Study of VIR-2218 in Healthy Volunteers and Patients With Chronic Hepatitis B

• Status: Completed
• Trial end date: 2020-09-03
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase 1/2 study in which healthy volunteers and subjects with chronic HBV infection will receive VIR-2218 or placebo and will be assessed for safety, tolerability, pharmacokinetics, and antiviral activity (only in subjects with chronic HBV).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Vir Biotechnology, Inc.
• Collaborator: Alnylam Pharmaceuticals

Criteria

Healthy Volunteers:

Inclusion Criteria:

• Male or female age 18 - 55

• BMI 18 - 32 kg/m^2

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 intolerance to SC injection

CHB Patients:

Inclusion Criteria:

• Male or female age 18 - 65

• BMI 18 - 32 kg/m^2

• Chronic HBV infection for >/= 6 months

Exclusion Criteria:

• Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation

• Significant fibrosis or cirrhosis

• History or evidence of drug or alcohol abuse

• History of intolerance to SC injection

• History of chronic liver disease from any cause other than chronic HBV infection

• History of hepatic decompensation