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.

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.

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/m^2 and ≤ 30kg/m^2

Exclusion Criteria:

• Pregnant or nursing females
• Acute or chronic medical illness
• Abnormal lung function
• Positive for human immunodeficiency virus (HIV), active hepatitis A, 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