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

• Status: Completed
• Trial end date: 2020-01-21
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunshine Lake Pharma Co., Ltd.

Criteria

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