The Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC110114 Tablets in HCV-infected Subjects
Phase 1
Completed
- Conditions
- Chronic Hepatitis C
- Interventions
- Drug: HEC110114 Tablet
- Registration Number
- NCT04202952
- Lead Sponsor
- Sunshine Lake Pharma Co., Ltd.
- Brief Summary
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
- Detailed Description
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 .
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 600 mg multiple doses HEC110114 Tablet Subjects receiving 600 mg HEC110114 tablet (N=6) or sofosbuvir tablets(N=2) once daily (q.d.) for 3 days 600 mg multiple doses Sofosbuvir Tablet Subjects receiving 600 mg HEC110114 tablet (N=6) or sofosbuvir tablets(N=2) once daily (q.d.) for 3 days 800 mg multiple doses HEC110114 Tablet Subjects receiving 800 mg HEC110114 tablet (N=6) or sofosbuvir tablets(N=2) once daily (q.d.) for 3 days 800 mg multiple doses Sofosbuvir Tablet Subjects receiving 800 mg HEC110114 tablet (N=6) or sofosbuvir tablets(N=2) once daily (q.d.) for 3 days 1200 mg multiple doses Sofosbuvir Tablet Subjects receiving 1200 mg HEC110114 tablet (N=6) or sofosbuvir tablets(N=2) once daily (q.d.) for 3 days
- Primary Outcome Measures
Name Time Method Adverse Events From Days 1-10 Incidence of adverse events
- Secondary Outcome Measures
Name Time Method Cmax At pre-defined intervals from Days 1-7 Maximum Observed Plasma Concentration
T1/2 T1/2 T1/2 T1/2 At pre-defined intervals from Days 1-7 Apparent Half-Life
HCV RNA At pre-defined intervals from Days 1-10 HCV RNA declined from baseline
Tmax At pre-defined intervals from Days 1-7 Time to Maximum Observed Plasma Concentration
AUClast At pre-defined intervals from Days 1-7 Area Under the Plasma Concentration vs Time Curve to Last Measurable Concentration
Trial Locations
- Locations (1)
The First Hospital of Jilin University
🇨🇳Jilin, Changchun, China