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

Vir Biotechnology

Status and phase

Completed

Phase 1

Conditions

Chronic Hepatitis B

Treatments

Other: Placebo

Biological: VIR-3434

Study type

Interventional

Funder types

Industry

Identifiers

NCT04423393

VIR-3434-1002

2019-003837-40 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment

113 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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