Chronic Hepatitis C
Conditions
Brief summary
A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled, Single & Multiple Ascending Dose Study to Access the Tolerability and Pharmacokinetics of HEC110114 Tablets in Healthy Adult Subjects
Interventions
DRUGHEC110114 tablet
administered orally once daily
DRUGPlacebo Oral Tablet
Placebo will be administered orally at a dose and frequency matched to HEC110114
Sponsors
Sunshine Lake Pharma Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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 45 years of age inclusive * Body weight ≥ 50 kg and body mass index（BMI）between 18 and 28 kg/m2, inclusive * Physical examination and vital signs without clinically significant abnormalities.
Exclusion criteria
* Use of \>5 cigarettes per day during the past 3 months * 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 * 12-lead ECG with clinically significant * Positive for Viral hepatitis (including hepatitis B and C), HIV and syphilis * Subjects deemed unsuitable by the investigator for any other reason.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | From Days 1-12 | Percentage of Participants with Adverse Events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tmax | At pre-defined intervals from Days 1-12 | Time to Maximum Observed Plasma Concentration |
| AUClast | At pre-defined intervals from Days 1-12 | Area Under the Plasma Concentration vs Time Curve to Last Measurable Concentration |
| AUC0-∞ | At pre-defined intervals from Days 1-12 | Area Under the Plasma Concentration vs Time Curve Extrapolated to Infinity |
| Cmax | At pre-defined intervals from Days 1-12 | Maximum Observed Plasma Concentration |
| CL/F | At pre-defined intervals from Days 1-12 | Clearance (CL/F) of HEC110114 |
| Cmin | At pre-defined intervals from Days 1-11 for MAD | Trough Plasma Concentration of HEC110114 |
| T1/2 | At pre-defined intervals from Days 1-12 | Apparent Half-Life |
Countries
China
Outcome results
None listed