Overview

This is a Phase 1, open-label, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, and antiviral activity of PBGENE-HBV in adult participants with chronic hepatitis B.

Eligibility

Key Inclusion Criteria:

• Male or women of non-child bearing potential
• BMI 18.0 to 35.0
• Good overall health deemed by the study Investigator
• CHB infection documented at least 12 months prior to screening
• HBeAg-negative CHB
• Must be virologically suppressed on current NA treatment

Key Exclusion Criteria:

• No history of cirrhosis of the liver
• No current infections of Hepatitis A, D, and E, human immunodeficiency virus (type 1 and 2), and no history of or current hepatitis C. In addition, no other active infections deemed clinically relevant.
• No signs of hepatocellular carcinoma
• Not received an organ transplant
• No malignancy within 5 years of screening, except for specific cancers that are cured by surgical resection (e.g., basal cell skin cancer)
• No investigational agent received within 6 months of screening