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

• Status: Completed
• Trial end date: 2019-10-18
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Enanta Pharmaceuticals
• 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 ≤ 30kg/m2

Exclusion Criteria:

• Pregnant or nursing females

• Acute or chronic medical illness

• Abnormal lung function

• Positive for 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