Overview
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.
Eligibility
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