NCT06170242

A Controlled Phase 2a Study to Evaluate the Efficacy of EDP-323 Against Respiratory Syncytial Virus Infection in a Virus Challenge Model

A Randomized, Phase 2a, Double-blind, Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics and Antiviral Activity of Multiple Doses of Orally Administered EDP-323 Against Respiratory Syncytial Virus Infection in a Virus Challenge Model in Healthy Adults

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 142 (actual)
• Sponsor: Enanta Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A randomized, Phase 2a, double-blind, placebo-controlled study to evaluate the safety, pharmacokinetics and antiviral activity of multiple doses of orally administered EDP-323 in healthy subjects infected with RSV-A Memphis 37b. This study is designed to assess the antiviral effect of EDP-323 compared to a placebo control in the respiratory syncytial virus challenge model.

Conditions

• RSV Infection

Interventions

Type	Name	Description
DRUG	EDP-323 Dose Regimen 1	EDP-323 capsule
DRUG	EDP-323 Dose Regimen 2	EDP-323 capsule
DRUG	Placebo	Placebo capsule

Timeline

• Start date: 2023-11-20
• Primary completion: 2024-06-17
• Completion: 2024-07-12
• First posted: 2023-12-14
• Last updated: 2025-10-07
• Results posted: 2025-10-07

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study