Overview

A Study of EDP-323 in Healthy Subjects

Status:
Recruiting
Trial end date:
2023-03-01
Target enrollment:
0
Participant gender:
All
Summary
This study is a randomized, double-blind, sponsor-open, placebo-controlled study. It will assess the safety, tolerability, and pharmacokinetics of orally administered single and multiple doses of EDP-323 in healthy adult subjects.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Enanta Pharmaceuticals, Inc
Criteria
Inclusion Criteria:

- An informed consent document signed and dated by the subject.

- Healthy male and female subjects of any ethnic origin between the ages of 18 and 65
years, inclusive.

Exclusion Criteria:

- Clinically relevant evidence or history of illness or disease.

- Infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or
hepatitis C virus (HCV) at screening and infection with SARS-CoV-2 at the Day -1 visit

- Pregnant or nursing females.

- History of febrile illness within 7 days prior to the first dose of study drug or
subjects with evidence of active infection.

- A positive urine drug screen at screening or Day -1.

- Current tobacco smokers or use of tobacco within 3 months prior to screening.

- Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy).

- History of regular alcohol consumption.

- Receipt of any vaccine, an investigational agent or biological product within 28 days
or 5 times the t½, whichever one is longer, prior to first dose.