Clinical trial NCT04202952: The Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC110114 Tablets in HCV-infected Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Chronic Hepatitis C
Lead sponsor: Sunshine Lake Pharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-12-18
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .

Eligibility 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.

Primary outcomes:
measure: Adverse Events
timeFrame: From Days 1-10
Secondary outcomes:
measure: Cmax
timeFrame: At pre-defined intervals from Days 1-7
measure: Tmax
timeFrame: At pre-defined intervals from Days 1-7
measure: T1/2 T1/2 T1/2 T1/2
timeFrame: At pre-defined intervals from Days 1-7
measure: AUClast
timeFrame: At pre-defined intervals from Days 1-7
measure: HCV RNA
timeFrame: At pre-defined intervals from Days 1-10
Other outcomes:
Locations:
city: Jilin
country: China
facility: The First Hospital of Jilin University
state: Changchun
Study officials:
affiliation: The First Hospital of Jilin University
name: Junqi Niu, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Hospital of Jilin University
name: Yanhua Ding, Doctor
role: PRINCIPAL_INVESTIGATOR
References: