with a during treatment assessment abnormality in the direction specified regardless of this abnormality at baseline. Abnormalities reported in Participants with missing baseline values are included. Baseline is the Participant's last observation prior to initiation of study drug.
Outcome measures
| Measure |
RO7062931 0.3mg/kg
n=9 Participants
Participants will receive subcutaneously (SC) 0.3 milligram per kilogram (mg/kg) of RO7062931.
|
RO7062931 1.0mg/kg
n=8 Participants
Participants will receive subcutaneously (SC) 1.0 milligram per kilogram (mg/kg) of RO7062931.
|
RO7062931 2.0mg/kg
n=8 Participants
Participants will receive subcutaneously (SC) 2.0 milligram per kilogram (mg/kg) of RO7062931.
|
RO7062931 4.0mg/kg
n=8 Participants
Participants will receive subcutaneously (SC) 4.0 milligram per kilogram (mg/kg) of RO7062931.
|
Placebo
n=8 Participants
Participants will receive matching placebo.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Electrocardiogram (ECG) Abnormalities
QRS Duration High
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Electrocardiogram (ECG) Abnormalities
QT Duration Low
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Electrocardiogram (ECG) Abnormalities
QRS Duration Low
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Electrocardiogram (ECG) Abnormalities
PR Duration Low
|
11.1 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
12.5 Percentage of Participants
|
|
Percentage of Participants With Electrocardiogram (ECG) Abnormalities
PR Duration High
|
0 Percentage of Participants
|
25.0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
25.0 Percentage of Participants
|
|
Percentage of Participants With Electrocardiogram (ECG) Abnormalities
Heart Rate Low
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Electrocardiogram (ECG) Abnormalities
Heart Rate High
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Electrocardiogram (ECG) Abnormalities
QT Duration High
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Electrocardiogram (ECG) Abnormalities
QTcF - Fridericia's Correction Formula Low
|
0 Percentage of Participants
|
12.5 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Electrocardiogram (ECG) Abnormalities
QTcF - Fridericia's Correction Formula High
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
PRIMARY outcome
Timeframe: Baseline; pre-dose, 1 hour (h), 4, 8, 12h post-dose Day 1, 24h post-dose Day 2, 8, 15, 29, 85Population: The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not.
Table entries provide the percentage of Participants with a during treatment assessment abnormality in the direction specified regardless of this abnormality at baseline. Abnormalities reported in Participants with missing baseline values are included. Baseline is the Participant's last observation prior to initiation of study drug.
Outcome measures
| Measure |
RO7062931 0.3mg/kg
n=9 Participants
Participants will receive subcutaneously (SC) 0.3 milligram per kilogram (mg/kg) of RO7062931.
|
RO7062931 1.0mg/kg
n=8 Participants
Participants will receive subcutaneously (SC) 1.0 milligram per kilogram (mg/kg) of RO7062931.
|
RO7062931 2.0mg/kg
n=8 Participants
Participants will receive subcutaneously (SC) 2.0 milligram per kilogram (mg/kg) of RO7062931.
|
RO7062931 4.0mg/kg
n=8 Participants
Participants will receive subcutaneously (SC) 4.0 milligram per kilogram (mg/kg) of RO7062931.
|
Placebo
n=8 Participants
Participants will receive matching placebo.
|
|---|---|---|---|---|---|
|
Percentage of Participants With T-wave Abnormalities
Baseline Normal
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With T-wave Abnormalities
Day 1 / 1H
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With T-wave Abnormalities
Day 1 / 4H
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With T-wave Abnormalities
Day 1 / 8H
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With T-wave Abnormalities
Day 1 / 12H
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With T-wave Abnormalities
Day 2 / 24H
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With T-wave Abnormalities
Day 8 / 168H
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With T-wave Abnormalities
Follow-up Visit Day 15
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With T-wave Abnormalities
Follow-up Visit Day 29
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With T-wave Abnormalities
Follow-up Visit Day 85
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
PRIMARY outcome
Timeframe: Baseline; pre-dose, 1 hour (h), 4, 8, 12h post-dose Day 1, 24h post-dose Day 2, 8, 15, 29, 85Population: The Safety Population was defined as all Healthy Volunteers who have received at least one dose of the study medication, whether prematurely withdrawn from the study or not.
Table entries provide the percentage of Participants with a during treatment assessment abnormality in the direction specified regardless of this abnormality at baseline. Abnormalities reported in Participants with missing baseline values are included. Baseline is the Participant's last observation prior to initiation of study drug.
Outcome measures
| Measure |
RO7062931 0.3mg/kg
n=9 Participants
Participants will receive subcutaneously (SC) 0.3 milligram per kilogram (mg/kg) of RO7062931.
|
RO7062931 1.0mg/kg
n=8 Participants
Participants will receive subcutaneously (SC) 1.0 milligram per kilogram (mg/kg) of RO7062931.
|
RO7062931 2.0mg/kg
n=8 Participants
Participants will receive subcutaneously (SC) 2.0 milligram per kilogram (mg/kg) of RO7062931.
|
RO7062931 4.0mg/kg
n=8 Participants
Participants will receive subcutaneously (SC) 4.0 milligram per kilogram (mg/kg) of RO7062931.
|
Placebo
n=8 Participants
Participants will receive matching placebo.
|
|---|---|---|---|---|---|
|
Percentage of Participants With U-wave Abnormalities
Follow-up Visit Day 85
|
11.1 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
12.5 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With U-wave Abnormalities
Baseline Normal
|
22.2 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
25.0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With U-wave Abnormalities
Day 1 / 1H
|
11.1 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
25.0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With U-wave Abnormalities
Day 1 / 4H
|
22.2 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
12.5 Percentage of Participants
|
|
Percentage of Participants With U-wave Abnormalities
Day 1 / 8H
|
22.2 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
12.5 Percentage of Participants
|
|
Percentage of Participants With U-wave Abnormalities
Day 1 / 12H
|
22.2 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
12.5 Percentage of Participants
|
|
Percentage of Participants With U-wave Abnormalities
Day 2 / 24H
|
11.1 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
12.5 Percentage of Participants
|
|
Percentage of Participants With U-wave Abnormalities
Day 8 / 168H
|
12.5 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
12.5 Percentage of Participants
|
|
Percentage of Participants With U-wave Abnormalities
Follow-up Visit Day 15
|
11.1 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
12.5 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With U-wave Abnormalities
Follow-up Visit Day 29
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18h post-dose Day 1, 24, 30, 36h post-dose Day 2, Day 3, 4, 5, 6, 8Population: The PK analysis population included all healthy volunteers randomized and adherent to the protocol. Participants were excluded if they significantly violated the inclusion/exclusion criteria, deviated significantly from the protocol or if data were unavailable or incomplete. Data presented is only for participants included in the actual analysis
Observed Maximum Plasma Concentration were obtained after the participants received the RO7062931
Outcome measures
| Measure |
RO7062931 0.3mg/kg
n=9 Participants
Participants will receive subcutaneously (SC) 0.3 milligram per kilogram (mg/kg) of RO7062931.
|
RO7062931 1.0mg/kg
n=8 Participants
Participants will receive subcutaneously (SC) 1.0 milligram per kilogram (mg/kg) of RO7062931.
|
RO7062931 2.0mg/kg
n=8 Participants
Participants will receive subcutaneously (SC) 2.0 milligram per kilogram (mg/kg) of RO7062931.
|
RO7062931 4.0mg/kg
n=8 Participants
Participants will receive subcutaneously (SC) 4.0 milligram per kilogram (mg/kg) of RO7062931.
|
Placebo
Participants will receive matching placebo.
|
|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) for RO7062931
|
17.71 nmol/L
Geometric Coefficient of Variation 39.5
|
57.09 nmol/L
Geometric Coefficient of Variation 28.8
|
113.52 nmol/L
Geometric Coefficient of Variation 40.3
|
299.39 nmol/L
Geometric Coefficient of Variation 36.5
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18h post-dose Day 1, 24, 30, 36h post-dose Day 2, Day 3, 4, 5, 6, 8Population: The PK analysis population included all healthy volunteers randomized and adherent to the protocol. Participants were excluded if they significantly violated the inclusion/exclusion criteria, deviated significantly from the protocol or if data were unavailable or incomplete. Data presented is only for participants included in the actual analysis.
Time to reach the observed Maximum Plasma Concentration were obtained after the participants received the RO7062931.
