A Study of EDP-297 in Healthy Subjects

The first phase assesses single ascending doses of EDP-297 or placebo in healthy subjects. A "fasted" and "fed" two-part cohort will also assess food effect.

The second phase assesses multiple ascending doses of EDP-297 or placebo for 14-days in healthy subjects.

Each cohort within each phase will enroll a total of 8 subjects who will be randomized to receive EDP-297 or placebo. The cohort assessing food effect will enroll 10 subjects randomized to receive EDP-297 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 65 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 -2.
• Current tobacco smokers or use of tobacco within 1 months prior to screening.
• Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy).
• History of regular alcohol consumption exceeding 14 drinks/week for females and 21 drinks/week for males within 6 months of Screening.
• Participation in a clinical trial within 30 days prior to the first dose of study drug.