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

Chronic Hepatitis C Clinical Trial

— HEC110114  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04202952
• Other study ID #: HEC110114-P-02
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: July 6, 2020
• Est. completion date: August 27, 2020

Study information

• Verified date: December 2019
• Source: Sunshine Lake Pharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 27, 2020
• Est. primary completion date: August 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis C
• Hepatitis C, Chronic

Intervention

Drug:
• HEC110114 Tablet
administered orally once daily
• Sofosbuvir Tablet
administered orally once daily

Locations

Country	Name	City	State
China	The First Hospital of Jilin University	Jilin	Changchun

Sponsors (1)

Lead Sponsor	Collaborator
Sunshine Lake Pharma Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	Incidence of adverse events	From Days 1-10
Secondary	Cmax	Maximum Observed Plasma Concentration	At pre-defined intervals from Days 1-7
Secondary	Tmax	Time to Maximum Observed Plasma Concentration	At pre-defined intervals from Days 1-7
Secondary	T1/2 T1/2 T1/2 T1/2	Apparent Half-Life	At pre-defined intervals from Days 1-7
Secondary	AUClast	Area Under the Plasma Concentration vs Time Curve to Last Measurable Concentration	At pre-defined intervals from Days 1-7
Secondary	HCV RNA	HCV RNA declined from baseline	At pre-defined intervals from Days 1-10