Outcome measures
| Measure |
RO7062931 0.3mg/kg
n=9 Participants
Participants will receive subcutaneously (SC) 0.3 milligram per kilogram (mg/kg) of RO7062931.
|
RO7062931 1.0mg/kg
n=8 Participants
Participants will receive subcutaneously (SC) 1.0 milligram per kilogram (mg/kg) of RO7062931.
|
RO7062931 2.0mg/kg
n=8 Participants
Participants will receive subcutaneously (SC) 2.0 milligram per kilogram (mg/kg) of RO7062931.
|
RO7062931 4.0mg/kg
n=8 Participants
Participants will receive subcutaneously (SC) 4.0 milligram per kilogram (mg/kg) of RO7062931.
|
Placebo
Participants will receive matching placebo.
|
|---|---|---|---|---|---|
|
Time to Reach Maximum Plasma Concentration (Tmax) for RO7062931
|
1.50 h
Interval 1.0 to 3.0
|
2.38 h
Interval 1.0 to 3.9
|
2.87 h
Interval 1.9 to 3.9
|
2.85 h
Interval 1.4 to 4.0
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18h post-dose Day 1, 24, 30, 36h post-dose Day 2, Day 3, 4, 5, 6, 8Population: The PK analysis population included all healthy volunteers randomized and adherent to the protocol. Participants were excluded if they significantly violated the inclusion/exclusion criteria, deviated significantly from the protocol or if data were unavailable or incomplete. Data presented is only for participants included in the actual analysis.
Area Under the Plasma Concentration-time Curve Extrapolated to infinity was calculated based on Non-Compartment Analysis.
Outcome measures
| Measure |
RO7062931 0.3mg/kg
n=9 Participants
Participants will receive subcutaneously (SC) 0.3 milligram per kilogram (mg/kg) of RO7062931.
|
RO7062931 1.0mg/kg
n=8 Participants
Participants will receive subcutaneously (SC) 1.0 milligram per kilogram (mg/kg) of RO7062931.
|
RO7062931 2.0mg/kg
n=8 Participants
Participants will receive subcutaneously (SC) 2.0 milligram per kilogram (mg/kg) of RO7062931.
|
RO7062931 4.0mg/kg
n=8 Participants
Participants will receive subcutaneously (SC) 4.0 milligram per kilogram (mg/kg) of RO7062931.
|
Placebo
Participants will receive matching placebo.
|
|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) for RO7062931
|
95.26 h*nmol/L
Geometric Coefficient of Variation 9.0
|
349.75 h*nmol/L
Geometric Coefficient of Variation 14.8
|
791.99 h*nmol/L
Geometric Coefficient of Variation 19.9
|
2180.74 h*nmol/L
Geometric Coefficient of Variation 8.3
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18h post-dose Day 1, 24, 30, 36h post-dose Day 2, Day 3, 4, 5, 6, 8Population: The PK analysis population included all healthy volunteers randomized and adherent to the protocol. Participants were excluded if they significantly violated the inclusion/exclusion criteria, deviated significantly from the protocol or if data were unavailable or incomplete. Data presented is only for participants included in the actual analysis.
Area Under the Plasma Concentration-time Curve up to the last measurable concentration was calculated based on Non-Compartment Analysis
Outcome measures
| Measure |
RO7062931 0.3mg/kg
n=9 Participants
Participants will receive subcutaneously (SC) 0.3 milligram per kilogram (mg/kg) of RO7062931.
|
RO7062931 1.0mg/kg
n=8 Participants
Participants will receive subcutaneously (SC) 1.0 milligram per kilogram (mg/kg) of RO7062931.
|
RO7062931 2.0mg/kg
n=8 Participants
Participants will receive subcutaneously (SC) 2.0 milligram per kilogram (mg/kg) of RO7062931.
|
RO7062931 4.0mg/kg
n=8 Participants
Participants will receive subcutaneously (SC) 4.0 milligram per kilogram (mg/kg) of RO7062931.
|
Placebo
Participants will receive matching placebo.
|
|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time Zero Until the Last Quantifiable Time-Point (AUC0-last) for RO7062931
|
95.16 h*nmol/L
Geometric Coefficient of Variation 9.0
|
348.33 h*nmol/L
Geometric Coefficient of Variation 14.8
|
786.33 h*nmol/L
Geometric Coefficient of Variation 20.8
|
2114.90 h*nmol/L
Geometric Coefficient of Variation 10.9
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18h post-dose Day 1, 24, 30, 36h post-dose Day 2, Day 3, 4, 5, 6, 8Population: The PK analysis population included all healthy volunteers randomized and adherent to the protocol. Participants were excluded if they significantly violated the inclusion/exclusion criteria, deviated significantly from the protocol or if data were unavailable or incomplete. Data presented is only for participants included in the actual analysis.
