drugset / Trial / NCT05414981
A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-H3733 in Subjects With Chronic Hepatitis B Virus Infection
RandomizedParallel-groupTriple-blindTreatment
Summary
This is a randomized, blinded, placebo-controlled, dose-ranging Phase 1b study of the safety, PK, and antiviral activity of ABI-H3733 in treatment-naïve or off-treatment chronic Hepatitis B virus (cHBV) subjects that are Hepatitis B e antigen (HBeAg) positive or negative. The study will enroll up to 5 sequential cohorts of 10 subjects each, for a total of up to 50 subjects, randomized 8:2 to receive ABI-H3733 or placebo.
Timeline
- Start
- 2022-08-07
- Primary completion
- 2023-04-24
- Completion
- 2023-04-24
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | ABI-H3733 | Unknown | 25 mg | Oral |
| Comparator | ABI-H3733 | Unknown | 100 mg | Oral |