A Phase Ib/IIa, Single Center, Randomized, Open, Sofosbuvir-controlled, Multiple Ascending Dose Study to Access the Tolerability， Pharmacokinetics and Pharmacodynamics of HEC110114 Tablets in HCV-infected Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Adverse Events
研究概览
简要总结
A Phase Ib/IIa, Single Center, Randomized, open, Sofosbuvir-controlled, Multiple Ascending Dose Study to Access the Tolerability，Pharmacokinetics and Pharmacodynamics of HEC110114 Tablets in HCV-infected Subjects
详细描述
A total of 24 evaluable patients will be enrolled in this study. The study randomly divided into three dose groups and HEC110114 tablets planned dose levels are 600, 800, and 1200 mg, sofosbuvir tablets planned dose levels are 400 mg .
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
- None
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
- •Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions;
- •Be able to complete the study according to the trail protocol;
- •Subjects (including partners) have no pregnancy plan within six months after the last dose of study drug and voluntarily take effective contraceptive measures;
- •Male subjects and must be 18 to 65 years of age inclusive;
- •Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive, and a body weight ≥50 kg for males and ≥45 kg for females;
- •No previous treatment with any direct-acting antiviral (DAA) drugs for HCV, such as Simeprevir, Sofosbuvir, Daclatasvir etc;
- •HCV RNA ≥10*5 IU/mL at screening (Roche COBAS Taqman);
- •Chronic genotype 1-6 HCV Infection, multiple genotypes, subtype unidentifiable or others ;
- •Serum ALT ≤5 times ULN.
排除标准
- •Allergies constitution ( multiple drug and food allergies);
- •History of alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits or 100 mL of wine);
- •Donation or loss of blood over 450 mL within 3 months prior to screening;
- •History of any non-HCV liver diseases, including but not limited to hemochromatosis, primary biliary cirrhosis, Wilson's disease, autoimmune hepatitis, drug or alcoholic hepatitis, non-alcoholic steatohepatitis, etc;
- •12-lead ECG with clinically significant;
- •Pregnant or lactating women;
- •Creatinine clearance < 60 mL/min;
- •Subjects deemed unsuitable by the investigator for any other reason.
研究组 & 干预措施
600 mg multiple doses
Subjects receiving 600 mg HEC110114 tablet (N=6) or sofosbuvir tablets(N=2) once daily (q.d.) for 3 days
干预措施: HEC110114 Tablet (Drug)
600 mg multiple doses
Subjects receiving 600 mg HEC110114 tablet (N=6) or sofosbuvir tablets(N=2) once daily (q.d.) for 3 days
干预措施: Sofosbuvir Tablet (Drug)
800 mg multiple doses
Subjects receiving 800 mg HEC110114 tablet (N=6) or sofosbuvir tablets(N=2) once daily (q.d.) for 3 days
干预措施: HEC110114 Tablet (Drug)
800 mg multiple doses
Subjects receiving 800 mg HEC110114 tablet (N=6) or sofosbuvir tablets(N=2) once daily (q.d.) for 3 days
干预措施: Sofosbuvir Tablet (Drug)
1200 mg multiple doses
Subjects receiving 1200 mg HEC110114 tablet (N=6) or sofosbuvir tablets(N=2) once daily (q.d.) for 3 days
干预措施: Sofosbuvir Tablet (Drug)
结局指标
主要结局
Adverse Events
时间窗: From Days 1-10
Incidence of adverse events
次要结局
- Cmax(At pre-defined intervals from Days 1-7)
- T1/2 T1/2 T1/2 T1/2(At pre-defined intervals from Days 1-7)
- Tmax(At pre-defined intervals from Days 1-7)
- AUClast(At pre-defined intervals from Days 1-7)
- HCV RNA(At pre-defined intervals from Days 1-10)