The Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC74647 in HCV-infected Subjects

A Single-center, Randomized, Double-blind, Parallel, Placebo-controlled, Multiple Consecutive Dose Study to Assess the Tolerability, Pharmacokinetics and Pharmacodynamics of HEC74647 in Subjects With Chronic Hepatitis C Virus Infection

The goal of this study is to assess the tolerability, pharmacokinetics and antiviral activity of HEC74647 in HCV treatment naïve subjects with genotypes 1-6.

All subjects will be receive QD doses of HEC74647 or the matching placebo for 3 days to assess the the tolerability, pharmacokinetics and antiviral activity at specified time-points during the study.All subjects also will be monitored for up to 8 days post-dose to determine the persistence of viral mutations.

Inclusion Criteria:

• Able to comprehend and sign the ICF voluntarily prior to initiate the study;
• Able to complete the study according to the protocol;
• Agree to use protocol defined precautions against pregnancy
• Body weight of male and female subject should be ≥50 kg and ≥45 kg respectively; Body Mass Index (BMI) is between 18 and 30 kg/m2, inclusive;
• HCV treatment-naïve adult subjects with GT1-6 HCV infection
• HCV RNA level ≥ 5 log10 IU/mL at screening
• FibroScan score within 6 months≤12.5 kPa or Liver biopsy results within 12 months proved Non-cirrhosis

Exclusion Criteria:

• Smokers, who smoke more than 5 cigarettes/day within 3 months before the study;
• Drink frequently, namely alcohol consumption are 14 units per week (1 unit = 285 mL of beer, or 25 mL of strong wine, or 100 mL of grape wine);
• Donated blood or massive blood loss within 3 months before screening (>450 mL）;
• Have any disease that increases the risk of bleeding, such as acute gastritis or stomach and duodenal ulcers;
• Have taken any prescription drug, over-the-counter drug, vitamin product or herbal medicine within 14 days prior to screening;
• Have taken any drug that inhibit gastric acid secretion, such as H2 receptor antagonist famotidine and proton pump inhibitor omeprazole;
• Have participated in any clinical trial or taken any study drug within 3 months before dosing;
• Positive test result of HBV,HIV or syphilis;
• Solid organ transplanters