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

Sunshine Lake Pharma

Status and phase: Completed; Phase 2; Phase 1

Conditions: Chronic Hepatitis C

Treatments: Drug: HEC110114 Tablet; Drug: Sofosbuvir Tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT04202952

HEC110114-P-02

Details and patient eligibility

About

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

Full 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 .

Enrollment: 24 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

600 mg multiple doses

Experimental group

Description:

Subjects receiving 600 mg HEC110114 tablet (N=6) or sofosbuvir tablets(N=2) once daily (q.d.) for 3 days

Treatment:

Drug: Sofosbuvir Tablet

Drug: HEC110114 Tablet

800 mg multiple doses

Experimental group

Description:

Subjects receiving 800 mg HEC110114 tablet (N=6) or sofosbuvir tablets(N=2) once daily (q.d.) for 3 days

Treatment:

Drug: Sofosbuvir Tablet

Drug: HEC110114 Tablet

1200 mg multiple doses

Experimental group

Description:

Subjects receiving 1200 mg HEC110114 tablet (N=6) or sofosbuvir tablets(N=2) once daily (q.d.) for 3 days

Treatment:

Drug: Sofosbuvir Tablet