Study of VIR-3434 in Healthy Volunteers and Patients With Chronic Hepatitis B Virus Infection

Phase 1

Completed

Conditions: Chronic Hepatitis B

Interventions: Biological: VIR-3434
Other: Placebo

Registration Number: NCT04423393

Lead Sponsor: Vir Biotechnology, Inc.

Brief 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).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 113

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VIR-3434	VIR-3434	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	Treatment-emergent period, which is up to Week 24 in part A, and up to Week 8 in part B/C/D
Number of Participants With Clinical Laboratory Abnormalities	Up to 280 days post-dose

Secondary Outcome Measures

Name	Time	Method
Cmax	Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose	VIR-3434 Maximum Concentration in Serum
Tmax	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-dose	VIR-3434 time of Cmax in Serum
AUClast	Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose	VIR-3434 under the curve from time 0 to last measurable Time
t1/2	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-dose	VIR-3434 apparent Elimination Half-life (t1/2) in serum
Vz/F	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-dose	VIR-3434 Volume of Distribution (SC only)
Vz	Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose	VIR-3434 Volume of Distribution (IV only)
CL/F	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-dose	VIR-3434 Apparent serum clearance (SC only)
CL	Part A: pre-dose and 1, 4, 6, 24 hours, 3, 7, 14, 28, 56, 84, 126, 168 days post-dose	VIR-3434 Apparent serum clearance (IV only)
Number of Participants With ADA to VIR-3434	Part A: Up to 168 days post-dose. Parts B-D: Up to 280 days post-dose	Evaluate the immunogenicity of VIR-3434
Maximum Reduction of Serum HBsAg From Baseline (Day 1 Predose)	Parts B-D: pre-dose and 1, 3, 7, 10, 14, 28, 56, 84, 112, 168, 224, 280 days post-dose	HBsAg reductions at nadir and Week 4
Part D Only: Maximum Change of HBV DNA From Baseline (Day 1 Predose)	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-dose	HBV DNA reductions at nadir and Week 4
Titers (if Applicable) of ADA to VIR-3434	Part A: Up to 168 days post-dose. Parts B-D: Up to 280 days post-dose	Evaluate the immunogenicity of VIR-3434