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

• Status: Recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Enanta Pharmaceuticals, Inc
• Collaborator: hVIVO Services Limited

Criteria

Inclusion Criteria:

• An informed consent document signed and dated by the subject.

• Age 18 to 55 years, inclusive.

• In good health with no history of major medical conditions.

• A total body weight ≥ 50 kg and Body Mass Index (BMI) ≥ 18 kg/m2 and ≤ 35kg/m2.

Exclusion Criteria:

• Pregnant or nursing females

• Acute or chronic medical illness

• History of, or currently active, symptoms or signs suggestive of upper or lower respiratory tract (URT or LRT) infection within 4 weeks prior to the first study visit.

• Abnormal lung function

• Positive for HIV, active hepatitis B or C test

• Nose or nasopharynx abnormalities

• Receipt of any investigational drug within 3 months prior to the planned date of viral challenge/first dose of study drug