Terminal Half-life was calculated based on Non-Compartment Analysis.
Outcome measures
| Measure |
RO7062931 0.3mg/kg
n=9 Participants
Participants will receive subcutaneously (SC) 0.3 milligram per kilogram (mg/kg) of RO7062931.
|
RO7062931 1.0mg/kg
n=8 Participants
Participants will receive subcutaneously (SC) 1.0 milligram per kilogram (mg/kg) of RO7062931.
|
RO7062931 2.0mg/kg
n=8 Participants
Participants will receive subcutaneously (SC) 2.0 milligram per kilogram (mg/kg) of RO7062931.
|
RO7062931 4.0mg/kg
n=8 Participants
Participants will receive subcutaneously (SC) 4.0 milligram per kilogram (mg/kg) of RO7062931.
|
Placebo
Participants will receive matching placebo.
|
|---|---|---|---|---|---|
|
Terminal Elimination Half-Life (t1/2) for RO7062931
|
3.87 h
Geometric Coefficient of Variation 44.6
|
66.59 h
Geometric Coefficient of Variation 38.6
|
81.83 h
Geometric Coefficient of Variation 24.0
|
88.78 h
Geometric Coefficient of Variation 18.4
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18h post-dose Day 1, 24, 30, 36h post-dose Day 2, Day 3, 4, 5, 6, 8Population: The PK analysis population included all healthy volunteers randomized and adherent to the protocol. Participants were excluded if they significantly violated the inclusion/exclusion criteria, deviated significantly from the protocol or if data were unavailable or incomplete. Data presented is only for participants included in the actual analysis.
Apparent oral clearance was calculated from Dose/AUCinf.
Outcome measures
| Measure |
RO7062931 0.3mg/kg
n=9 Participants
Participants will receive subcutaneously (SC) 0.3 milligram per kilogram (mg/kg) of RO7062931.
|
RO7062931 1.0mg/kg
n=8 Participants
Participants will receive subcutaneously (SC) 1.0 milligram per kilogram (mg/kg) of RO7062931.
|
RO7062931 2.0mg/kg
n=8 Participants
Participants will receive subcutaneously (SC) 2.0 milligram per kilogram (mg/kg) of RO7062931.
|
RO7062931 4.0mg/kg
n=8 Participants
Participants will receive subcutaneously (SC) 4.0 milligram per kilogram (mg/kg) of RO7062931.
|
Placebo
Participants will receive matching placebo.
|
|---|---|---|---|---|---|
|
Apparent Clearance (CL/F) for RO7062931
|
29.24 L/h
Geometric Coefficient of Variation 11.4
|
27.23 L/h
Geometric Coefficient of Variation 18.8
|
25.24 L/h
Geometric Coefficient of Variation 18.5
|
17.46 L/h
Geometric Coefficient of Variation 8.4
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18h post-dose Day 1, 24, 30, 36h post-dose Day 2, Day 3, 4, 5, 6, 8Population: The PK analysis population included all healthy volunteers randomized and adherent to the protocol. Participants were excluded if they significantly violated the inclusion/exclusion criteria, deviated significantly from the protocol or if data were unavailable or incomplete. Data presented is only for participants included in the actual analysis.
Apparent volume of distribution was calculated from Dose/AUCinf
Outcome measures
| Measure |
RO7062931 0.3mg/kg
n=9 Participants
Participants will receive subcutaneously (SC) 0.3 milligram per kilogram (mg/kg) of RO7062931.
|
RO7062931 1.0mg/kg
n=8 Participants
Participants will receive subcutaneously (SC) 1.0 milligram per kilogram (mg/kg) of RO7062931.
|
RO7062931 2.0mg/kg
n=8 Participants
Participants will receive subcutaneously (SC) 2.0 milligram per kilogram (mg/kg) of RO7062931.
|
RO7062931 4.0mg/kg
n=8 Participants
Participants will receive subcutaneously (SC) 4.0 milligram per kilogram (mg/kg) of RO7062931.
