Trial Outcomes & Findings for Study of VIR-3434 in Healthy Volunteers and Patients With Chronic Hepatitis B Virus Infection (NCT NCT04423393)
NCT ID: NCT04423393
Last Updated: 2024-10-08
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
113 participants
Primary outcome timeframe
Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
Results posted on
2024-10-08
Participant Flow
Participant milestones
| Measure |
Part A: Healthy Participants 90 mg SC
Healthy participants received 90 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 300 mg SC
Healthy participants received 300 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 900 mg SC
Healthy participants received 900 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 900 mg IV
Healthy Participants received 900 mg VIR-3434 intravenously
|
Part A: Healthy Participants 3000 mg IV
Healthy participants received 3000 mg VIR-3434 intravenously
|
Part A Healthy Participants Placebo
Healthy participants received placebo subcutaneously or intravenously
|
Part B: HBV Participants 6 mg SC
HBV Participants on NRTI therapy with HBsAg \<3000 IU/mL received 6 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 18 mg SC
HBV Participants on NRTI therapy with HBsAg \<3000 IU/mL received 18 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 75 mg SC
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received 75 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 300 mg SC
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received 300 mg VIR-3434 subcutaneous
|
Part B: HBV Participants Placebo
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received placebo subcutaneous
|
Part C: HBV Participants 18 mg SC
HBV Participants on NRTI therapy with HBsAg \>/= 3000 IU/mL received 18 mg VIR-3434 subcutaneous
|
Part C: HBV Participants 75 mg SC
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received 75 mg VIR-3434 subcutaneous
|
Part C: HBV Participants 300 mg SC
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received 300 mg VIR-3434 subcutaneous
|
Part C: HBV Participants Placebo
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received placebo subcutaneous
|
Part D: HBV Participants 75 mg SC
HBV Participants not on NRTI therapy with HBV DNA \>/= 1000 and any HBsAg level received 75 mg VIR-3434 subcutaneous
|
Part D: HBV Participants 300 mg SC
HBV Participants not on NRTI Therapy with HBV DNA \>/= 1000 and any HBsAg level received 300 mg VIR-3434 subcutaneous
|
Part D: HBV Participants Placebo
HBV Participants not on NRTI Therapy with HBV DNA \>/= 1000 IU/mL and any HBsAg level received placebo subcutaneous
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
6
|
11
|
6
|
6
|
6
|
6
|
8
|
6
|
6
|
6
|
6
|
6
|
6
|
4
|
|
Overall Study
Entered Extended Follow Up
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
5
|
5
|
0
|
1
|
0
|
3
|
0
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
6
|
10
|
6
|
6
|
6
|
6
|
8
|
6
|
6
|
4
|
6
|
6
|
6
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part A: Healthy Participants 90 mg SC
Healthy participants received 90 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 300 mg SC
Healthy participants received 300 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 900 mg SC
Healthy participants received 900 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 900 mg IV
Healthy Participants received 900 mg VIR-3434 intravenously
|
Part A: Healthy Participants 3000 mg IV
Healthy participants received 3000 mg VIR-3434 intravenously
|
Part A Healthy Participants Placebo
Healthy participants received placebo subcutaneously or intravenously
|
Part B: HBV Participants 6 mg SC
HBV Participants on NRTI therapy with HBsAg \<3000 IU/mL received 6 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 18 mg SC
HBV Participants on NRTI therapy with HBsAg \<3000 IU/mL received 18 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 75 mg SC
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received 75 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 300 mg SC
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received 300 mg VIR-3434 subcutaneous
|
Part B: HBV Participants Placebo
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received placebo subcutaneous
|
Part C: HBV Participants 18 mg SC
HBV Participants on NRTI therapy with HBsAg \>/= 3000 IU/mL received 18 mg VIR-3434 subcutaneous
|
Part C: HBV Participants 75 mg SC
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received 75 mg VIR-3434 subcutaneous
|
Part C: HBV Participants 300 mg SC
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received 300 mg VIR-3434 subcutaneous
|
Part C: HBV Participants Placebo
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received placebo subcutaneous
|
Part D: HBV Participants 75 mg SC
HBV Participants not on NRTI therapy with HBV DNA \>/= 1000 and any HBsAg level received 75 mg VIR-3434 subcutaneous
|
Part D: HBV Participants 300 mg SC
HBV Participants not on NRTI Therapy with HBV DNA \>/= 1000 and any HBsAg level received 300 mg VIR-3434 subcutaneous
|
Part D: HBV Participants Placebo
HBV Participants not on NRTI Therapy with HBV DNA \>/= 1000 IU/mL and any HBsAg level received placebo subcutaneous
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Sponsor Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
HbsAg levels would not be seen in Healthy Participants, therefore 0 participants were analyzed in Part A.
Baseline characteristics by cohort
| Measure |
Part A: Healthy Participants 90 mg SC
n=6 Participants
Healthy participants received 90 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 300 mg SC
n=6 Participants
Healthy participants received 300 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 900 mg SC
n=6 Participants
Healthy participants received 900 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 900 mg IV
n=6 Participants
Healthy Participants received 900 mg VIR-3434 intravenously
|
Part A: Healthy Participants 3000 mg IV
n=6 Participants
Healthy participants received 3000 mg VIR-3434 intravenously
|
Part A Healthy Participants Placebo
n=11 Participants
Healthy participants received placebo subcutaneously or intravenously
|
Part B: HBV Participants 6 mg SC
n=6 Participants
HBV Participants on NRTI therapy with HBsAg \<3000 IU/mL received 6 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 18 mg SC
n=6 Participants
HBV Participants on NRTI therapy with HBsAg \<3000 IU/mL received 18 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 75 mg SC
n=6 Participants
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received 75 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 300 mg SC
n=6 Participants
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received 300 mg VIR-3434 subcutaneous
|
Part B: HBV Participants Placebo
n=8 Participants
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received placebo subcutaneous
|
Part C: HBV Participants 18 mg SC
n=6 Participants
HBV Participants on NRTI therapy with HBsAg \>/= 3000 IU/mL received 18 mg VIR-3434 subcutaneous
|
Part C: HBV Participants 75 mg SC
n=6 Participants
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received 75 mg VIR-3434 subcutaneous
|
Part C: HBV Participants 300 mg SC
n=6 Participants
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received 300 mg VIR-3434 subcutaneous
|
Part C: HBV Participants Placebo
n=6 Participants
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received placebo subcutaneous
|
Part D: HBV Participants 75 mg SC
n=6 Participants
HBV Participants not on NRTI therapy with HBV DNA \>/= 1000 and any HBsAg level received 75 mg VIR-3434 subcutaneous
|
Part D: HBV Participants 300 mg SC
n=6 Participants
HBV Participants not on NRTI Therapy with HBV DNA \>/= 1000 and any HBsAg level received 300 mg VIR-3434 subcutaneous
|
Part D: HBV Participants Placebo
n=4 Participants
HBV Participants not on NRTI Therapy with HBV DNA \>/= 1000 IU/mL and any HBsAg level received placebo subcutaneous
|
Total
n=113 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
31.3 years
STANDARD_DEVIATION 11.94 • n=6 Participants
|
27.7 years
STANDARD_DEVIATION 7.92 • n=6 Participants
|
31.5 years
STANDARD_DEVIATION 9.77 • n=6 Participants
|
24.8 years
STANDARD_DEVIATION 4.58 • n=6 Participants
|
29.3 years
STANDARD_DEVIATION 12.99 • n=6 Participants
|
30.3 years
STANDARD_DEVIATION 10.77 • n=11 Participants
|
56.3 years
STANDARD_DEVIATION 5.72 • n=6 Participants
|
49.0 years
STANDARD_DEVIATION 6.93 • n=6 Participants
|
50.8 years
STANDARD_DEVIATION 8.35 • n=6 Participants
|
50.0 years
STANDARD_DEVIATION 8.81 • n=6 Participants
|
51.6 years
STANDARD_DEVIATION 6.35 • n=8 Participants
|
44.5 years
STANDARD_DEVIATION 10.82 • n=6 Participants
|
38.2 years
STANDARD_DEVIATION 8.33 • n=6 Participants
|
38.8 years
STANDARD_DEVIATION 8.95 • n=6 Participants
|
44.0 years
STANDARD_DEVIATION 8.53 • n=6 Participants
|
42.7 years
STANDARD_DEVIATION 7.71 • n=6 Participants
|
38.0 years
STANDARD_DEVIATION 6.16 • n=6 Participants
|
37.3 years
STANDARD_DEVIATION 8.54 • n=4 Participants
|
39.6 years
STANDARD_DEVIATION 12.37 • n=113 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
6 Participants
n=11 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
2 Participants
n=4 Participants
|
49 Participants
n=113 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
5 Participants
n=11 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
7 Participants
n=8 Participants
|
3 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
2 Participants
n=4 Participants
|
64 Participants
n=113 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=11 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=113 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
9 Participants
n=11 Participants
|
5 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
4 Participants
n=4 Participants
|
97 Participants
n=113 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=11 Participants
|
1 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
12 Participants
n=113 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=113 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=11 Participants
|
3 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
6 Participants
n=8 Participants
|
5 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
36 Participants
n=113 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=11 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=113 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=113 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
7 Participants
n=11 Participants
|
3 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
2 Participants
n=4 Participants
|
51 Participants
n=113 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=113 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
3 Participants
n=11 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=4 Participants
|
14 Participants
n=113 Participants
|
|
Baseline HbsAg (IU/mL)
|
—
|
—
|
—
|
—
|
—
|
—
|
1.94 log 10 IU/mL
STANDARD_DEVIATION 0.617 • n=6 Participants • HbsAg levels would not be seen in Healthy Participants, therefore 0 participants were analyzed in Part A.
