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

A Phase 1, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of VIR-3434

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).

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