A Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled, First-In- Human Study of Orally Administered EDP-323 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses, Multiple Ascending Doses, and the Effect of Food on EDP-323 Pharmacokinetics in Healthy Participants

Enanta Pharmaceuticals, Inc1 site in 1 country82 target enrollmentSeptember 29, 2022

ConditionsRSV Infection

InterventionsEDP-323 Placebo

DrugsEDP-323 Placebo

Overview

Phase: Phase 1
Intervention: EDP-323
Conditions: RSV Infection
Sponsor: Enanta Pharmaceuticals, Inc
Enrollment: 82
Locations: 1
Primary Endpoint: Safety measured by adverse events
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

September 29, 2022

End Date

March 29, 2023

Last Updated

2 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.