|
2.78 log 10 IU/mL
STANDARD_DEVIATION 0.711 • n=6 Participants • HbsAg levels would not be seen in Healthy Participants, therefore 0 participants were analyzed in Part A.
|
2.55 log 10 IU/mL
STANDARD_DEVIATION 0.693 • n=6 Participants • HbsAg levels would not be seen in Healthy Participants, therefore 0 participants were analyzed in Part A.
|
2.59 log 10 IU/mL
STANDARD_DEVIATION 1.150 • n=6 Participants • HbsAg levels would not be seen in Healthy Participants, therefore 0 participants were analyzed in Part A.
|
2.24 log 10 IU/mL
STANDARD_DEVIATION 0.638 • n=8 Participants • HbsAg levels would not be seen in Healthy Participants, therefore 0 participants were analyzed in Part A.
|
3.34 log 10 IU/mL
STANDARD_DEVIATION 0.455 • n=6 Participants • HbsAg levels would not be seen in Healthy Participants, therefore 0 participants were analyzed in Part A.
|
4.12 log 10 IU/mL
STANDARD_DEVIATION 0.353 • n=6 Participants • HbsAg levels would not be seen in Healthy Participants, therefore 0 participants were analyzed in Part A.
|
3.71 log 10 IU/mL
STANDARD_DEVIATION 0.375 • n=6 Participants • HbsAg levels would not be seen in Healthy Participants, therefore 0 participants were analyzed in Part A.
|
3.18 log 10 IU/mL
STANDARD_DEVIATION 1.652 • n=6 Participants • HbsAg levels would not be seen in Healthy Participants, therefore 0 participants were analyzed in Part A.
|
3.79 log 10 IU/mL
STANDARD_DEVIATION 0.729 • n=6 Participants • HbsAg levels would not be seen in Healthy Participants, therefore 0 participants were analyzed in Part A.
|
4.29 log 10 IU/mL
STANDARD_DEVIATION 0.305 • n=6 Participants • HbsAg levels would not be seen in Healthy Participants, therefore 0 participants were analyzed in Part A.
|
4.15 log 10 IU/mL
STANDARD_DEVIATION 0.496 • n=4 Participants • HbsAg levels would not be seen in Healthy Participants, therefore 0 participants were analyzed in Part A.
|
3.17 log 10 IU/mL
STANDARD_DEVIATION 1.05 • n=72 Participants • HbsAg levels would not be seen in Healthy Participants, therefore 0 participants were analyzed in Part A.
|
PRIMARY outcome
Timeframe: Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/DOutcome measures
| Measure |
Part A: Healthy Participants 90 mg SC
n=6 Participants
Healthy participants received 90 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 300 mg SC
n=6 Participants
Healthy participants received 300 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 900 mg SC
n=6 Participants
Healthy participants received 900 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 900 mg IV
n=6 Participants
Healthy Participants received 900 mg VIR-3434 intravenously
|
Part A: Healthy Participants 3000 mg IV
n=6 Participants
Healthy participants received 3000 mg VIR-3434 intravenously
|
Part A Healthy Participants Placebo
n=11 Participants
Healthy participants received placebo subcutaneously or intravenously
|
Part B: HBV Participants 6 mg SC
n=6 Participants
HBV Participants on NRTI therapy with HBsAg \<3000 IU/mL received 6 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 18 mg SC
n=6 Participants
HBV Participants on NRTI therapy with HBsAg \<3000 IU/mL received 18 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 75 mg SC
n=6 Participants
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received 75 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 300 mg SC
n=6 Participants
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received 300 mg VIR-3434 subcutaneous
|
Part B: HBV Participants Placebo
n=8 Participants
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received placebo subcutaneous
|
Part C: HBV Participants 18 mg SC
n=6 Participants
HBV Participants on NRTI therapy with HBsAg \>/= 3000 IU/mL received 18 mg VIR-3434 subcutaneous
|
Part C: HBV Participants 75 mg SC
n=6 Participants
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received 75 mg VIR-3434 subcutaneous
|
Part C: HBV Participants 300 mg SC
n=6 Participants
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received 300 mg VIR-3434 subcutaneous
|
Part C: HBV Participants Placebo
n=6 Participants
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received placebo subcutaneous
|
Part D: HBV Participants 75 mg SC
n=6 Participants
HBV Participants not on NRTI therapy with HBV DNA \>/= 1000 and any HBsAg level received 75 mg VIR-3434 subcutaneous
|
Part D: HBV Participants 300 mg SC
n=6 Participants
HBV Participants not on NRTI Therapy with HBV DNA \>/= 1000 and any HBsAg level received 300 mg VIR-3434 subcutaneous
|
Part D: HBV Participants Placebo
n=4 Participants
HBV Participants not on NRTI Therapy with HBV DNA \>/= 1000 IU/mL and any HBsAg level received placebo subcutaneous
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
|
5 Participants
|
4 Participants
|
5 Participants
|
4 Participants
|
3 Participants
|
6 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
5 Participants
|
4 Participants
|
2 Participants
|
6 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Up to 280 days post-doseOutcome measures
| Measure |
Part A: Healthy Participants 90 mg SC
n=6 Participants
Healthy participants received 90 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 300 mg SC
n=6 Participants
Healthy participants received 300 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 900 mg SC
n=6 Participants
Healthy participants received 900 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 900 mg IV
n=6 Participants
Healthy Participants received 900 mg VIR-3434 intravenously
|
Part A: Healthy Participants 3000 mg IV
n=6 Participants
Healthy participants received 3000 mg VIR-3434 intravenously
|
Part A Healthy Participants Placebo
n=11 Participants
Healthy participants received placebo subcutaneously or intravenously
|
Part B: HBV Participants 6 mg SC
n=6 Participants
HBV Participants on NRTI therapy with HBsAg \<3000 IU/mL received 6 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 18 mg SC
n=6 Participants
HBV Participants on NRTI therapy with HBsAg \<3000 IU/mL received 18 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 75 mg SC
n=6 Participants
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received 75 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 300 mg SC
n=6 Participants
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received 300 mg VIR-3434 subcutaneous
|
Part B: HBV Participants Placebo
n=8 Participants
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received placebo subcutaneous
|
Part C: HBV Participants 18 mg SC
n=6 Participants
HBV Participants on NRTI therapy with HBsAg \>/= 3000 IU/mL received 18 mg VIR-3434 subcutaneous
|
Part C: HBV Participants 75 mg SC
n=6 Participants
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received 75 mg VIR-3434 subcutaneous
|
Part C: HBV Participants 300 mg SC
n=6 Participants
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received 300 mg VIR-3434 subcutaneous
|
Part C: HBV Participants Placebo
n=6 Participants
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received placebo subcutaneous
|
Part D: HBV Participants 75 mg SC
n=6 Participants
HBV Participants not on NRTI therapy with HBV DNA \>/= 1000 and any HBsAg level received 75 mg VIR-3434 subcutaneous
|
Part D: HBV Participants 300 mg SC
n=6 Participants
HBV Participants not on NRTI Therapy with HBV DNA \>/= 1000 and any HBsAg level received 300 mg VIR-3434 subcutaneous
|
Part D: HBV Participants Placebo
n=4 Participants
HBV Participants not on NRTI Therapy with HBV DNA \>/= 1000 IU/mL and any HBsAg level received placebo subcutaneous
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinical Laboratory Abnormalities
Bilirubin Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
ALT Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
Alkaline phosphatase Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
ALT Grade 1
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
ALT Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
ALT Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
Alkaline phosphatase Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
Alkaline phosphatase Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
Alkaline phosphatase Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
AST Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
AST Grade 2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
AST Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
AST Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
Bilirubin Grade 1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
Bilirubin Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
Bilirubin Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Parts B-D: pre-dose and 1, 4, 6, 24 hours, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dosePopulation: PK Analysis Set
VIR-3434 Maximum Concentration in Serum
Outcome measures
| Measure |
Part A: Healthy Participants 90 mg SC
n=6 Participants
Healthy participants received 90 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 300 mg SC
n=5 Participants
Healthy participants received 300 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 900 mg SC
n=6 Participants
Healthy participants received 900 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 900 mg IV
n=6 Participants
Healthy Participants received 900 mg VIR-3434 intravenously
|
Part A: Healthy Participants 3000 mg IV
n=3 Participants
Healthy participants received 3000 mg VIR-3434 intravenously
|
Part A Healthy Participants Placebo
n=3 Participants
Healthy participants received placebo subcutaneously or intravenously
|
Part B: HBV Participants 6 mg SC
n=6 Participants
HBV Participants on NRTI therapy with HBsAg \<3000 IU/mL received 6 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 18 mg SC
n=4 Participants
HBV Participants on NRTI therapy with HBsAg \<3000 IU/mL received 18 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 75 mg SC
n=5 Participants
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received 75 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 300 mg SC
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received 300 mg VIR-3434 subcutaneous
|
Part B: HBV Participants Placebo
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received placebo subcutaneous
|
Part C: HBV Participants 18 mg SC
HBV Participants on NRTI therapy with HBsAg \>/= 3000 IU/mL received 18 mg VIR-3434 subcutaneous
|
Part C: HBV Participants 75 mg SC
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received 75 mg VIR-3434 subcutaneous
|
Part C: HBV Participants 300 mg SC
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received 300 mg VIR-3434 subcutaneous
|
Part C: HBV Participants Placebo
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received placebo subcutaneous
|
Part D: HBV Participants 75 mg SC
HBV Participants not on NRTI therapy with HBV DNA \>/= 1000 and any HBsAg level received 75 mg VIR-3434 subcutaneous
|
Part D: HBV Participants 300 mg SC
HBV Participants not on NRTI Therapy with HBV DNA \>/= 1000 and any HBsAg level received 300 mg VIR-3434 subcutaneous
|
Part D: HBV Participants Placebo
HBV Participants not on NRTI Therapy with HBV DNA \>/= 1000 IU/mL and any HBsAg level received placebo subcutaneous
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax
|
352 Parts B-D: ng/mL
Geometric Coefficient of Variation 27.0
|
456 Parts B-D: ng/mL
Geometric Coefficient of Variation 152.8
|
5460 Parts B-D: ng/mL
Geometric Coefficient of Variation 36.5
|
19700 Parts B-D: ng/mL
Geometric Coefficient of Variation 56.9
|
835 Parts B-D: ng/mL
Geometric Coefficient of Variation NA
In the 18 mg cohort in Part C, 2 participants among the 3 who had quantifiable PK concentrations only had 2 non-BQL values, so PK parameters were excluded from summary statistics. CV% was only reported when n ≥ 3, so indicated as NA in this case.
|
4750 Parts B-D: ng/mL
Geometric Coefficient of Variation 46.9
|
26100 Parts B-D: ng/mL
Geometric Coefficient of Variation 21.8
|
6000 Parts B-D: ng/mL
Geometric Coefficient of Variation 16.8
|
10800 Parts B-D: ng/mL
Geometric Coefficient of Variation 61.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose; Parts B-D: pre-dose and 1, 4, 6, 24 hours, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dosePopulation: Participants with BQL at all time points were excluded from the PK analysis, hence for different n in the cohorts. CV was only calculated if the PK parameter was estimated in at least 3 subjects
VIR-3434 time of Cmax in Serum
Outcome measures
| Measure |
Part A: Healthy Participants 90 mg SC
n=6 Participants
Healthy participants received 90 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 300 mg SC
n=6 Participants
Healthy participants received 300 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 900 mg SC
n=6 Participants
Healthy participants received 900 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 900 mg IV
n=6 Participants
Healthy Participants received 900 mg VIR-3434 intravenously
|
Part A: Healthy Participants 3000 mg IV
n=6 Participants
Healthy participants received 3000 mg VIR-3434 intravenously
|
Part A Healthy Participants Placebo
n=6 Participants
Healthy participants received placebo subcutaneously or intravenously
|
Part B: HBV Participants 6 mg SC
n=5 Participants
HBV Participants on NRTI therapy with HBsAg \<3000 IU/mL received 6 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 18 mg SC
n=6 Participants
HBV Participants on NRTI therapy with HBsAg \<3000 IU/mL received 18 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 75 mg SC
n=6 Participants
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received 75 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 300 mg SC
n=3 Participants
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received 300 mg VIR-3434 subcutaneous
|
Part B: HBV Participants Placebo
n=3 Participants
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received placebo subcutaneous
|
Part C: HBV Participants 18 mg SC
n=6 Participants
HBV Participants on NRTI therapy with HBsAg \>/= 3000 IU/mL received 18 mg VIR-3434 subcutaneous
|
Part C: HBV Participants 75 mg SC
n=4 Participants
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received 75 mg VIR-3434 subcutaneous
|
Part C: HBV Participants 300 mg SC
n=5 Participants
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received 300 mg VIR-3434 subcutaneous
|
Part C: HBV Participants Placebo
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received placebo subcutaneous
|
Part D: HBV Participants 75 mg SC
HBV Participants not on NRTI therapy with HBV DNA \>/= 1000 and any HBsAg level received 75 mg VIR-3434 subcutaneous
|
Part D: HBV Participants 300 mg SC
HBV Participants not on NRTI Therapy with HBV DNA \>/= 1000 and any HBsAg level received 300 mg VIR-3434 subcutaneous
|
Part D: HBV Participants Placebo
HBV Participants not on NRTI Therapy with HBV DNA \>/= 1000 IU/mL and any HBsAg level received placebo subcutaneous
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tmax
|
7.00 day
Interval 3.0 to 7.01
|
7 day
Interval 3.0 to 7.0
|
3 day
Interval 3.0 to 7.0
|
.0833 day
Interval 0.0417 to 0.292
|
.0833 day
Interval 0.0417 to 0.0847
|
6.90 day
Interval 1.01 to 7.0
|
2.92 day
Interval 1.0 to 6.88
|
5.44 day
Interval 2.83 to 7.03
|
2.96 day
Interval 2.11 to 6.97
|
3.98 day
Interval 3.98 to 3.98
|
3.00 day
Interval 2.95 to 3.94
|
2.99 day
Interval 2.86 to 6.97
|
4.08 day
Interval 0.0417 to 8.11
|
2.99 day
Interval 2.91 to 3.15
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Parts B-D: pre-dose and 1, 4, 6, 24 hours, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dosePopulation: Participants with BQL at all time points were excluded from the PK analysis, hence for different n in the cohorts.
VIR-3434 under the curve from time 0 to last measurable Time
Outcome measures
| Measure |
Part A: Healthy Participants 90 mg SC
n=6 Participants
Healthy participants received 90 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 300 mg SC
n=5 Participants
Healthy participants received 300 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 900 mg SC
n=6 Participants
Healthy participants received 900 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 900 mg IV
n=6 Participants
Healthy Participants received 900 mg VIR-3434 intravenously
|
Part A: Healthy Participants 3000 mg IV
n=3 Participants
Healthy participants received 3000 mg VIR-3434 intravenously
|
Part A Healthy Participants Placebo
n=3 Participants
Healthy participants received placebo subcutaneously or intravenously
|
Part B: HBV Participants 6 mg SC
n=6 Participants
HBV Participants on NRTI therapy with HBsAg \<3000 IU/mL received 6 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 18 mg SC
n=4 Participants
HBV Participants on NRTI therapy with HBsAg \<3000 IU/mL received 18 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 75 mg SC
n=5 Participants
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received 75 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 300 mg SC
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received 300 mg VIR-3434 subcutaneous
|
Part B: HBV Participants Placebo
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received placebo subcutaneous
|
Part C: HBV Participants 18 mg SC
HBV Participants on NRTI therapy with HBsAg \>/= 3000 IU/mL received 18 mg VIR-3434 subcutaneous
|
Part C: HBV Participants 75 mg SC
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received 75 mg VIR-3434 subcutaneous
|
Part C: HBV Participants 300 mg SC
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received 300 mg VIR-3434 subcutaneous
|
Part C: HBV Participants Placebo
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received placebo subcutaneous
|
Part D: HBV Participants 75 mg SC
HBV Participants not on NRTI therapy with HBV DNA \>/= 1000 and any HBsAg level received 75 mg VIR-3434 subcutaneous
|
Part D: HBV Participants 300 mg SC
HBV Participants not on NRTI Therapy with HBV DNA \>/= 1000 and any HBsAg level received 300 mg VIR-3434 subcutaneous
|
Part D: HBV Participants Placebo
HBV Participants not on NRTI Therapy with HBV DNA \>/= 1000 IU/mL and any HBsAg level received placebo subcutaneous
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUClast
|
3130 Parts B-D: day*ng/mL
Geometric Coefficient of Variation 67.5
|
4150 Parts B-D: day*ng/mL
Geometric Coefficient of Variation 270.0
|
106000 Parts B-D: day*ng/mL
Geometric Coefficient of Variation 72.3
|
381000 Parts B-D: day*ng/mL
Geometric Coefficient of Variation 94.2
|
9540 Parts B-D: day*ng/mL
Geometric Coefficient of Variation NA
In the 18 mg cohort in Part C, 2 participants among the 3 who had quantifiable PK concentrations only had 2 non-BQL values, so PK parameters were excluded from summary statistics. CV% was only reported when n ≥ 3, so indicated as NA in this case.
|
39000 Parts B-D: day*ng/mL
Geometric Coefficient of Variation 133.0
|
181,000 Parts B-D: day*ng/mL
Geometric Coefficient of Variation 964.4
|
9,270 Parts B-D: day*ng/mL
Geometric Coefficient of Variation 1,139.9
|
54,300 Parts B-D: day*ng/mL
Geometric Coefficient of Variation 122.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose; Parts B-D: pre-dose and 1, 4, 6, 24 hours, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dosePopulation: PK Anal;ysis Set
VIR-3434 apparent Elimination Half-life (t1/2) in serum
Outcome measures
| Measure |
Part A: Healthy Participants 90 mg SC
n=6 Participants
Healthy participants received 90 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 300 mg SC
n=6 Participants
Healthy participants received 300 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 900 mg SC
n=6 Participants
Healthy participants received 900 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 900 mg IV
n=6 Participants
Healthy Participants received 900 mg VIR-3434 intravenously
|
Part A: Healthy Participants 3000 mg IV
n=6 Participants
Healthy participants received 3000 mg VIR-3434 intravenously
|
Part A Healthy Participants Placebo
n=6 Participants
Healthy participants received placebo subcutaneously or intravenously
|
Part B: HBV Participants 6 mg SC
n=5 Participants
HBV Participants on NRTI therapy with HBsAg \<3000 IU/mL received 6 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 18 mg SC
n=6 Participants
HBV Participants on NRTI therapy with HBsAg \<3000 IU/mL received 18 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 75 mg SC
n=6 Participants
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received 75 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 300 mg SC
n=3 Participants
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received 300 mg VIR-3434 subcutaneous
|
Part B: HBV Participants Placebo
n=3 Participants
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received placebo subcutaneous
|
Part C: HBV Participants 18 mg SC
n=6 Participants
HBV Participants on NRTI therapy with HBsAg \>/= 3000 IU/mL received 18 mg VIR-3434 subcutaneous
|
Part C: HBV Participants 75 mg SC
n=4 Participants
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received 75 mg VIR-3434 subcutaneous
|
Part C: HBV Participants 300 mg SC
n=5 Participants
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received 300 mg VIR-3434 subcutaneous
|
Part C: HBV Participants Placebo
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received placebo subcutaneous
|
Part D: HBV Participants 75 mg SC
HBV Participants not on NRTI therapy with HBV DNA \>/= 1000 and any HBsAg level received 75 mg VIR-3434 subcutaneous
|
Part D: HBV Participants 300 mg SC
HBV Participants not on NRTI Therapy with HBV DNA \>/= 1000 and any HBsAg level received 300 mg VIR-3434 subcutaneous
|
Part D: HBV Participants Placebo
HBV Participants not on NRTI Therapy with HBV DNA \>/= 1000 IU/mL and any HBsAg level received placebo subcutaneous
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
t1/2
|
28.5 day
Interval 27.0 to 30.3
|
24.3 day
Interval 23.2 to 26.6
|
25.2 day
Interval 21.6 to 28.7
|
24.0 day
Interval 20.7 to 25.7
|
20.7 day
Interval 19.3 to 22.7
|
3.57 day
Interval 2.33 to 4.81
|
6.34 day
Interval 6.34 to 6.34
|
7.94 day
Interval 3.54 to 17.2
|
13.6 day
Interval 5.96 to 16.0
|
3.82 day
Interval 3.82 to 3.82
|
4.25 day
Interval 2.48 to 6.02
|
8.36 day
Interval 4.16 to 11.8
|
3.17 day
Interval 3.17 to 3.17
|
1.99 day
Interval 1.99 to 1.99
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose; Parts B-D: pre-dose and 1, 4, 6, 24 hours, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dosePopulation: PK Analysis Set
VIR-3434 Volume of Distribution (SC only)
Outcome measures
| Measure |
Part A: Healthy Participants 90 mg SC
n=6 Participants
Healthy participants received 90 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 300 mg SC
n=6 Participants
Healthy participants received 300 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 900 mg SC
n=6 Participants
Healthy participants received 900 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 900 mg IV
n=6 Participants
Healthy Participants received 900 mg VIR-3434 intravenously
|
Part A: Healthy Participants 3000 mg IV
n=5 Participants
Healthy participants received 3000 mg VIR-3434 intravenously
|
Part A Healthy Participants Placebo
n=6 Participants
Healthy participants received placebo subcutaneously or intravenously
|
Part B: HBV Participants 6 mg SC
n=6 Participants
HBV Participants on NRTI therapy with HBsAg \<3000 IU/mL received 6 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 18 mg SC
n=3 Participants
HBV Participants on NRTI therapy with HBsAg \<3000 IU/mL received 18 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 75 mg SC
n=3 Participants
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received 75 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 300 mg SC
n=6 Participants
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received 300 mg VIR-3434 subcutaneous
|
Part B: HBV Participants Placebo
n=4 Participants
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received placebo subcutaneous
|
Part C: HBV Participants 18 mg SC
n=5 Participants
HBV Participants on NRTI therapy with HBsAg \>/= 3000 IU/mL received 18 mg VIR-3434 subcutaneous
|
Part C: HBV Participants 75 mg SC
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received 75 mg VIR-3434 subcutaneous
|
Part C: HBV Participants 300 mg SC
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received 300 mg VIR-3434 subcutaneous
|
Part C: HBV Participants Placebo
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received placebo subcutaneous
|
Part D: HBV Participants 75 mg SC
HBV Participants not on NRTI therapy with HBV DNA \>/= 1000 and any HBsAg level received 75 mg VIR-3434 subcutaneous
|
Part D: HBV Participants 300 mg SC
HBV Participants not on NRTI Therapy with HBV DNA \>/= 1000 and any HBsAg level received 300 mg VIR-3434 subcutaneous
|
Part D: HBV Participants Placebo
HBV Participants not on NRTI Therapy with HBV DNA \>/= 1000 IU/mL and any HBsAg level received placebo subcutaneous
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Vz/F
|
12200 mL
Geometric Coefficient of Variation 15.2
|
10900 mL
Geometric Coefficient of Variation 27.3
|
10600 mL
Geometric Coefficient of Variation 27.7
|
9420 mL
Geometric Coefficient of Variation 12.9
|
4540 mL
Geometric Coefficient of Variation NA
the SAP specified that if span of \< 2 half-lives or (adjusted) r2 \< 0.80 or %AUCexp \>20%, all elimination related parameters including Vz/F and CL/F were excluded from summary statistics. And since n\<3, %CV was NA.
|
7410 mL
Geometric Coefficient of Variation 21.5
|
9830 mL
Geometric Coefficient of Variation 54.2
|
10300 mL
Geometric Coefficient of Variation NA
the SAP specified that if span of \< 2 half-lives or (adjusted) r2 \< 0.80 or %AUCexp \>20%, all elimination related parameters including Vz/F and CL/F were excluded from summary statistics. And since n\<3, %CV was NA.
|
6710 mL
Geometric Coefficient of Variation 27.4
|
7330 mL
Geometric Coefficient of Variation 22.5
|
5000 mL
Geometric Coefficient of Variation NA
the SAP specified that if span of \< 2 half-lives or (adjusted) r2 \< 0.80 or %AUCexp \>20%, all elimination related parameters including Vz/F and CL/F were excluded from summary statistics. And since n\<3, %CV was NA.
