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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
35
ANA598 200 mg bid or placebo
ANA598 400 mg bid or placebo
ANA598 800 mg bid or placebo
United States, Missouri
St Louis, Missouri, United States
United States, New York
New York, New York, United States
United States, Texas
San Antonio, Texas, United States
Puerto Rico, Santurce
Santurce, Puerto Rico
The safety and tolerability of ascending multiple oral doses of ANA598 administered for 3 days to adult patients with chronic HCV infection and compensated liver disease;
Time frame: 10 days
The antiviral activity of ANA598, assessed by changes in serum HCV RNA levels
Time frame: 10 days
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