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

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

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

Study Overview

• Status: Completed
• Conditions: Chronic Hepatitis C
• Intervention / Treatment: Drug: HEC110114 Tablet; Drug: Sofosbuvir Tablet

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 .

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Changchun
    • Jilin, Changchun, China, 130021
      • The First Hospital of Jilin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 600 mg multiple doses; Subjects receiving 600 mg HEC110114 tablet (N=6) or sofosbuvir tablets(N=2) once daily (q.d.) for 3 days	Drug: HEC110114 Tablet; administered orally once daily; Drug: Sofosbuvir Tablet; administered orally once daily
Experimental: 800 mg multiple doses; Subjects receiving 800 mg HEC110114 tablet (N=6) or sofosbuvir tablets(N=2) once daily (q.d.) for 3 days	Drug: HEC110114 Tablet; administered orally once daily; Drug: Sofosbuvir Tablet; administered orally once daily
Experimental: 1200 mg multiple doses; Subjects receiving 1200 mg HEC110114 tablet (N=6) or sofosbuvir tablets(N=2) once daily (q.d.) for 3 days	Drug: Sofosbuvir Tablet; administered orally once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Incidence of adverse events	From Days 1-10

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Maximum Observed Plasma Concentration	At pre-defined intervals from Days 1-7
Tmax	Time to Maximum Observed Plasma Concentration	At pre-defined intervals from Days 1-7
T1/2 T1/2 T1/2 T1/2	Apparent Half-Life	At pre-defined intervals from Days 1-7
AUClast	Area Under the Plasma Concentration vs Time Curve to Last Measurable Concentration	At pre-defined intervals from Days 1-7
HCV RNA	HCV RNA declined from baseline	At pre-defined intervals from Days 1-10

Collaborators and Investigators

• Sponsor: Sunshine Lake Pharma Co., Ltd.
• Investigators: Principal Investigator: junqi Niu, Doctor, The First Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2020
• Primary Completion (Actual): August 27, 2020
• Study Completion (Actual): August 27, 2020

Study Registration Dates

• First Submitted: December 16, 2019
• First Submitted That Met QC Criteria: December 16, 2019
• First Posted (Actual): December 18, 2019

Study Record Updates

• Last Update Posted (Actual): September 10, 2020
• Last Update Submitted That Met QC Criteria: September 9, 2020
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Hepatitis C; Hepatitis C, Chronic; Anti-Infective Agents; Antiviral Agents; Sofosbuvir
• Other Study ID Numbers: HEC110114-P-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No