The Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC110114 Tablets in HCV-infected Subjects

• Status: Completed
• Trial end date: 2020-08-27
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunshine Lake Pharma Co., Ltd.
• Treatments: Sofosbuvir

Criteria

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.