Clinical trial NCT04201275: The Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC74647 in HCV-infected Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Hepatitis C
Lead sponsor: Sunshine Lake Pharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-12-17
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Adverse Events,laboratory abnormalities and other abnormalities
timeFrame: 8 days
measure: Antiviral Activity
timeFrame: 8 days
measure: Sequence changes in the NS5A coding region
timeFrame: 8 days
measure: Cmax
timeFrame: 8 days
measure: Tmax
timeFrame: 8 days
measure: AUC
timeFrame: 8 days
measure: t1/2
timeFrame: 8 days
Secondary outcomes:
Other outcomes:
Locations:
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
Study officials:
affiliation: The First Hospital of Jilin University
name: Yanhua Ding, Doctor
role: PRINCIPAL_INVESTIGATOR
References: