Chronic Hepatitis c
Conditions
Brief summary
The Tolerability and Pharmacokinetics Study of HEC74647PA Capsule in Healthy Adult Subjects
Detailed description
A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled, Single & Multiple Ascending Dose Study to Access the Tolerability and Pharmacokinetics of HEC74647PA Capsule in Healthy Adult Subjects.
Interventions
Capsule administered orally once daily
DRUGplacebo
Matching Placebo Capsule
Sponsors
Sunshine Lake Pharma Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
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
* Able to comprehend and sign the ICF voluntarily prior to initiate the study; * Able to complete the study according to the protocol; * Between 18 and 45 years of age, inclusive, male subject should be no fertility needs; * Body weight of male and female subject should be ≥50 kg and ≥45 kg respectively; Body Mass Index (BMI) is between 18 and 28 kg/m2, inclusive; * Physical examination and vital signs without clinically significant abnormalities.
Exclusion criteria
* Smokers, who smoke more than 5 cigarettes/day within 3 months before the study; * Drink frequently, namely alcohol consumption are 14 units per week (1 unit = 285 mL of beer, or 25 mL of strong wine, or 100 mL of grape wine); * Donated blood or massive blood loss within 3 months before screening (\>450 mL）; * Have any disease that increases the risk of bleeding, such as acne, acute gastritis or stomach and duodenal ulcers; * Have taken any prescription drug, over-the-counter drug, vitamin product or herbal medicine within 1 month prior to screening; * Have participated in any clinical trial or taken any study drug within 3 months before dosing; * Viral hepatitis（including CHB and CHC）and positive test result of anti-HIV Ab or syphilis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CL/F | Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing | Oral clearance |
| Adverse events of the single ascending-dose | Baseline to day 6~13 | To assess the tolerability after a single dose of HEC74647PA capsule |
| Adverse events of the multiple ascending-dose | Baseline to day 12 | To assess the tolerability after multiple doses of HEC74647PA capsule |
| Tmax | Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing | Time of the maximum observed plasma concentration |
| AUC | Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing | Area under the plasma concentration-time curve (AUC) |
| Cmax | Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing | Maximum observed plasma concentration of HEC74647 |
| T1/2 | Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing | Terminal elimination half-life |
| Vz/F | Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing | Apparent volume of distribution |
| MRT | Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing | Mean Residence Time |
Countries
China
Outcome results
None listed