|
Placebo
Participants will receive matching placebo.
|
|---|---|---|---|---|---|
|
Apparent Volume of Distribution (Vz/F) for RO7062931
|
163.27 L
Geometric Coefficient of Variation 45.7
|
2616.31 L
Geometric Coefficient of Variation 35.8
|
2980.22 L
Geometric Coefficient of Variation 40.0
|
2235.97 L
Geometric Coefficient of Variation 15.3
|
—
|
SECONDARY outcome
Timeframe: (0-4), (4-8), (8-12), (12-24)h post-dose Day 1Population: The PK analysis population included all healthy volunteers randomized and adherent to the protocol. Participants were excluded if they significantly violated the inclusion/exclusion criteria, deviated significantly from the protocol or if data were unavailable or incomplete. Data presented is only for participants included in the actual analysis.
Ae: cumulative amount of drug excreted in urine over a 24 hour period or over defined time periods linked to the pools of urine collected.
Outcome measures
| Measure |
RO7062931 0.3mg/kg
n=9 Participants
Participants will receive subcutaneously (SC) 0.3 milligram per kilogram (mg/kg) of RO7062931.
|
RO7062931 1.0mg/kg
n=8 Participants
Participants will receive subcutaneously (SC) 1.0 milligram per kilogram (mg/kg) of RO7062931.
|
RO7062931 2.0mg/kg
n=8 Participants
Participants will receive subcutaneously (SC) 2.0 milligram per kilogram (mg/kg) of RO7062931.
|
RO7062931 4.0mg/kg
n=8 Participants
Participants will receive subcutaneously (SC) 4.0 milligram per kilogram (mg/kg) of RO7062931.
|
Placebo
Participants will receive matching placebo.
|
|---|---|---|---|---|---|
|
Cumulative Amount of RO7062931 Excreted in Urine (Ae)
Ae 0-8h
|
35.35 nmol
Standard Deviation 6.64
|
133.79 nmol
Standard Deviation 29.09
|
326.90 nmol
Standard Deviation 106.77
|
1433.92 nmol
Standard Deviation 595.77
|
—
|
|
Cumulative Amount of RO7062931 Excreted in Urine (Ae)
Ae 0-24h
|
41.88 nmol
Standard Deviation 6.69
|
147.88 nmol
Standard Deviation 40.78
|
545.61 nmol
Standard Deviation 139.56
|
1977.71 nmol
Standard Deviation 513.27
|
—
|
SECONDARY outcome
Timeframe: 0-24h h post-dose Day 1Population: The PK analysis population included all healthy volunteers randomized and adherent to the protocol. Participants were excluded if they significantly violated the inclusion/exclusion criteria, deviated significantly from the protocol or if data were unavailable or incomplete. Data presented is only for participants included in the actual analysis.
The fraction of cumulative amount in urine were calculated based on Ae/Dose
Outcome measures
| Measure |
RO7062931 0.3mg/kg
n=9 Participants
Participants will receive subcutaneously (SC) 0.3 milligram per kilogram (mg/kg) of RO7062931.
|
RO7062931 1.0mg/kg
n=8 Participants
Participants will receive subcutaneously (SC) 1.0 milligram per kilogram (mg/kg) of RO7062931.
|
RO7062931 2.0mg/kg
n=8 Participants
Participants will receive subcutaneously (SC) 2.0 milligram per kilogram (mg/kg) of RO7062931.
|
RO7062931 4.0mg/kg
n=8 Participants
Participants will receive subcutaneously (SC) 4.0 milligram per kilogram (mg/kg) of RO7062931.
|
Placebo
Participants will receive matching placebo.
|
|---|---|---|---|---|---|
|
Fraction of Cumulative Amount of RO7062931 Excreted in the Urine Over Total Dose (Fe)
|
1.50 Percentage
Standard Deviation 0.20
|
1.63 Percentage
Standard Deviation 0.30
|
2.79 Percentage
Standard Deviation 0.72
|
5.26 Percentage
Standard Deviation 1.65
|
—
|
Adverse Events
RO7062931 0.3mg/kg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
RO7062931 1.0mg/kg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
RO7062931 2.0mg/kg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
RO7062931 4.0mg/kg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
RO7062931 0.3mg/kg
n=9 participants at risk
Participants will receive subcutaneously (SC) 0.3 milligram per kilogram (mg/kg) of RO7062931.
