Trial Outcomes & Findings for A Study of ARC-521 Injection in Normal Adult Volunteers and Patients With Chronic Hepatitis B (CHB) (NCT NCT02797522)
NCT ID: NCT02797522
Last Updated: 2026-01-12
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
47 participants
Primary outcome timeframe
Through 48 hours post-dose on Day 1
Results posted on
2026-01-12
Participant Flow
Participant milestones
| Measure |
NHV Participants: Cohort 1
Normal healthy volunteer (NHV) participants administered a single dose of ARC-521 Injection at a dose of 0.6 mg/kg.
|
NHV Participants: Cohort 2
NHV participants administered a single dose of ARC-521 Injection at a dose of 1 mg/kg.
|
NHV Participants: Cohort 3
NHV participants administered a single dose of ARC-521 Injection at a dose of 2 mg/kg.
|
NHV Participants: Cohort 4
NHV participants administered a single dose of ARC-521 Injection at a dose of 4 mg/kg.
|
NHV Participants: Cohort 5
NHV participants administered a single dose of ARC-521 Injection at a dose of 5 mg/kg.
|
NHV Participants: Cohort 6
NHV participants administered a single dose of ARC-521 Injection at a dose of 6 mg/kg.
|
NHV Participants: Placebo
NHV participants administered 0.9% normal saline to match ARC-521 Injection at doses of 0.6, 1, 2, 4, 5 and 6 mg/kg.
|
CHB Participants: Cohort 3b
Treatment-naive participants with chronic hepatitis B (CHB) administered 3 doses of ARC-521 Injection at 2 mg/kg once every 4 weeks. Participants are treatment-naive if they have not been on continual nucleoside analog (NUC) therapy (any NUC) for at least 6 months prior to screening (or have never been on NUCs).
|
CHB Participants: Cohort 4b
Treatment-naive participants with CHB administered 3 doses of ARC-521 Injection at 4 mg/kg once every 4 weeks. Participants are treatment-naive if they have not been on continual NUC therapy (any NUC) for at least 6 months prior to screening (or have never been on NUCs).
|
CHB Participants: Cohort 3c
Participants with CHB currently on NUCs (entecavir or tenofovir for at least 6 months) administered 3 doses of ARC-521 Injection at 2 mg/kg once every 4 weeks.
|
CHB Participants: Cohort 4c
Participants with CHB currently on NUCs (entecavir or tenofovir for at least 6 months) administered 3 doses of ARC-521 Injection at 4 mg/kg once every 4 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
2
|
4
|
1
|
|
Overall Study
STARTED
|
4
|
4
|
4
|
4
|
4
|
4
|
12
|
4
|
2
|
4
|
1
|
|
Overall Study
COMPLETED
|
4
|
4
|
4
|
4
|
4
|
4
|
12
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
NHV Participants: Cohort 1
Normal healthy volunteer (NHV) participants administered a single dose of ARC-521 Injection at a dose of 0.6 mg/kg.
|
NHV Participants: Cohort 2
NHV participants administered a single dose of ARC-521 Injection at a dose of 1 mg/kg.
|
NHV Participants: Cohort 3
NHV participants administered a single dose of ARC-521 Injection at a dose of 2 mg/kg.
|
NHV Participants: Cohort 4
NHV participants administered a single dose of ARC-521 Injection at a dose of 4 mg/kg.
|
NHV Participants: Cohort 5
NHV participants administered a single dose of ARC-521 Injection at a dose of 5 mg/kg.
|
NHV Participants: Cohort 6
NHV participants administered a single dose of ARC-521 Injection at a dose of 6 mg/kg.
|
NHV Participants: Placebo
NHV participants administered 0.9% normal saline to match ARC-521 Injection at doses of 0.6, 1, 2, 4, 5 and 6 mg/kg.
|
CHB Participants: Cohort 3b
Treatment-naive participants with chronic hepatitis B (CHB) administered 3 doses of ARC-521 Injection at 2 mg/kg once every 4 weeks. Participants are treatment-naive if they have not been on continual nucleoside analog (NUC) therapy (any NUC) for at least 6 months prior to screening (or have never been on NUCs).
