Chronic Hepatitis c
Conditions
Brief summary
The Tolerability and Pharmacokinetics Study of Kangdaprevir Sodium Tablet 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 Kangdaprevir Sodium Tablet in Healthy Adult Subjects.
Interventions
DRUGKangdaprevir Sodium Tablet
Tablet，administered orally once daily
DRUGplacebo
Tablet，administered orally once daily
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（18 and 45 are inclusive）; * 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（18 and 28 are 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 take any drug that changes liver enzyme activity within 1 month before taking the study drug * Have taken any prescription drug, over-the-counter drug, vitamin product or herbal medicine within 14 days 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. * Have taken any alcoholic products within 24 hours prior to taking the study drug
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | Baseline to day 13 | To assess the tolerability after a single and multiple dose of HEC84048 |
| Cmax | predose to 72 hour after dosing | Maximum observed plasma concentration of HEC84048 |
| Tmax | predose to 72 hour after dosing | Time of the maximum observed plasma concentration of HEC84048 |
| AUC | predose to 72 hour after dosing | Area under the plasma concentration-time curve (AUC) |
| T1/2 | predose to 72 hour after dosing | Terminal elimination half-life |
| Vz/F | predose to 72 hour after dosing | Apparent volume of distribution |
| CL/F | predose to 72 hour after dosing | Oral clearance |
| MRT | predose to 72 hour after dosing | Mean Residence Time |
Countries
China
Outcome results
None listed