drugset / Trial / NCT04008004
A Study of EDP-514 in Healthy Subjects (Part 1) and Patients With Chronic Hepatitis B Virus Infection (Part 2)
Phase 1
Completed
99 enrolled
Enanta Pharmaceuticals, Inc
Pharmaceutical Research Associates · collab
RandomizedSequentialQuadruple-blindTreatment
Summary
Part 1 is a randomized, double-blind, placebo-controlled study. It will assess the safety, tolerability, and pharmacokinetics of single and multiple orally administered doses of EDP-514 in healthy adult subjects. Part 2 is randomized, double -blind, placebo-controlled study including subjects with Hepatitis B Virus. It will assess the safety, tolerability, pharmacokinetics and antiviral activity of 28 Days of orally administered doses of EDP-514 in nucleos(t)ide reverse transcriptase inhibitor (NUC)-Suppressed Patients with Chronic Hepatitis B Virus Infection
Timeline
- Start
- 2019-06-26
- Primary completion
- 2021-07-14
- Completion
- 2021-07-14
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | EDP-514 | Unknown | — | Oral |