NCT05587478

A Study of EDP-323 in Healthy Subjects

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Enanta Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• RSV Infection

Interventions

Type	Name	Description
DRUG	EDP-323	Oral administration
DRUG	Placebo	Placebo to match EDP-323, oral administration

Timeline

• Start date: 2022-09-29
• Primary completion: 2023-03-29
• Completion: 2023-03-29
• First posted: 2022-10-20
• Last updated: 2023-09-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study