Proof of Concept Study for Safety and Efficacy of EDP239 in Hepatitis C Subjects

Inclusion Criteria:

- Subjects must have chronic genotype-1 hepatitis C virus infection and plasma HCV-RNA
≥ 105 IU/mL at the time of screening.

- Subjects must have chronic HCV infection as determined by any of the following:

- be anti-HCV (+) for at least 6 months per subject history or medical records

- an anti-HCV test, viral load, or genotype > 6 months ago

- In the setting of a recent positive anti-HCV test (< 6 months), liver biopsy
demonstrating chronicity

- Subjects must have IL-28b genotype "CC"

- Subjects must weigh at least 50 kg to participate in the study, and must have a body
mass index (BMI) within the range of 18 - 36 kg/m2. BMI = Body weight (kg) / [Height
(m)]2

Exclusion Criteria:

- Use of other investigational drugs at the time of enrollment, or within 5 half-lives
of enrollment, or within 30 days (for small molecules) whichever is longer; or longer
if required by local regulations.

- Previous treatment, including the use of any investigational agents, for the
treatment of HCV infection.

- Women of child bearing potential.

- Subjects with IL-28b genotype "CT or TT".

- ALT γ-GT, and AST must be below 5 x the upper limit of normal (ULN).

- Serum bilirubin must not exceed ULN.

- The PT (INR) must be within normal limits.

- If necessary, laboratory testing may be repeated on one occasion (as soon as
possible) prior to randomization, to rule out any laboratory error.

- Use of drugs that inhibit or induce CYP3A4.