Safety, Tolerability, and Antiviral Activity of ANA598 in Patients With Genotype-1 Chronic HCV Infection

A Phase 1, Randomized, Double-Blind, Ascending Multiple-Dose Study of the Safety, Tolerability, and Antiviral Activity of ANA598 in Patients With Chronic Hepatitis C Infection

The purpose of this study is to investigate the safety, tolerability, and antiviral activity of ANA598 in patients with genotype-1 chronic hepatitis C infection.

The safety, tolerability and antiviral activity of ANA598, administered orally twice daily for 3 days, will be compared to placebo in treatment-naïve subjects chronically infected with HCV genotype 1 infection. Thirty (30) subjects will be randomized to one of three cohorts described above. The ten patients in each cohort will be randomized 8 active: 2 placebo. At least 5 subjects with genotype 1a and 5 subjects with genotype 1b will be enrolled within each cohort.

Inclusion Criteria:

• Male or female, ages 18 to 65 years
• Documented chronic HCV infection, genotype 1a or 1b
• Treatment-naïve
• BMI = 18 - 35 kg/m2

Exclusion Criteria:

• Female patients who are pregnant or breast-feeding
• Previous treatment for HCV infection
• HIV or HBV positive
• Evidence of cirrhosis on previous liver biopsy or on previous imaging studies
• History of any other known cause of liver disease;