|
CHB Participants: Cohort 4b
Treatment-naive participants with CHB administered 3 doses of ARC-521 Injection at 4 mg/kg once every 4 weeks. Participants are treatment-naive if they have not been on continual NUC therapy (any NUC) for at least 6 months prior to screening (or have never been on NUCs).
|
CHB Participants: Cohort 3c
Participants with CHB currently on NUCs (entecavir or tenofovir for at least 6 months) administered 3 doses of ARC-521 Injection at 2 mg/kg once every 4 weeks.
|
CHB Participants: Cohort 4c
Participants with CHB currently on NUCs (entecavir or tenofovir for at least 6 months) administered 3 doses of ARC-521 Injection at 4 mg/kg once every 4 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Study Terminated by Sponsor
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
2
|
4
|
1
|
Baseline Characteristics
A Study of ARC-521 Injection in Normal Adult Volunteers and Patients With Chronic Hepatitis B (CHB)
Baseline characteristics by cohort
| Measure |
NHV Participants: Cohort 1
n=4 Participants
NHV participants administered a single dose of ARC-521 Injection at a dose of 0.6 mg/kg.
|
NHV Participants: Cohort 2
n=4 Participants
NHV participants administered a single dose of ARC-521 Injection at a dose of 1 mg/kg.
|
NHV Participants: Cohort 3
n=4 Participants
NHV participants administered a single dose of ARC-521 Injection at a dose of 2 mg/kg.
|
NHV Participants: Cohort 4
n=4 Participants
NHV participants administered a single dose of ARC-521 Injection at a dose of 4 mg/kg.
|
NHV Participants: Cohort 5
n=4 Participants
NHV participants administered a single dose of ARC-521 Injection at a dose of 5 mg/kg.
|
NHV Participants: Cohort 6
n=4 Participants
NHV participants administered a single dose of ARC-521 Injection at a dose of 6 mg/kg.
|
NHV Participants: Placebo
n=12 Participants
NHV participants administered 0.9% normal saline to match ARC-521 Injection at doses of 0.6, 1, 2, 4, 5 and 6 mg/kg.
|
CHB Participants: Cohort 3b
n=4 Participants
Treatment-naive participants with CHB administered 3 doses of ARC-521 Injection at 2 mg/kg once every 4 weeks. Participants are treatment-naive if they have not been on continual NUC therapy (any NUC) for at least 6 months prior to screening (or have never been on NUCs).
|
CHB Participants: Cohort 4b
n=2 Participants
Treatment-naive participants with CHB administered 3 doses of ARC-521Injection at 4 mg/kg once every 4 weeks. Participants are treatment-naive if they have not been on continual NUC therapy (any NUC) for at least 6 months prior to screening (or have never been on NUCs).
|
CHB Participants: Cohort 3c
n=4 Participants
Participants with CHB currently on NUCs (entecavir or tenofovir for at least 6 months) administered 3 doses of ARC-521 Injection at 2 mg/kg once every 4 weeks.
|
CHB Participants: Cohort 4c
n=1 Participants
Participants with CHB currently on NUCs (entecavir or tenofovir for at least 6 months) administered 3 doses of ARC-521 Injection at 4 mg/kg once every 4 weeks.
