drugset / Trial / NCT03714152
A Study of ABI-H2158 in Healthy Volunteers and Patients With Chronic Hepatitis B
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This three-part, Phase 1 protocol will be the first clinical study of ABI-H2158. Parts 1 and 2 will be a Phase 1a, dose-ranging assessment of ABI-H2158 in healthy adult volunteers. If the dose-related safety, tolerability, and pharmacokinetics (PK) of ABI-H2158 in healthy volunteers are deemed satisfactory, then the study will advance to Part 3, a Phase 1b, dose-ranging assessment of ABI-H2158 in non-cirrhotic, CHB patients.
Timeline
- Start
- 2018-11-13
- Primary completion
- 2020-11-23
- Completion
- 2021-01-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ABI-H2158 | Unknown | 5 mg | Oral |
| Subject | ABI-H2158 | Unknown | 25 mg | Oral |