A Study in Healthy Volunteers and Patients With Chronic Hepatitis B

• Status: Completed
• Trial end date: 2018-06-12
• Target enrollment: 0
• Participant gender: All

Summary

This two-part, Phase 1 protocol will be the first clinical study of ABI-H0731. Part I will be a Phase 1a dose-ranging assessment of ABI-H0731 in healthy adult volunteers. If the dose-related safety, tolerability and pharmacokinetics (PK) of ABI-H0731 in human volunteers are deemed satisfactory, then the study will advance to Part II, a Phase 1b dose-ranging assessment of ABI-H0731 in non-cirrhotic, CHB patients.

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

Details

• Lead Sponsor: Assembly Biosciences
• Treatments: Entecavir; Peginterferon alfa-2a; Tenofovir

Criteria

Healthy volunteers:

1. Male or female between 18 and 65 years old with a BMI of 18-32kg/m2

2. Must be in good health and not have any health condition which could interfere with the absorption, distribution or elimination of study drug, or with the clinical and laboratory assessments in this study

CHB patients:

1. Male or female between 18 and 65 years of age, with a BMI of 18-35kg/m2 and a minimum body weight of 45 kg

2. Must have chronic hepatitis B with no history of clinical decompensation

3. Seropositive for HIV, HCV, or HDV antibody at Screen

4. Previous treatment with any HBV antiviral treatments within the last 3 months

5. Other known cause of liver disease, including NASH