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
26.8 years
STANDARD_DEVIATION 8.26 • n=9 Participants
|
27.8 years
STANDARD_DEVIATION 10.90 • n=6 Participants
|
23.3 years
STANDARD_DEVIATION 3.30 • n=9 Participants
|
22.5 years
STANDARD_DEVIATION 1.29 • n=17 Participants
|
22.3 years
STANDARD_DEVIATION 3.59 • n=16 Participants
|
23.5 years
STANDARD_DEVIATION 4.04 • n=82 Participants
|
28.3 years
STANDARD_DEVIATION 5.69 • n=13 Participants
|
46.3 years
STANDARD_DEVIATION 10.63 • n=335 Participants
|
44.5 years
STANDARD_DEVIATION 14.85 • n=451 Participants
|
44.3 years
STANDARD_DEVIATION 3.69 • n=6 Participants
|
36.0 years
STANDARD_DEVIATION NA • n=6 Participants
|
30.0 years
STANDARD_DEVIATION 8.49 • n=6 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=9 Participants
|
3 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
1 Participants
n=17 Participants
|
1 Participants
n=16 Participants
|
3 Participants
n=82 Participants
|
7 Participants
n=13 Participants
|
0 Participants
n=335 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
18 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
3 Participants
n=9 Participants
|
3 Participants
n=17 Participants
|
3 Participants
n=16 Participants
|
1 Participants
n=82 Participants
|
5 Participants
n=13 Participants
|
4 Participants
n=335 Participants
|
2 Participants
n=451 Participants
|
4 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
29 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug through Day 29 (± 1 day)An adverse event (AE) is any untoward medical occurrence which does not necessarily have a causal relationship with this treatment. A serious AE is any AE that: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is a medically important event or reaction.Events were categorized as mild, moderate or severe. TEAEs were defined as all AEs starting or worsening after commencement of treatment with investigational product. A treatment-related TEAE was one whose relationship to treatment was noted as unlikely, possibly, or probably related.
Outcome measures
| Measure |
NHV Participants: Placebo
n=12 Participants
NHV participants administered 0.9% normal saline to match ARC-521 Injection at doses of 0.6, 1, 2, 4, 5 and 6 mg/kg.
|
NHV Participants: Cohort 1
n=4 Participants
NHV participants administered a single dose of ARC-521 Injection at a dose of 0.6 mg/kg.
|
NHV Participants: Cohort 2
n=4 Participants
NHV participants administered a single dose of ARC-521 Injection at a dose of 1 mg/kg.
|
NHV Participants: Cohort 3
n=4 Participants
NHV participants administered a single dose of ARC-521 Injection at a dose of 2 mg/kg.
|
NHV Participants: Cohort 4
n=4 Participants
NHV participants administered a single dose of ARC-521 Injection at a dose of 4 mg/kg.
|
NHV Participants: Cohort 5
n=4 Participants
NHV participants administered a single dose of ARC-521 Injection at a dose of 5 mg/kg.
|
NHV Participants: Cohort 6
n=4 Participants
NHV participants administered a single dose of ARC-521 Injection at a dose of 6 mg/kg.
|
CHB Participants: Cohort 3b
Treatment-naive participants with CHB administered 3 doses of ARC-521 Injection at 2 mg/kg once every 4 weeks. Participants are treatment-naive if they have not been on continual NUC therapy (any NUC) for at least 6 months prior to screening (or have never been on NUCs).
|
CHB Participants: Cohort 4b
Treatment-naive participants with CHB administered 3 doses of ARC-521Injection at 4 mg/kg once every 4 weeks. Participants are treatment-naive if they have not been on continual NUC therapy (any NUC) for at least 6 months prior to screening (or have never been on NUCs).
|
CHB Participants: Cohort 3c
Participants with CHB currently on NUCs (entecavir or tenofovir for at least 6 months) administered 3 doses of ARC-521 Injection at 2 mg/kg once every 4 weeks.
|
CHB Participants: Cohort 4c
Participants with CHB currently on NUCs (entecavir or tenofovir for at least 6 months) administered 3 doses of ARC-521 Injection at 4 mg/kg once every 4 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs): Healthy Volunteers
>/= 1 TEAE
|
10 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs): Healthy Volunteers
>/= 1 Serious TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs): Healthy Volunteers
>/= 1 Related TEAE
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs): Healthy Volunteers
>/= 1 Related Serious TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From first dose of study drug through Day 142 (± 3 days)An AE is any untoward medical occurrence which does not necessarily have a causal relationship with this treatment. A serious AE is any AE that: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is a medically important event or reaction.Events were categorized as mild, moderate or severe. TEAEs were defined as all AEs starting or worsening after commencement of treatment with investigational product. A treatment-related TEAE was one whose relationship to treatment was noted as unlikely, possibly, or probably related.
Outcome measures
| Measure |
NHV Participants: Placebo
NHV participants administered 0.9% normal saline to match ARC-521 Injection at doses of 0.6, 1, 2, 4, 5 and 6 mg/kg.
|
NHV Participants: Cohort 1
n=4 Participants
NHV participants administered a single dose of ARC-521 Injection at a dose of 0.6 mg/kg.
|
NHV Participants: Cohort 2
n=2 Participants
NHV participants administered a single dose of ARC-521 Injection at a dose of 1 mg/kg.
|
NHV Participants: Cohort 3
n=4 Participants
NHV participants administered a single dose of ARC-521 Injection at a dose of 2 mg/kg.
|
NHV Participants: Cohort 4
n=1 Participants
NHV participants administered a single dose of ARC-521 Injection at a dose of 4 mg/kg.
|
NHV Participants: Cohort 5
NHV participants administered a single dose of ARC-521 Injection at a dose of 5 mg/kg.
|
NHV Participants: Cohort 6
NHV participants administered a single dose of ARC-521 Injection at a dose of 6 mg/kg.
|
CHB Participants: Cohort 3b
Treatment-naive participants with CHB administered 3 doses of ARC-521 Injection at 2 mg/kg once every 4 weeks. Participants are treatment-naive if they have not been on continual NUC therapy (any NUC) for at least 6 months prior to screening (or have never been on NUCs).
|
CHB Participants: Cohort 4b
Treatment-naive participants with CHB administered 3 doses of ARC-521Injection at 4 mg/kg once every 4 weeks. Participants are treatment-naive if they have not been on continual NUC therapy (any NUC) for at least 6 months prior to screening (or have never been on NUCs).
|
CHB Participants: Cohort 3c
Participants with CHB currently on NUCs (entecavir or tenofovir for at least 6 months) administered 3 doses of ARC-521 Injection at 2 mg/kg once every 4 weeks.
|
CHB Participants: Cohort 4c
Participants with CHB currently on NUCs (entecavir or tenofovir for at least 6 months) administered 3 doses of ARC-521 Injection at 4 mg/kg once every 4 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With TEAEs: CHB Participants
>/= 1 TEAE
|
—
|
2 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With TEAEs: CHB Participants
>/= 1 Serious TEAE
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With TEAEs: CHB Participants
>/= 1 Related TEAE
|
—
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With TEAEs: CHB Participants
>/= 1 Related Serious TEAE
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Through 48 hours post-dose on Day 1Population: Analysis was not planned or conducted per statistical analysis plan (SAP) due to study termination.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Through 48 hours post-dose on Day 1Population: Analysis was not planned or conducted per SAP due to study termination.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Through 48 hours post-dose on Day 1Population: Analysis was not planned or conducted per SAP due to study termination.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Through 48 hours post-dose on Day 1Population: Analysis was not planned or conducted per SAP due to study termination.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Through 48 hrs post-dose on Day 1Population: Analysis was not planned or conducted per SAP due to study termination.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Through 48 hours post-dose on Day 1Population: Analysis was not planned or conducted per SAP due to study termination.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Through 48 hours post-dose on Day 1Population: Analysis was not planned or conducted per SAP due to study termination.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Through 48 hours post-dose on Day 1Population: Analysis was not planned or conducted per SAP due to study termination.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline to Day 142Population: Analysis was not planned or conducted per SAP due to study termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through 24 hours post-dose (Day 1 for NHVs, and Days 1, 29 & 57 for CHB participants)Population: Analysis was not planned or conducted per SAP due to study termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through 24 hours post-dose (Day 1 for NHVs, and Days 1, 29 & 57 for CHB participants)Population: Analysis was not planned or conducted per SAP due to study termination.
