A Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled, First In Human Study of Orally Administered EDP-235 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses, Multiple Ascending Doses, and the Effect of Food on EDP-235 Pharmacokinetics in Healthy Participants

Enanta Pharmaceuticals, Inc1 site in 1 country72 target enrollmentJanuary 28, 2022

ConditionsSARS CoV 2 Infection

InterventionsEDP-235 Placebo

DrugsEDP-235 Placebo

Overview

Phase: Phase 1
Intervention: EDP-235
Conditions: SARS CoV 2 Infection
Sponsor: Enanta Pharmaceuticals, Inc
Enrollment: 72
Locations: 1
Primary Endpoint: Safety measured by adverse events
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study is a randomized, double-blind, placebo-controlled study. It will assess the safety, tolerability, and pharmacokinetics of orally administered single and multiple doses of EDP-235 in healthy adult subjects.

Detailed Description

The first phase assesses single ascending doses of EDP-235 or placebo in healthy subjects. A "fasted" and "fed" two-part cohort will also assess food effect. The second phase assesses multiple ascending doses of EDP-235 or placebo for 7-days in healthy subjects. Each cohort within each phase will enroll a total of 8 subjects who will be randomized to receive EDP-235 or placebo.

Registry

clinicaltrials.gov

Start Date

January 28, 2022

End Date

July 20, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Enanta Pharmaceuticals, Inc

Responsible Party

Sponsor

Eligibility 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 -
•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.