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

NCT ID: NCT04201275

Last Updated: 2020-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-18
• Study Completion Date: 2020-01-21

Brief 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.

Detailed 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.

Conditions

Chronic Hepatitis C

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Cohort 1

up to HEC74647PA capsule 50 mg once daily for 3 days

Group Type: EXPERIMENTAL

HEC74647PA capsule

Intervention Type: DRUG

Capsule administered orally once daily

Cohort 2

up to HEC74647PA capsule 100 mg once daily for 3 days

Group Type: EXPERIMENTAL

HEC74647PA capsule

Intervention Type: DRUG

Capsule administered orally once daily

Cohort 3

up to HEC74647PA capsule 200 mg once daily for 3 days

Group Type: EXPERIMENTAL

HEC74647PA capsule

Intervention Type: DRUG

Capsule administered orally once daily

Cohort 4

up to placebo once daily for 3 days

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

HEC74647PA capsule matching placebo administered orally once daily

Interventions

HEC74647PA capsule

Capsule administered orally once daily

Intervention Type: DRUG

placebo

HEC74647PA capsule matching placebo administered orally once daily

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sunshine Lake Pharma Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yanhua Ding, Doctor

Role: PRINCIPAL_INVESTIGATOR

The First Hospital of Jilin University

Locations

The First Hospital of Jilin University

Changchun, Jilin, China

Countries

China

Other Identifiers

HEC74647-P-02

Identifier Type: -

Identifier Source: org_study_id