A Study to Evaluate the Efficacy and Safety of Combination Therapy of BRII-179, BRII-835 and PEG-IFNα in Participants With Chronic Hepatitis B Virus (HBV) Infection (ENHANCE)

A Phase 2 Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Combination Therapy of BRII-179, BRII-835 and Pegylated Interferon Alpha (PEG-IFNα) in Participants With Chronic Hepatitis B Virus (HBV) Infection (ENHANCE)

This Phase 2, randomized, double-blind study will evaluate the clinical efficacy and safety of the combination therapy of BRII-179, BRII-835, plus PEG-IFNα compared to PEG-IFNα in adult participants with chronic HBV infection without cirrhosis receiving neucloes(t)ide reverse transcriptase inhibitors (NRTIs) as background therapy.

Inclusion Criteria:

• Male or female aged 18-60 years.
• Body mass index ≥ 18 kg/m2 and ≤ 32 kg/m2.
• Chronic HBV infection for ≥ 6 months.
• On NRTI therapy with HBV DNA < LLOQ for ≥ 6 months.
• Serum ALT and AST ≤ ULN at screening visit.

Exclusion Criteria:

• Any clinically significant chronic medical conditions other than chronic HBV infection that makes the participant unsuitable for participation in the study.
• Significant liver fibrosis or cirrhosis.
• History of clinically significant chronic liver disease from any cause other than chronic HBV infection.
• History of hepatic decompensation.
• Diagnosed or suspected hepatocellular carcinoma.
• Current or past history of infection with HIV, HCV or HDV.
• Any laboratory test abnormality that may contradict treatment with PEG-IFNα.
• Known history of immunological function impairment.
• History of intolerance to intramuscular or subcutaneous injection.