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

Phase 1

Completed

• Conditions: Chronic Hepatitis C
• Interventions: Drug: HEC74647PA capsule; Drug: placebo

• Registration Number: NCT04201275
• Lead Sponsor: Sunshine Lake Pharma Co., Ltd.

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.

Study Timeline

• Study First Submitted: 2019-12-13
• Study First Submitted QC: 2019-12-13
• Study First Posted: 2019-12-17
• Study Start: 2019-12-18
• Primary Completion: 2020-01-17
• Study Completion: 2020-01-21
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-17
• Last Update Posted: 2020-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1	HEC74647PA capsule	up to HEC74647PA capsule 50 mg once daily for 3 days
Cohort 3	HEC74647PA capsule	up to HEC74647PA capsule 200 mg once daily for 3 days
Cohort 2	HEC74647PA capsule	up to HEC74647PA capsule 100 mg once daily for 3 days
Cohort 4	placebo	up to placebo once daily for 3 days

Primary Outcome Measures

Name	Time	Method
Tmax	8 days	Time of the maximum observed plasma concentration
t1/2	8 days	Terminal elimination half-life
Antiviral Activity	8 days	Change from baseline in HCV RNA following dose administration of HEC74647
Cmax	8 days	Maximum observed plasma concentration of HEC74647
Adverse Events,laboratory abnormalities and other abnormalities	8 days	Number of participants with Adverse Events, laboratory abnormalities and other abnormalities following dose administration of HEC74647
Sequence changes in the NS5A coding region	8 days	Sequence changes in the NS5A coding region of HCV following multiple dose administration of HEC74647 and for up to 8 days thereafter
AUC	8 days	Area under the plasma concentration-time curve (AUC)

Trial Locations

Locations (1)

The First Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China