|
4880 mL
Geometric Coefficient of Variation NA
the SAP specified that if span of \< 2 half-lives or (adjusted) r2 \< 0.80 or %AUCexp \>20%, all elimination related parameters including Vz/F and CL/F were excluded from summary statistics. And since n\<3, %CV was NA.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-doseVIR-3434 Volume of Distribution (IV only)
Outcome measures
| Measure |
Part A: Healthy Participants 90 mg SC
n=6 Participants
Healthy participants received 90 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 300 mg SC
n=6 Participants
Healthy participants received 300 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 900 mg SC
Healthy participants received 900 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 900 mg IV
Healthy Participants received 900 mg VIR-3434 intravenously
|
Part A: Healthy Participants 3000 mg IV
Healthy participants received 3000 mg VIR-3434 intravenously
|
Part A Healthy Participants Placebo
Healthy participants received placebo subcutaneously or intravenously
|
Part B: HBV Participants 6 mg SC
HBV Participants on NRTI therapy with HBsAg \<3000 IU/mL received 6 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 18 mg SC
HBV Participants on NRTI therapy with HBsAg \<3000 IU/mL received 18 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 75 mg SC
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received 75 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 300 mg SC
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received 300 mg VIR-3434 subcutaneous
|
Part B: HBV Participants Placebo
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received placebo subcutaneous
|
Part C: HBV Participants 18 mg SC
HBV Participants on NRTI therapy with HBsAg \>/= 3000 IU/mL received 18 mg VIR-3434 subcutaneous
|
Part C: HBV Participants 75 mg SC
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received 75 mg VIR-3434 subcutaneous
|
Part C: HBV Participants 300 mg SC
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received 300 mg VIR-3434 subcutaneous
|
Part C: HBV Participants Placebo
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received placebo subcutaneous
|
Part D: HBV Participants 75 mg SC
HBV Participants not on NRTI therapy with HBV DNA \>/= 1000 and any HBsAg level received 75 mg VIR-3434 subcutaneous
|
Part D: HBV Participants 300 mg SC
HBV Participants not on NRTI Therapy with HBV DNA \>/= 1000 and any HBsAg level received 300 mg VIR-3434 subcutaneous
|
Part D: HBV Participants Placebo
HBV Participants not on NRTI Therapy with HBV DNA \>/= 1000 IU/mL and any HBsAg level received placebo subcutaneous
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Vz
|
7620 mL
Geometric Coefficient of Variation 26.3
|
7290 mL
Geometric Coefficient of Variation 24.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose; Parts B-D: pre-dose and 1, 4, 6, 24 hours, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dosePopulation: PK Analysis Set
VIR-3434 Apparent serum clearance (SC only)
Outcome measures
| Measure |
Part A: Healthy Participants 90 mg SC
n=6 Participants
Healthy participants received 90 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 300 mg SC
n=6 Participants
Healthy participants received 300 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 900 mg SC
n=6 Participants
Healthy participants received 900 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 900 mg IV
n=6 Participants
Healthy Participants received 900 mg VIR-3434 intravenously
|
Part A: Healthy Participants 3000 mg IV
n=5 Participants
Healthy participants received 3000 mg VIR-3434 intravenously
|
Part A Healthy Participants Placebo
n=6 Participants
Healthy participants received placebo subcutaneously or intravenously
|
Part B: HBV Participants 6 mg SC
n=6 Participants
HBV Participants on NRTI therapy with HBsAg \<3000 IU/mL received 6 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 18 mg SC
n=3 Participants
HBV Participants on NRTI therapy with HBsAg \<3000 IU/mL received 18 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 75 mg SC
n=3 Participants
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received 75 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 300 mg SC
n=6 Participants
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received 300 mg VIR-3434 subcutaneous
|
Part B: HBV Participants Placebo
n=4 Participants
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received placebo subcutaneous
|
Part C: HBV Participants 18 mg SC
n=5 Participants
HBV Participants on NRTI therapy with HBsAg \>/= 3000 IU/mL received 18 mg VIR-3434 subcutaneous
|
Part C: HBV Participants 75 mg SC
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received 75 mg VIR-3434 subcutaneous
|
Part C: HBV Participants 300 mg SC
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received 300 mg VIR-3434 subcutaneous
|
Part C: HBV Participants Placebo
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received placebo subcutaneous
|
Part D: HBV Participants 75 mg SC
HBV Participants not on NRTI therapy with HBV DNA \>/= 1000 and any HBsAg level received 75 mg VIR-3434 subcutaneous
|
Part D: HBV Participants 300 mg SC
HBV Participants not on NRTI Therapy with HBV DNA \>/= 1000 and any HBsAg level received 300 mg VIR-3434 subcutaneous
|
Part D: HBV Participants Placebo
HBV Participants not on NRTI Therapy with HBV DNA \>/= 1000 IU/mL and any HBsAg level received placebo subcutaneous
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
CL/F
|
295 mL/day
Geometric Coefficient of Variation 16.0
|
308 mL/day
Geometric Coefficient of Variation 22.7
|
292 mL/day
Geometric Coefficient of Variation 19.7
|
1950 mL/day
Geometric Coefficient of Variation 71.2
|
496 mL/day
Geometric Coefficient of Variation NA
The SAP specified that if span of \< 2 half-lives or (adjusted) r2 \< 0.80 or %AUCexp \>20%, all elimination related parameters including Vz/F and CL/F were excluded from summary statistics. And since n\<3, %CV was NA.
|
697 mL/day
Geometric Coefficient of Variation 71.6
|
653 mL/day
Geometric Coefficient of Variation 85.6
|
1860 mL/day
Geometric Coefficient of Variation NA
The SAP specified that if span of \< 2 half-lives or (adjusted) r2 \< 0.80 or %AUCexp \>20%, all elimination related parameters including Vz/F and CL/F were excluded from summary statistics. And since n\<3, %CV was NA.
|
1200 mL/day
Geometric Coefficient of Variation 111.2
|
670 mL/day
Geometric Coefficient of Variation 32.8
|
1090 mL/day
Geometric Coefficient of Variation NA
The SAP specified that if span of \< 2 half-lives or (adjusted) r2 \< 0.80 or %AUCexp \>20%, all elimination related parameters including Vz/F and CL/F were excluded from summary statistics. And since n\<3, %CV was NA.
|
1700 mL/day
Geometric Coefficient of Variation NA
The SAP specified that if span of \< 2 half-lives or (adjusted) r2 \< 0.80 or %AUCexp \>20%, all elimination related parameters including Vz/F and CL/F were excluded from summary statistics. And since n\<3, %CV was NA.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-doseVIR-3434 Apparent serum clearance (IV only)
Outcome measures
| Measure |
Part A: Healthy Participants 90 mg SC
n=6 Participants
Healthy participants received 90 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 300 mg SC
n=6 Participants
Healthy participants received 300 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 900 mg SC
Healthy participants received 900 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 900 mg IV
Healthy Participants received 900 mg VIR-3434 intravenously
|
Part A: Healthy Participants 3000 mg IV
Healthy participants received 3000 mg VIR-3434 intravenously
|
Part A Healthy Participants Placebo
Healthy participants received placebo subcutaneously or intravenously
|
Part B: HBV Participants 6 mg SC
HBV Participants on NRTI therapy with HBsAg \<3000 IU/mL received 6 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 18 mg SC
HBV Participants on NRTI therapy with HBsAg \<3000 IU/mL received 18 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 75 mg SC
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received 75 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 300 mg SC
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received 300 mg VIR-3434 subcutaneous
|
Part B: HBV Participants Placebo
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received placebo subcutaneous
|
Part C: HBV Participants 18 mg SC
HBV Participants on NRTI therapy with HBsAg \>/= 3000 IU/mL received 18 mg VIR-3434 subcutaneous
|
Part C: HBV Participants 75 mg SC
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received 75 mg VIR-3434 subcutaneous
|
Part C: HBV Participants 300 mg SC
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received 300 mg VIR-3434 subcutaneous
|
Part C: HBV Participants Placebo
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received placebo subcutaneous
|
Part D: HBV Participants 75 mg SC
HBV Participants not on NRTI therapy with HBV DNA \>/= 1000 and any HBsAg level received 75 mg VIR-3434 subcutaneous
|
Part D: HBV Participants 300 mg SC
HBV Participants not on NRTI Therapy with HBV DNA \>/= 1000 and any HBsAg level received 300 mg VIR-3434 subcutaneous
|
Part D: HBV Participants Placebo
HBV Participants not on NRTI Therapy with HBV DNA \>/= 1000 IU/mL and any HBsAg level received placebo subcutaneous
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
CL
|
244 mL/day
Geometric Coefficient of Variation 19.6
|
1950 mL/day
Geometric Coefficient of Variation 71.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part A: Up to 168 days post-dose. Parts B-D: Up to 280 days post-dosePopulation: Immunogenicity Analysis Set
Evaluate the immunogenicity of VIR-3434
Outcome measures
| Measure |
Part A: Healthy Participants 90 mg SC
n=6 Participants
Healthy participants received 90 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 300 mg SC
n=6 Participants
Healthy participants received 300 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 900 mg SC
n=6 Participants
Healthy participants received 900 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 900 mg IV
n=6 Participants
Healthy Participants received 900 mg VIR-3434 intravenously
|
Part A: Healthy Participants 3000 mg IV
n=6 Participants
Healthy participants received 3000 mg VIR-3434 intravenously
|
Part A Healthy Participants Placebo
n=6 Participants
Healthy participants received placebo subcutaneously or intravenously
|
Part B: HBV Participants 6 mg SC
n=6 Participants
HBV Participants on NRTI therapy with HBsAg \<3000 IU/mL received 6 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 18 mg SC
n=6 Participants
HBV Participants on NRTI therapy with HBsAg \<3000 IU/mL received 18 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 75 mg SC
n=6 Participants
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received 75 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 300 mg SC
n=6 Participants
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received 300 mg VIR-3434 subcutaneous
|
Part B: HBV Participants Placebo
n=6 Participants
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received placebo subcutaneous
|
Part C: HBV Participants 18 mg SC
n=6 Participants
HBV Participants on NRTI therapy with HBsAg \>/= 3000 IU/mL received 18 mg VIR-3434 subcutaneous
|
Part C: HBV Participants 75 mg SC
n=6 Participants
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received 75 mg VIR-3434 subcutaneous
|
Part C: HBV Participants 300 mg SC
n=6 Participants
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received 300 mg VIR-3434 subcutaneous
|
Part C: HBV Participants Placebo
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received placebo subcutaneous
|
Part D: HBV Participants 75 mg SC
HBV Participants not on NRTI therapy with HBV DNA \>/= 1000 and any HBsAg level received 75 mg VIR-3434 subcutaneous
|
Part D: HBV Participants 300 mg SC
HBV Participants not on NRTI Therapy with HBV DNA \>/= 1000 and any HBsAg level received 300 mg VIR-3434 subcutaneous
|
Part D: HBV Participants Placebo
HBV Participants not on NRTI Therapy with HBV DNA \>/= 1000 IU/mL and any HBsAg level received placebo subcutaneous
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With ADA to VIR-3434
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Parts B-D: pre-dose and 1, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-doseHBsAg reductions at nadir and Week 4
Outcome measures
| Measure |
Part A: Healthy Participants 90 mg SC
n=6 Participants
Healthy participants received 90 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 300 mg SC
n=6 Participants
Healthy participants received 300 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 900 mg SC
n=6 Participants
Healthy participants received 900 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 900 mg IV
n=6 Participants
Healthy Participants received 900 mg VIR-3434 intravenously
|
Part A: Healthy Participants 3000 mg IV
n=8 Participants
Healthy participants received 3000 mg VIR-3434 intravenously
|
Part A Healthy Participants Placebo
n=6 Participants
Healthy participants received placebo subcutaneously or intravenously
|
Part B: HBV Participants 6 mg SC
n=6 Participants
HBV Participants on NRTI therapy with HBsAg \<3000 IU/mL received 6 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 18 mg SC
n=6 Participants
HBV Participants on NRTI therapy with HBsAg \<3000 IU/mL received 18 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 75 mg SC
n=6 Participants
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received 75 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 300 mg SC
n=6 Participants
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received 300 mg VIR-3434 subcutaneous
|
Part B: HBV Participants Placebo
n=6 Participants
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received placebo subcutaneous
|
Part C: HBV Participants 18 mg SC
n=4 Participants
HBV Participants on NRTI therapy with HBsAg \>/= 3000 IU/mL received 18 mg VIR-3434 subcutaneous
|
Part C: HBV Participants 75 mg SC
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received 75 mg VIR-3434 subcutaneous
|
Part C: HBV Participants 300 mg SC
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received 300 mg VIR-3434 subcutaneous
|
Part C: HBV Participants Placebo
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received placebo subcutaneous
|
Part D: HBV Participants 75 mg SC
HBV Participants not on NRTI therapy with HBV DNA \>/= 1000 and any HBsAg level received 75 mg VIR-3434 subcutaneous
|
Part D: HBV Participants 300 mg SC
HBV Participants not on NRTI Therapy with HBV DNA \>/= 1000 and any HBsAg level received 300 mg VIR-3434 subcutaneous
|
Part D: HBV Participants Placebo
HBV Participants not on NRTI Therapy with HBV DNA \>/= 1000 IU/mL and any HBsAg level received placebo subcutaneous
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Reduction of Serum HBsAg From Baseline (Day 1 Predose)
Nadir
|
-1.30 IU/mL
Standard Deviation 0.152
|
-1.27 IU/mL
Standard Deviation 0.666
|
-1.96 IU/mL
Standard Deviation 0.436
|
-2.24 IU/mL
Standard Deviation 0.353
|
-0.04 IU/mL
Standard Deviation 0.039
|
-1.05 IU/mL
Standard Deviation 0.598
|
-1.28 IU/mL
Standard Deviation 0.749
|
-2.17 IU/mL
Standard Deviation 0.252
|
-0.06 IU/mL
Standard Deviation 0.092
|
-1.77 IU/mL
Standard Deviation 0.931
|
-1.83 IU/mL
Standard Deviation 0.219
|
-0.09 IU/mL
Standard Deviation 0.039
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Reduction of Serum HBsAg From Baseline (Day 1 Predose)
Week 4
|
-0.61 IU/mL
Standard Deviation 0.400
|
-0.38 IU/mL
Standard Deviation 0.503
|
-1.51 IU/mL
Standard Deviation 0.245
|
-1.69 IU/mL
Standard Deviation 0.766
|
0.02 IU/mL
Standard Deviation 0.039
|
-0.30 IU/mL
Standard Deviation 0.382
|
-0.16 IU/mL
Standard Deviation 0.175
|
-1.43 IU/mL
Standard Deviation 0.711
|
-0.01 IU/mL
Standard Deviation 0.129
|
-0.48 IU/mL
Standard Deviation 0.608
|
-0.37 IU/mL
Standard Deviation 0.368
|
-0.00 IU/mL
Standard Deviation 0.016
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Parts B-D: pre-dose and 1, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose Parts B-D: pre-dose and 1, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-doseHBV DNA reductions at nadir and Week 4
Outcome measures
| Measure |
Part A: Healthy Participants 90 mg SC
n=6 Participants
Healthy participants received 90 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 300 mg SC
n=6 Participants
Healthy participants received 300 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 900 mg SC
n=4 Participants
Healthy participants received 900 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 900 mg IV
Healthy Participants received 900 mg VIR-3434 intravenously
|
Part A: Healthy Participants 3000 mg IV
Healthy participants received 3000 mg VIR-3434 intravenously
|
Part A Healthy Participants Placebo
Healthy participants received placebo subcutaneously or intravenously
|
Part B: HBV Participants 6 mg SC
HBV Participants on NRTI therapy with HBsAg \<3000 IU/mL received 6 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 18 mg SC
HBV Participants on NRTI therapy with HBsAg \<3000 IU/mL received 18 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 75 mg SC
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received 75 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 300 mg SC
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received 300 mg VIR-3434 subcutaneous
|
Part B: HBV Participants Placebo
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received placebo subcutaneous
|
Part C: HBV Participants 18 mg SC
HBV Participants on NRTI therapy with HBsAg \>/= 3000 IU/mL received 18 mg VIR-3434 subcutaneous
|
Part C: HBV Participants 75 mg SC
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received 75 mg VIR-3434 subcutaneous
|
Part C: HBV Participants 300 mg SC
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received 300 mg VIR-3434 subcutaneous
|
Part C: HBV Participants Placebo
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received placebo subcutaneous
|
Part D: HBV Participants 75 mg SC
HBV Participants not on NRTI therapy with HBV DNA \>/= 1000 and any HBsAg level received 75 mg VIR-3434 subcutaneous
|
Part D: HBV Participants 300 mg SC
HBV Participants not on NRTI Therapy with HBV DNA \>/= 1000 and any HBsAg level received 300 mg VIR-3434 subcutaneous
|
Part D: HBV Participants Placebo
HBV Participants not on NRTI Therapy with HBV DNA \>/= 1000 IU/mL and any HBsAg level received placebo subcutaneous
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part D Only: Maximum Change of HBV DNA From Baseline (Day 1 Predose)
