NCT04559126

A Study of EDP-297 in Healthy Subjects

A Randomized, Double-Blind, Placebo-Controlled, First-In-Human Study of Orally Administered EDP-297 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses (SAD), Multiple Ascending Doses (MAD), and the Effect of Food on EDP-297 Pharmacokinetics in Healthy Subjects

• 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, placebo-controlled study. It will assess the safety, tolerability, and pharmacokinetics of orally administered single and multiple doses of EDP-297 in healthy adult subjects.

Detailed description

The first phase assesses single ascending doses of EDP-297 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-297 or placebo for 14-days in healthy subjects. Each cohort within each phase will enroll a total of 8 subjects who will be randomized to receive EDP-297 or placebo. The cohort assessing food effect will enroll 10 subjects randomized to receive EDP-297 or placebo

Conditions

• NASH - Nonalcoholic Steatohepatitis With Liver Fibrosis

Interventions

Type	Name	Description
DRUG	EDP-297	EDP-297 Oral solution
DRUG	Placebo	placebo to match EDP-297

Timeline

• Start date: 2020-09-08
• Primary completion: 2021-06-21
• Completion: 2021-06-21
• First posted: 2020-09-22
• Last updated: 2021-10-29

Locations

1 site across 1 country: Netherlands