|
RO7062931 1.0mg/kg
n=8 participants at risk
Participants will receive subcutaneously (SC) 1.0 milligram per kilogram (mg/kg) of RO7062931.
|
RO7062931 2.0mg/kg
n=8 participants at risk
Participants will receive subcutaneously (SC) 2.0 milligram per kilogram (mg/kg) of RO7062931.
|
RO7062931 4.0mg/kg
n=8 participants at risk
Participants will receive subcutaneously (SC) 4.0 milligram per kilogram (mg/kg) of RO7062931.
|
Placebo
n=8 participants at risk
Participants will receive matching placebo.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/9 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
25.0%
2/8 • Number of events 2 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
11.1%
1/9 • Number of events 1 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/9 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
12.5%
1/8 • Number of events 1 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
12.5%
1/8 • Number of events 1 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/9 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
12.5%
1/8 • Number of events 1 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/9 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
12.5%
1/8 • Number of events 1 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
|
Gastrointestinal disorders
Noninfective gingivitis
|
11.1%
1/9 • Number of events 1 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
|
Gastrointestinal disorders
Tongue cyst
|
0.00%
0/9 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
12.5%
1/8 • Number of events 1 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
|
Gastrointestinal disorders
Toothache
|
11.1%
1/9 • Number of events 1 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
|
General disorders
Catheter site bruise
|
0.00%
0/9 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
12.5%
1/8 • Number of events 2 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
|
General disorders
Injection site reaction
|
0.00%
0/9 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
25.0%
2/8 • Number of events 2 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
12.5%
1/8 • Number of events 1 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
50.0%
4/8 • Number of events 5 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
12.5%
1/8 • Number of events 1 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
|
General disorders
Vessel puncture site bruise
|
11.1%
1/9 • Number of events 1 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
12.5%
1/8 • Number of events 1 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
|
General disorders
Vessel puncture site erythema
|
0.00%
0/9 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
12.5%
1/8 • Number of events 1 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/9 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
12.5%
1/8 • Number of events 1 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
|
General disorders
Vessel puncture site pruritus
|
0.00%
0/9 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
12.5%
1/8 • Number of events 1 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/9 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
12.5%
1/8 • Number of events 2 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/9 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
12.5%
1/8 • Number of events 1 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
|
Infections and infestations
Influenza
|
0.00%
0/9 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
37.5%
3/8 • Number of events 3 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
12.5%
1/8 • Number of events 1 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
25.0%
2/8 • Number of events 2 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
37.5%
3/8 • Number of events 3 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
|
Infections and infestations
Otitis media
|
0.00%
0/9 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
12.5%
1/8 • Number of events 1 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
|
Infections and infestations
Upper respiratory tract infection
|
11.1%
1/9 • Number of events 1 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
11.1%
1/9 • Number of events 1 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/9 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
12.5%
1/8 • Number of events 2 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
|
Injury, poisoning and procedural complications
Injection related reaction
|
0.00%
0/9 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
12.5%
1/8 • Number of events 1 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/9 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
12.5%
1/8 • Number of events 1 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/9 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
12.5%
1/8 • Number of events 1 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/9 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
12.5%
1/8 • Number of events 1 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
11.1%
1/9 • Number of events 1 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/9 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
12.5%
1/8 • Number of events 1 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
|
Nervous system disorders
Headache
|
11.1%
1/9 • Number of events 1 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
12.5%
1/8 • Number of events 1 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
12.5%
1/8 • Number of events 1 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
12.5%
1/8 • Number of events 1 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
|
Nervous system disorders
Presyncope
|
11.1%
1/9 • Number of events 1 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.1%
1/9 • Number of events 1 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
12.5%
1/8 • Number of events 2 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
11.1%
1/9 • Number of events 1 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/9 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
12.5%
1/8 • Number of events 2 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
12.5%
1/8 • Number of events 1 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
|
11.1%
1/9 • Number of events 1 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
11.1%
1/9 • Number of events 1 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/9 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
12.5%
1/8 • Number of events 1 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
|
Skin and subcutaneous tissue disorders
Rash
|
22.2%
2/9 • Number of events 2 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
0.00%
0/8 • Baseline up to 14 months
Number of events includes all occurrences. The Safety Population includes all participants who received study drug or placebo.
|
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