Phase 1b/2a Study of ABI-H0731 in Patients With Chronic Hepatitis B

A Phase 1b/2a, Dose-Ranging Study of the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of ABI-H0731 in Patients With Chronic Hepatitis B

The purpose of this protocol is to obtain pharmacodynamic and pharmacokinetic data on ABI-H0731 and to provide the opportunity for preliminary evaluation of combination therapy of ABI-H0731 with currently approved antiviral treatment for chronic hepatitis B.

The Phase 1b/2a assessments of the dose-related safety, PK, and initial antiviral efficacy of ABI-H0731 in hepatitis B patients will be conducted at approximately 17 different sites to meet enrollment goals of 108 chronic hepatitis B patients.

Inclusion Criteria:

• Male or female, 18 to 65 years of age
• Chronic HBV infection
• Body Mass Index (BMI) 18-38 kg/m2 and a minimum body weight of 45 kg

Exclusion Criteria:

• Seropositive for HIV, HCV, or HDV antibody at Screen
• Previous treatment with any investigational HBV antiviral treatments within the last 6 months
• Other known cause of liver disease, including NASH
• Other medical condition that requires persistent medical management or chronic or recurrent pharmacologic or surgical intervention