Outcome measures
Outcome data not reported
Adverse Events
NHV Participants: Cohort 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
NHV Participants: Cohort 2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
NHV Participants: Cohort 3
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
NHV Participants: Cohort 4
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
NHV Participants: Cohort 5
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
NHV Participants: Cohort 6
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
NHV Participants: Placebo
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
CHB Participants: Cohort 3b
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
CHB Participants: Cohort 4b
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
CHB Participants: Cohort 3c
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
CHB Participants: Cohort 4c
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NHV Participants: Cohort 1
n=4 participants at risk
NHV participants administered a single dose of ARC-521 Injection at a dose of 0.6 mg/kg.
|
NHV Participants: Cohort 2
n=4 participants at risk
NHV participants administered a single dose of ARC-521 Injection at a dose of 1 mg/kg.
|
NHV Participants: Cohort 3
n=4 participants at risk
NHV participants administered a single dose of ARC-521 Injection at a dose of 2 mg/kg.
|
NHV Participants: Cohort 4
n=4 participants at risk
NHV participants administered a single dose of ARC-521 Injection at a dose of 4 mg/kg.
|
NHV Participants: Cohort 5
n=4 participants at risk
NHV participants administered a single dose of ARC-521 Injection at a dose of 5 mg/kg.
|
NHV Participants: Cohort 6
n=4 participants at risk
NHV participants administered a single dose of ARC-521 Injection at a dose of 6 mg/kg.
|
NHV Participants: Placebo
n=12 participants at risk
NHV participants administered 0.9% normal saline to match ARC-521 Injection at doses of 0.6, 1, 2, 4, 5 and 6 mg/kg.
|
CHB Participants: Cohort 3b
n=4 participants at risk
Treatment-naive participants with CHB administered 3 doses of ARC-521 Injection at 2 mg/kg once every 4 weeks. Participants are treatment-naive if they have not been on continual NUC therapy (any NUC) for at least 6 months prior to screening (or have never been on NUCs).
|
CHB Participants: Cohort 4b
n=2 participants at risk
Treatment-naive participants with CHB administered 3 doses of ARC-521Injection at 4 mg/kg once every 4 weeks. Participants are treatment-naive if they have not been on continual NUC therapy (any NUC) for at least 6 months prior to screening (or have never been on NUCs).
|
CHB Participants: Cohort 3c
n=4 participants at risk
Participants with CHB currently on NUCs (entecavir or tenofovir for at least 6 months) administered 3 doses of ARC-521 Injection at 2 mg/kg once every 4 weeks.
|
CHB Participants: Cohort 4c
n=1 participants at risk
Participants with CHB currently on NUCs (entecavir or tenofovir for at least 6 months) administered 3 doses of ARC-521 Injection at 4 mg/kg once every 4 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Investigations
Transaminases increased
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/12 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
50.0%
1/2 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/1 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
Other adverse events
| Measure |
NHV Participants: Cohort 1
n=4 participants at risk
NHV participants administered a single dose of ARC-521 Injection at a dose of 0.6 mg/kg.
|
NHV Participants: Cohort 2
n=4 participants at risk
NHV participants administered a single dose of ARC-521 Injection at a dose of 1 mg/kg.
|
NHV Participants: Cohort 3
n=4 participants at risk
NHV participants administered a single dose of ARC-521 Injection at a dose of 2 mg/kg.
|
NHV Participants: Cohort 4
n=4 participants at risk
NHV participants administered a single dose of ARC-521 Injection at a dose of 4 mg/kg.
|
NHV Participants: Cohort 5
n=4 participants at risk
NHV participants administered a single dose of ARC-521 Injection at a dose of 5 mg/kg.
|
NHV Participants: Cohort 6
n=4 participants at risk
NHV participants administered a single dose of ARC-521 Injection at a dose of 6 mg/kg.
|
NHV Participants: Placebo
n=12 participants at risk
NHV participants administered 0.9% normal saline to match ARC-521 Injection at doses of 0.6, 1, 2, 4, 5 and 6 mg/kg.
|
CHB Participants: Cohort 3b
n=4 participants at risk
Treatment-naive participants with CHB administered 3 doses of ARC-521 Injection at 2 mg/kg once every 4 weeks. Participants are treatment-naive if they have not been on continual NUC therapy (any NUC) for at least 6 months prior to screening (or have never been on NUCs).
|
CHB Participants: Cohort 4b
n=2 participants at risk
Treatment-naive participants with CHB administered 3 doses of ARC-521Injection at 4 mg/kg once every 4 weeks. Participants are treatment-naive if they have not been on continual NUC therapy (any NUC) for at least 6 months prior to screening (or have never been on NUCs).
