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

Sunshine Lake Pharma

Status and phase: Completed; Phase 1

Conditions: Chronic Hepatitis C

Treatments: Drug: placebo; Drug: HEC74647PA capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT04201275

HEC74647-P-02

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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28 participants in 4 patient groups, including a placebo group

Cohort 1

Experimental group

Description:

up to HEC74647PA capsule 50 mg once daily for 3 days

Treatment:

Drug: HEC74647PA capsule

Cohort 2

Experimental group

Description:

up to HEC74647PA capsule 100 mg once daily for 3 days

Treatment:

Drug: HEC74647PA capsule

Cohort 3

Experimental group

Description:

up to HEC74647PA capsule 200 mg once daily for 3 days

Treatment:

Drug: HEC74647PA capsule

Cohort 4

Placebo Comparator group

Description:

up to placebo once daily for 3 days

Treatment:

Drug: placebo