NCT05246878

A Study of EDP-235 in Healthy Subjects

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Enanta Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• SARS CoV 2 Infection

Interventions

Type	Name	Description
DRUG	EDP-235	Oral administration
DRUG	Placebo	Placebo to match EDP-235, oral administration

Timeline

• Start date: 2022-01-28
• Primary completion: 2022-07-20
• Completion: 2022-07-20
• First posted: 2022-02-18
• Last updated: 2022-08-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study