A Study of EDP-938 in Healthy Subjects

A Randomized, Double-Blind, Placebo-Controlled, First-In-Human Study of Orally Administered EDP-938 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses (SAD), Multiple Ascending Doses (MAD) and the Effect of Food on EDP-938 Pharmacokinetics in Healthy Subjects

This randomized, double-blind, placebo-controlled study will assess the safety, tolerability, and pharmacokinetics of single and multiple orally administered doses of EDP-938 in healthy adult subjects

The first phase assesses single ascending doses for EDP-938 (active drug or placebo) in healthy subjects. A "fasted" and "fed" two-part cohort will also assess food effect.

The second phase assesses multiple ascending doses (active drug or placebo) for 7-days in healthy subjects.

Each cohort within each phase will enroll a total of 8 subjects who will be randomized to receive EDP-938 or placebo. The cohort assessing food effect will enroll 10 subjects randomized to receive EDP-938 or placebo.

Inclusion Criteria:

• An informed consent document signed and dated by the subject.
• Healthy male and female subjects of any ethnic origin between the ages of 18 and 55 years, inclusive.

Exclusion Criteria:

• Clinically relevant evidence or history of illness or disease.
• Pregnant or nursing females.
• History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection.
• A positive urine drug screen at screening or Day -1.
• Current tobacco smokers or use of tobacco within 3 months prior to screening.
• Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy).
• History of regular alcohol consumption.
• Participation in a clinical trial within 30 days prior to the first dose of study drug.