Chronic Hepatitis C
Conditions
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.
Interventions
Capsule administered orally once daily
DRUGplacebo
HEC74647PA capsule matching placebo administered orally once daily
Sponsors
Sunshine Lake Pharma Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Antiviral Activity | 8 days | Change from baseline in HCV RNA 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 |
| Cmax | 8 days | Maximum observed plasma concentration of HEC74647 |
| Tmax | 8 days | Time of the maximum observed plasma concentration |
| AUC | 8 days | Area under the plasma concentration-time curve (AUC) |
| t1/2 | 8 days | Terminal elimination half-life |
Countries
China
Outcome results
None listed