NCT03691623

A Phase 2a Study to Evaluate EDP-938 in the Virus Challenge Model

A Randomised, Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics and Antiviral Activity of Multiple Doses of Orally Administered EDP-938 Against Respiratory Syncytial Virus Infection in the Virus Challenge Model.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 179 (actual)
• Sponsor: Enanta Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A randomised, Phase 2a, double-blind, placebo-controlled study to evaluate the safety, pharmacokinetics and antiviral activity of multiple doses of orally administered EDP-938 in healthy subjects infected with RSV-A Memphis 37b. This study is designed to compare the antiviral effect of EDP-938 compared to a placebo control in the respiratory syncytial virus challenge model.

Conditions

• RSV Infection

Interventions

Type	Name	Description
DRUG	EDP-938 Dose 1	Oral suspension for 5 days
DRUG	EDP-938 Dose 2	Oral suspension for 5 days
DRUG	Placebo	Oral suspension for 5 days
DRUG	EDP-938 Dose 3	Oral suspension for 5 days
DRUG	EDP-938 Dose 4	Oral suspension for 5 days
DRUG	Placebo	Oral suspension for 5 days

Timeline

• Start date: 2018-10-15
• Primary completion: 2019-09-30
• Completion: 2019-10-18
• First posted: 2018-10-02
• Last updated: 2022-05-03
• Results posted: 2022-05-03

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study