Phase 1
N=113
Study of VIR-3434 in Healthy Volunteers and Patients With Chronic Hepatitis B Virus Infection
Chronic Hepatitis B
Bottom Line
View on ClinicalTrials.gov: NCT04423393 ↗Enrolled (actual)
113
Serious AEs
0.9%
Results posted
Oct 2024
Primary outcome: Primary: Number of Participants With Treatment-emergent Adverse Events (TEAEs) — 5; 4; 5; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- VIR-3434 (Biological); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vir Biotechnology, Inc.
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
5; 4; 5; 4; 3; 6 | — |
| PRIMARY Number of Participants With Clinical Laboratory Abnormalities |
0; 1; 1; 0; 2; 0 | — |
| SECONDARY Cmax |
9.46; 32.1; 105; 363; 1060 | — |
| SECONDARY Tmax |
7.00; 7; 3; .0833; .0833; 6.90 | — |
| SECONDARY AUClast |
302; 964; 3060; 4010; 12300 | — |
| SECONDARY t1/2 |
28.5; 24.3; 25.2; 24.0; 20.7; 3.57 | — |
| SECONDARY Vz/F |
12200; 10900; 10600; 9420; 4540; 7410 | — |
| SECONDARY Vz |
7620; 7290 | — |
| SECONDARY CL/F |
295; 308; 292; 1950; 496; 697 | — |
| SECONDARY CL |
244; 1950 | — |
| SECONDARY Number of Participants With ADA to VIR-3434 |
0; 1; 1; 0; 0; 0 | — |
| SECONDARY Maximum Reduction of Serum HBsAg From Baseline (Day 1 Predose) |
-1.30; -1.27; -1.96; -2.24; -0.04; -1.05 | — |
| SECONDARY Part D Only: Maximum Change of HBV DNA From Baseline (Day 1 Predose) |
-1.44; -2.07; -0.12; -0.70; -0.61; 0.06 | — |
| SECONDARY Titers (if Applicable) of ADA to VIR-3434 |
0; 20; 160; 0; 0; 0 | — |
| SECONDARY Cmax |
9.46; 32.1; 105; 363; 1060 | — |
| SECONDARY AUClast |
302; 964; 3060; 4010; 12300 | — |
Summary
This is a Phase 1 study in which healthy volunteers and participants with chronic HBV infection will receive VIR-3434 or placebo and will be assessed for safety, tolerability, pharmacokinetics (PK), and antiviral activity (only in participants with chronic HBV infection).
Eligibility Criteria
Healthy Volunteers:
Inclusion Criteria
- Male or female age 18 - 55
- Weight 40-125 kg
Exclusion Criteria
- Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation
- History or evidence of drug or alcohol abuse
- History of allergic reactions to monoclonal antibodies or antibody fragments
- History of anaphylaxis
CHB Patients:
Inclusion Criteria
- Male or female age 18 - 65
- Weight 40-125 kg
- Chronic HBV infection for >/= 6 months
Exclusion Criteria
- Any clinically significant chronic or acute medical condition that makes the participant unsuitable for participation
- Significant fibrosis or cirrhosis
- History or evidence of drug or alcohol abuse
- History of chronic liver disease from any cause other than chronic HBV infection
- History of hepatic decompensation
- History of anaphylaxis
- History of allergic reactions to monoclonal antibodies or antibody fragments
- History of immune complex disease
- Active infection with HIV, HCV or hepatitis Delta virus
Data sourced from ClinicalTrials.gov (NCT04423393). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.