Healthy
Conditions
Brief summary
To evaluate the safety, tolerability and pharmacokinetics of HEC53856 after single or multiple oral administration, as well as the food effect on the pharmacokinetics, in healthy non-elderly subjects.
Detailed description
This is a Phase I, Single Center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Tolerability and Pharmacokinetics of HEC53856 capsule in Healthy Adult Subjects. The study consists of three parts, single dose ascending, multiple dose ascending and food effect testing. Within each part participants will be randomized to either drug or placebo.
Interventions
DRUGHEC53856
oral administration
DRUGplacebo
oral administration
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
* healthy volunteers * age: 18-45 years old(18 and 45 included). * B.W. male\> 50kg, female\> 45kg, BMI - 18-28 kg/m\^2 * females must not be pregnant and males and females must agree to use contraception during the study. * able to give informed consent and comply with protocol. * physical examination and vital signs without clinically significant abnormalities. * agree to use contraceptive methods after informed consent acquisition through 6 months after the last administration of the study drug.
Exclusion criteria
* history or presence of severe gastrointestinal or systemic disorders (e.g. respiratory, endocrine, immunological, dermatological, neurological, psychiatric, renal, hepatic disease etc.) * history or presence of significant alcoholism or drug abuse within past 5 years * smokers, who smoke more than 5 cigarettes per day within past 3 months * heavy drinker, 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 or thrombus, such as acute gastritis or stomach and duodenal ulcers; * clinically significant laboratory findings during screening * history or presence of clinically significant ECG abnormalities * participated in drug research study within past 3 months * used over-the-counter/ prescription/ herbal medications/ supplements within past 14 days. * Strenuous activity (as assessed by the investigator) is prohibited from 2 weeks prior to admission until discharge from the unit. * female in pregnancy or lactation. * viral hepatitis（including CHB and CHC）and positive test result of anti-HIV Ab or syphilis. * the investigator believes that the one should not be included
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events [Safety and Tolerability] | Up to Day 10 after last dose | To assess the safety and tolerability by incidence of treatment-emergent adverse events after a single dose or multiple doses of HEC53856 capsule |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC0-t | Up to 96 hours after dosing | Area under the concentration versus time curve (AUC) from time zero to the time of the last quantifiable concentration |
| Cmax | Up to 96 hours after dosing | Maximum observed plasma concentration |
| Tmax | Up to 96 hours after dosing | Time of the maximum observed plasma concentration |
| T T½ | Up to 96 hours after dosing | Apparent terminal elimination half-life |
Other
| Measure | Time frame | Description |
|---|---|---|
| Vz/F | Up to 96 hours after dosing | Apparent volume of distribution |
Countries
China
Outcome results
None listed