Nadir
|
-1.44 IU/mL
Standard Deviation 0.998
|
-2.07 IU/mL
Standard Deviation 1.007
|
-0.12 IU/mL
Standard Deviation 0.06
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part D Only: Maximum Change of HBV DNA From Baseline (Day 1 Predose)
Week 4
|
-0.70 IU/mL
Standard Deviation 0.917
|
-0.61 IU/mL
Standard Deviation 1.195
|
0.06 IU/mL
Standard Deviation 0.472
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part A: Up to 168 days post-dose. Parts B-D: Up to 280 days post-dosePopulation: Immunogenicity Analysis Set
Evaluate the immunogenicity of VIR-3434
Outcome measures
| Measure |
Part A: Healthy Participants 90 mg SC
n=6 Participants
Healthy participants received 90 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 300 mg SC
n=6 Participants
Healthy participants received 300 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 900 mg SC
n=6 Participants
Healthy participants received 900 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 900 mg IV
n=6 Participants
Healthy Participants received 900 mg VIR-3434 intravenously
|
Part A: Healthy Participants 3000 mg IV
n=6 Participants
Healthy participants received 3000 mg VIR-3434 intravenously
|
Part A Healthy Participants Placebo
n=6 Participants
Healthy participants received placebo subcutaneously or intravenously
|
Part B: HBV Participants 6 mg SC
n=6 Participants
HBV Participants on NRTI therapy with HBsAg \<3000 IU/mL received 6 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 18 mg SC
n=6 Participants
HBV Participants on NRTI therapy with HBsAg \<3000 IU/mL received 18 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 75 mg SC
n=6 Participants
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received 75 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 300 mg SC
n=6 Participants
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received 300 mg VIR-3434 subcutaneous
|
Part B: HBV Participants Placebo
n=6 Participants
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received placebo subcutaneous
|
Part C: HBV Participants 18 mg SC
n=6 Participants
HBV Participants on NRTI therapy with HBsAg \>/= 3000 IU/mL received 18 mg VIR-3434 subcutaneous
|
Part C: HBV Participants 75 mg SC
n=6 Participants
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received 75 mg VIR-3434 subcutaneous
|
Part C: HBV Participants 300 mg SC
n=6 Participants
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received 300 mg VIR-3434 subcutaneous
|
Part C: HBV Participants Placebo
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received placebo subcutaneous
|
Part D: HBV Participants 75 mg SC
HBV Participants not on NRTI therapy with HBV DNA \>/= 1000 and any HBsAg level received 75 mg VIR-3434 subcutaneous
|
Part D: HBV Participants 300 mg SC
HBV Participants not on NRTI Therapy with HBV DNA \>/= 1000 and any HBsAg level received 300 mg VIR-3434 subcutaneous
|
Part D: HBV Participants Placebo
HBV Participants not on NRTI Therapy with HBV DNA \>/= 1000 IU/mL and any HBsAg level received placebo subcutaneous
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Titers (if Applicable) of ADA to VIR-3434
|
0 Median Titer
Interval 0.0 to 0.0
|
20 Median Titer
Interval 20.0 to 40.0
|
160 Median Titer
Interval 160.0 to 160.0
|
0 Median Titer
Interval 0.0 to 0.0
|
0 Median Titer
Interval 0.0 to 0.0
|
0 Median Titer
Interval 0.0 to 0.0
|
40 Median Titer
Interval 40.0 to 40.0
|
80 Median Titer
Interval 40.0 to 160.0
|
240 Median Titer
Interval 20.0 to 1280.0
|
120 Median Titer
Interval 80.0 to 160.0
|
80 Median Titer
Interval 80.0 to 80.0
|
20 Median Titer
Interval 19.0 to 40.0
|
40 Median Titer
Interval 20.0 to 2560.0
|
20 Median Titer
Interval 20.0 to 320.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dosePopulation: PK Analysis Set
VIR-3434 Maximum Concentration in Serum
Outcome measures
| Measure |
Part A: Healthy Participants 90 mg SC
n=6 Participants
Healthy participants received 90 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 300 mg SC
n=6 Participants
Healthy participants received 300 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 900 mg SC
n=6 Participants
Healthy participants received 900 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 900 mg IV
n=6 Participants
Healthy Participants received 900 mg VIR-3434 intravenously
|
Part A: Healthy Participants 3000 mg IV
n=6 Participants
Healthy participants received 3000 mg VIR-3434 intravenously
|
Part A Healthy Participants Placebo
Healthy participants received placebo subcutaneously or intravenously
|
Part B: HBV Participants 6 mg SC
HBV Participants on NRTI therapy with HBsAg \<3000 IU/mL received 6 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 18 mg SC
HBV Participants on NRTI therapy with HBsAg \<3000 IU/mL received 18 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 75 mg SC
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received 75 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 300 mg SC
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received 300 mg VIR-3434 subcutaneous
|
Part B: HBV Participants Placebo
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received placebo subcutaneous
|
Part C: HBV Participants 18 mg SC
HBV Participants on NRTI therapy with HBsAg \>/= 3000 IU/mL received 18 mg VIR-3434 subcutaneous
|
Part C: HBV Participants 75 mg SC
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received 75 mg VIR-3434 subcutaneous
|
Part C: HBV Participants 300 mg SC
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received 300 mg VIR-3434 subcutaneous
|
Part C: HBV Participants Placebo
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received placebo subcutaneous
|
Part D: HBV Participants 75 mg SC
HBV Participants not on NRTI therapy with HBV DNA \>/= 1000 and any HBsAg level received 75 mg VIR-3434 subcutaneous
|
Part D: HBV Participants 300 mg SC
HBV Participants not on NRTI Therapy with HBV DNA \>/= 1000 and any HBsAg level received 300 mg VIR-3434 subcutaneous
|
Part D: HBV Participants Placebo
HBV Participants not on NRTI Therapy with HBV DNA \>/= 1000 IU/mL and any HBsAg level received placebo subcutaneous
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax
|
9.46 Part A: μg/mL
Geometric Coefficient of Variation 27.4
|
32.1 Part A: μg/mL
Geometric Coefficient of Variation 18.0
|
105 Part A: μg/mL
Geometric Coefficient of Variation 23.7
|
363 Part A: μg/mL
Geometric Coefficient of Variation 32.6
|
1060 Part A: μg/mL
Geometric Coefficient of Variation 20.00
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dosePopulation: Participants with BQL at all time points were excluded from the PK analysis, hence for different n in the cohorts. AUClast was only calculated if the PK parameter was estimated in at least 3 subjects
VIR-3434 under the curve from time 0 to last measurable Time
Outcome measures
| Measure |
Part A: Healthy Participants 90 mg SC
n=6 Participants
Healthy participants received 90 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 300 mg SC
n=6 Participants
Healthy participants received 300 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 900 mg SC
n=6 Participants
Healthy participants received 900 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 900 mg IV
n=6 Participants
Healthy Participants received 900 mg VIR-3434 intravenously
|
Part A: Healthy Participants 3000 mg IV
n=6 Participants
Healthy participants received 3000 mg VIR-3434 intravenously
|
Part A Healthy Participants Placebo
Healthy participants received placebo subcutaneously or intravenously
|
Part B: HBV Participants 6 mg SC
HBV Participants on NRTI therapy with HBsAg \<3000 IU/mL received 6 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 18 mg SC
HBV Participants on NRTI therapy with HBsAg \<3000 IU/mL received 18 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 75 mg SC
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received 75 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 300 mg SC
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received 300 mg VIR-3434 subcutaneous
|
Part B: HBV Participants Placebo
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received placebo subcutaneous
|
Part C: HBV Participants 18 mg SC
HBV Participants on NRTI therapy with HBsAg \>/= 3000 IU/mL received 18 mg VIR-3434 subcutaneous
|
Part C: HBV Participants 75 mg SC
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received 75 mg VIR-3434 subcutaneous
|
Part C: HBV Participants 300 mg SC
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received 300 mg VIR-3434 subcutaneous
|
Part C: HBV Participants Placebo
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received placebo subcutaneous
|
Part D: HBV Participants 75 mg SC
HBV Participants not on NRTI therapy with HBV DNA \>/= 1000 and any HBsAg level received 75 mg VIR-3434 subcutaneous
|
Part D: HBV Participants 300 mg SC
HBV Participants not on NRTI Therapy with HBV DNA \>/= 1000 and any HBsAg level received 300 mg VIR-3434 subcutaneous
|
Part D: HBV Participants Placebo
HBV Participants not on NRTI Therapy with HBV DNA \>/= 1000 IU/mL and any HBsAg level received placebo subcutaneous
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUClast
|
302 Part A: day*µg/mL
Geometric Coefficient of Variation 16.0
|
964 Part A: day*µg/mL
Geometric Coefficient of Variation 22.6
|
3060 Part A: day*µg/mL
Geometric Coefficient of Variation 19.8
|
4010 Part A: day*µg/mL
Geometric Coefficient of Variation 28.5
|
12300 Part A: day*µg/mL
Geometric Coefficient of Variation 19.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Part A: Healthy Participants 90 mg SC
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part A Healthy Participants 300 mg SC
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part A Healthy Participants 900 mg SC
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part A Healthy Participants 900 mg IV
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part A: Healthy Participants 3000 mg IV
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A Healthy Participants Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part B: HBV Participants 6 mg SC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part B: HBV Participants 18 mg SC
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part B: HBV Participants 75 mg SC
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part B: HBV Participants 300 mg SC
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part B: HBV Participants Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part C: HBV Participants 18 mg SC
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part C: HBV Participants 75 mg SC
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part C: HBV Participants 300 mg SC
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Part C: HBV Participants Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part D: HBV Participants 75 mg SC
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part D: HBV Participants 300 mg SC
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part D: HBV Participants Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A: Healthy Participants 90 mg SC
n=6 participants at risk
Healthy participants received 90 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 300 mg SC
n=6 participants at risk
Healthy participants received 300 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 900 mg SC
n=6 participants at risk
Healthy participants received 900 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 900 mg IV
n=6 participants at risk
Healthy Participants received 900 mg VIR-3434 intravenously
|
Part A: Healthy Participants 3000 mg IV
n=6 participants at risk
Healthy participants received 3000 mg VIR-3434 intravenously
|
Part A Healthy Participants Placebo
n=11 participants at risk
Healthy participants received placebo subcutaneously or intravenously
|
Part B: HBV Participants 6 mg SC
