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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- t1/2
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Cohort 1
up to HEC74647PA capsule 50 mg once daily for 3 days
干预措施: HEC74647PA capsule (Drug)
Cohort 2
up to HEC74647PA capsule 100 mg once daily for 3 days
干预措施: HEC74647PA capsule (Drug)
Cohort 3
up to HEC74647PA capsule 200 mg once daily for 3 days
干预措施: HEC74647PA capsule (Drug)
Cohort 4
up to placebo once daily for 3 days
干预措施: placebo (Drug)
结局指标
主要结局
t1/2
时间窗: 8 days
Terminal elimination half-life
Antiviral Activity
时间窗: 8 days
Change from baseline in HCV RNA following dose administration of HEC74647
Cmax
时间窗: 8 days
Maximum observed plasma concentration of HEC74647
Adverse Events,laboratory abnormalities and other abnormalities
时间窗: 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
时间窗: 8 days
Sequence changes in the NS5A coding region of HCV following multiple dose administration of HEC74647 and for up to 8 days thereafter
Tmax
时间窗: 8 days
Time of the maximum observed plasma concentration
AUC
时间窗: 8 days
Area under the plasma concentration-time curve (AUC)
次要结局
未报告次要终点