drugset / Trial / NCT06384131
A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-4334 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-4334 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-4334 or placebo.
Timeline
- Start
- 2024-06-04
- Primary completion
- 2025-04-15
- Completion
- 2025-05-14
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | ABI-4334 | Unknown | 10 mg | Oral |
| Comparator | ABI-4334 | Unknown | 50 mg | Oral |