|
CHB Participants: Cohort 3c
n=4 participants at risk
Participants with CHB currently on NUCs (entecavir or tenofovir for at least 6 months) administered 3 doses of ARC-521 Injection at 2 mg/kg once every 4 weeks.
|
CHB Participants: Cohort 4c
n=1 participants at risk
Participants with CHB currently on NUCs (entecavir or tenofovir for at least 6 months) administered 3 doses of ARC-521 Injection at 4 mg/kg once every 4 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
25.0%
1/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
8.3%
1/12 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/2 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/1 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
|
Ear and labyrinth disorders
Ear deformity acquired
|
25.0%
1/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/12 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/2 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/1 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
25.0%
1/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/12 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/2 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/1 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
25.0%
1/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
8.3%
1/12 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/2 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/1 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
25.0%
1/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
25.0%
1/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/12 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/2 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
25.0%
1/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
100.0%
1/1 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
|
Gastrointestinal disorders
Sensitivity of teeth
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
25.0%
1/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/12 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/2 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/1 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
25.0%
1/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/12 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/2 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/1 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
|
General disorders
Catheter site bruise
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
25.0%
1/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
8.3%
1/12 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/2 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
25.0%
1/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/1 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
|
General disorders
Catheter site pain
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
8.3%
1/12 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/2 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/1 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
|
General disorders
Catheter site swelling
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
25.0%
1/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/12 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/2 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/1 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
25.0%
1/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/12 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/2 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/1 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
|
Infections and infestations
Paronychia
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
25.0%
1/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/12 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/2 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/1 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
8.3%
1/12 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/2 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/1 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
25.0%
1/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/12 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/2 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/1 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
|
Vascular disorders
Haematoma
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
25.0%
1/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
8.3%
1/12 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
25.0%
1/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/2 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/1 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
25.0%
1/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
8.3%
1/12 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/2 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/1 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
25.0%
1/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/12 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/2 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/1 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
8.3%
1/12 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/2 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/1 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
25.0%
1/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/12 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/2 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
100.0%
1/1 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
25.0%
1/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/12 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/2 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/1 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
25.0%
1/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
25.0%
1/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
8.3%
1/12 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/2 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/1 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
16.7%
2/12 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/2 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/1 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
8.3%
1/12 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/2 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
100.0%
1/1 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
25.0%
1/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
25.0%
1/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
25.0%
1/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
16.7%
2/12 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/2 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/1 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
|
Nervous system disorders
Lethargy
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
25.0%
1/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
50.0%
2/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
8.3%
1/12 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/2 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/1 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
|
Nervous system disorders
Presyncope
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
25.0%
1/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
25.0%
1/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
25.0%
1/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/12 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/2 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/1 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
25.0%
1/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
25.0%
1/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/12 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/2 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/1 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
8.3%
1/12 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/2 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/1 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
|
Vascular disorders
Hot flush
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
25.0%
1/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/12 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/2 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/1 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
|
General disorders
Fatigue
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/12 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/2 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
25.0%
1/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/1 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
|
General disorders
Influenza like illness
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/12 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/2 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
25.0%
1/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/1 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/12 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
25.0%
1/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/2 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/1 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/12 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/2 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
100.0%
1/1 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/12 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
25.0%
1/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/2 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/1 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/12 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/2 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
25.0%
1/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/1 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/12 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/2 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
25.0%
1/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/1 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
|
Nervous system disorders
Migraine
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/12 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/2 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
25.0%
1/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/1 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/12 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/2 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
25.0%
1/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/1 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/12 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/2 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
25.0%
1/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/1 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/12 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/2 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
25.0%
1/4 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
0.00%
0/1 • NHV: from first dose of study drug through Day 29 (± 1 days); CHB participants:from first dose of study drug through Day 142 (± 3 days)
|
Additional Information
Chief Operating Officer
Arrowhead Pharmaceuticals, Inc.
Phone: 626-304-3400
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place