Study to Investigate the Safety and Efficacy of BRII-835 and BRII-179 Combination Therapy Treating Chronic HBV Infection

• Status: Recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open label, randomized, parallel-group study to evaluate the safety and efficacy of combination treatment BRII-835 (VIR-2218) and BRII-179 (VBI-2601) in adult participants with chronic HBV infection

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brii Biosciences Limited
• Collaborators: VBI Vaccines Inc.; Vir Biotechnology, Inc.

Criteria

Inclusion Criteria:

• Male or female aged 18 - 60

• Body mass index ≥ 18 kg/m^2 and ≤ 32 kg/m^2

• Chronic HBV infection as defined by a positive serum HBsAg 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 or IM injection

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

• History of hepatic decompensation