drugset / Trial / NCT04008004

A Study of EDP-514 in Healthy Subjects (Part 1) and Patients With Chronic Hepatitis B Virus Infection (Part 2)

NCT04008004

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

EvaluationDrugModalityDoseRoute
Subject EDP-514 Unknown Oral