n=6 participants at risk
HBV Participants on NRTI therapy with HBsAg \<3000 IU/mL received 6 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 18 mg SC
n=6 participants at risk
HBV Participants on NRTI therapy with HBsAg \<3000 IU/mL received 18 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 75 mg SC
n=6 participants at risk
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received 75 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 300 mg SC
n=6 participants at risk
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received 300 mg VIR-3434 subcutaneous
|
Part B: HBV Participants Placebo
n=8 participants at risk
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received placebo subcutaneous
|
Part C: HBV Participants 18 mg SC
n=6 participants at risk
HBV Participants on NRTI therapy with HBsAg \>/= 3000 IU/mL received 18 mg VIR-3434 subcutaneous
|
Part C: HBV Participants 75 mg SC
n=6 participants at risk
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received 75 mg VIR-3434 subcutaneous
|
Part C: HBV Participants 300 mg SC
n=6 participants at risk
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received 300 mg VIR-3434 subcutaneous
|
Part C: HBV Participants Placebo
n=6 participants at risk
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received placebo subcutaneous
|
Part D: HBV Participants 75 mg SC
n=6 participants at risk
HBV Participants not on NRTI therapy with HBV DNA \>/= 1000 and any HBsAg level received 75 mg VIR-3434 subcutaneous
|
Part D: HBV Participants 300 mg SC
n=6 participants at risk
HBV Participants not on NRTI Therapy with HBV DNA \>/= 1000 and any HBsAg level received 300 mg VIR-3434 subcutaneous
|
Part D: HBV Participants Placebo
n=4 participants at risk
HBV Participants not on NRTI Therapy with HBV DNA \>/= 1000 IU/mL and any HBsAg level received placebo subcutaneous
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Immune system disorders
Anaphylactic Reaction
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/11 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/8 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
16.7%
1/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/4 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
Other adverse events
| Measure |
Part A: Healthy Participants 90 mg SC
n=6 participants at risk
Healthy participants received 90 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 300 mg SC
n=6 participants at risk
Healthy participants received 300 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 900 mg SC
n=6 participants at risk
Healthy participants received 900 mg VIR-3434 subcutaneous
|
Part A Healthy Participants 900 mg IV
n=6 participants at risk
Healthy Participants received 900 mg VIR-3434 intravenously
|
Part A: Healthy Participants 3000 mg IV
n=6 participants at risk
Healthy participants received 3000 mg VIR-3434 intravenously
|
Part A Healthy Participants Placebo
n=11 participants at risk
Healthy participants received placebo subcutaneously or intravenously
|
Part B: HBV Participants 6 mg SC
n=6 participants at risk
HBV Participants on NRTI therapy with HBsAg \<3000 IU/mL received 6 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 18 mg SC
n=6 participants at risk
HBV Participants on NRTI therapy with HBsAg \<3000 IU/mL received 18 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 75 mg SC
n=6 participants at risk
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received 75 mg VIR-3434 subcutaneous
|
Part B: HBV Participants 300 mg SC
n=6 participants at risk
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received 300 mg VIR-3434 subcutaneous
|
Part B: HBV Participants Placebo
n=8 participants at risk
HBV Participants on NRTI Therapy with HBsAg \<3000 IU/mL received placebo subcutaneous
|
Part C: HBV Participants 18 mg SC
n=6 participants at risk
HBV Participants on NRTI therapy with HBsAg \>/= 3000 IU/mL received 18 mg VIR-3434 subcutaneous
|
Part C: HBV Participants 75 mg SC
n=6 participants at risk
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received 75 mg VIR-3434 subcutaneous
|
Part C: HBV Participants 300 mg SC
n=6 participants at risk
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received 300 mg VIR-3434 subcutaneous
|
Part C: HBV Participants Placebo
n=6 participants at risk
HBV Participants on NRTI Therapy with HBsAg \>/= 3000 IU/mL received placebo subcutaneous
|
Part D: HBV Participants 75 mg SC
n=6 participants at risk
HBV Participants not on NRTI therapy with HBV DNA \>/= 1000 and any HBsAg level received 75 mg VIR-3434 subcutaneous
|
Part D: HBV Participants 300 mg SC
n=6 participants at risk
HBV Participants not on NRTI Therapy with HBV DNA \>/= 1000 and any HBsAg level received 300 mg VIR-3434 subcutaneous
|
Part D: HBV Participants Placebo
n=4 participants at risk
HBV Participants not on NRTI Therapy with HBV DNA \>/= 1000 IU/mL and any HBsAg level received placebo subcutaneous
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Pyrexia
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/11 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/8 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
16.7%
1/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
33.3%
2/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/4 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
|
General disorders
Influenza like illness
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/11 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/8 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
16.7%
1/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
16.7%
1/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/4 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
50.0%
3/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
16.7%
1/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
16.7%
1/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
16.7%
1/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
18.2%
2/11 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
16.7%
1/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
33.3%
2/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
25.0%
2/8 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
66.7%
4/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
16.7%
1/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
50.0%
3/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
25.0%
1/4 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
|
General disorders
Injection site erythema
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
50.0%
3/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
16.7%
1/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/11 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
16.7%
1/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/8 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
16.7%
1/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
16.7%
1/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/4 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
16.7%
1/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
33.3%
2/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
18.2%
2/11 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/8 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
16.7%
1/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
16.7%
1/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
16.7%
1/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/4 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
33.3%
2/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
16.7%
1/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/11 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
16.7%
1/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/8 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
16.7%
1/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
16.7%
1/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
25.0%
1/4 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
16.7%
1/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
33.3%
2/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
9.1%
1/11 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/8 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/4 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
|
General disorders
Injection Site Pain
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
33.3%
2/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/11 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/8 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
16.7%
1/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
16.7%
1/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
16.7%
1/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/4 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
16.7%
1/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/11 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/8 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
16.7%
1/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/4 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
18.2%
2/11 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/8 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
16.7%
1/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
16.7%
1/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
33.3%
2/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
50.0%
3/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/4 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
|
General disorders
Fatigue
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
16.7%
1/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/11 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
16.7%
1/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/8 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
16.7%
1/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
50.0%
3/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
16.7%
1/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/4 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
|
General disorders
Chills
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/11 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/8 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
66.7%
4/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
16.7%
1/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/4 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
|
Investigations
Leukopenia
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/11 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/8 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
16.7%
1/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
33.3%
2/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
33.3%
2/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/4 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
|
Investigations
Neutropenia
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/11 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/8 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
16.7%
1/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
16.7%
1/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
33.3%
2/6 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
0.00%
0/4 • Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Investigators may discuss or publish results after: * the study results in their entirety have been publicly disclosed by or with the consent of the Sponsor OR study has been completed at all investigative sites for at least 18 months. * provision of publication up to 60 days before planned submission to allow Sponsor to remove confidential information or identify Sponsor intellectual property Publication may be delayed as applicable, up to 120 days for Sponsor to file patent application(s)
- Publication restrictions are in place
Restriction type: OTHER