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

PHASE1CompletedINTERVENTIONAL
Enrollment

99

Participants

Timeline

Start Date

June 26, 2019

Primary Completion Date

July 14, 2021

Study Completion Date

July 14, 2021

Conditions
Chronic HBV Infection
Interventions
DRUG

EDP-514

Oral Capsule; Subjects will receive either a single dose of EDP-514 on Day 1 only (SAD HV), once daily dosing of EDP-514 starting on Day 1 through Day 14 (MAD HV) or once daily dosing of EDP-514 starting on Day 1 through Day 28 (MAD HBV).

DRUG

Placebo

Placebo to match EDP-514

Trial Locations (15)

10029

Icahn School of Medicine at Mount Sinai, New York

21228

Digestive Disease Associates - Catonsville, Catonsville

33136

University of Miami Miller School of Medicine, Miami

66219

Pharmaceutical Research Associates, Inc., Lenexa

77030

American Research Corporation, Houston

78215

The Texas Liver Institute, San Antonio

90095

University of California Los Angeles, Los Angeles

92105

Tuan Nguyen Md Gastroenterology & Hepatology (Tuan Nguyen, M.D., Inc.), San Diego

92118

Southern California GI and Liver Centers, Coronado

94115

Quest Clinical Research, San Francisco

98104

Swedish Organ Transplant and Liver Center, Seattle

T2N 4Z6

University Of Calgary, Calgary

V6Z 2K5

Gastroenterology Institute of Research Institute, Vancouver

M5G 2C4

Toronto General Hospital, Toronto

H2X 0A9

Centre Hospitalier de l'Université de Montréal, Montreal

All Listed Sponsors
collaborator

Pharmaceutical Research Associates

OTHER

lead

Enanta Pharmaceuticals, Inc

INDUSTRY