HEC53856 Phase 1 Study - Single and Multiple Oral Dosing in Healthy Volunteers

• Status: Completed
• Trial end date: 2020-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sunshine Lake Pharma Co., Ltd.

Criteria

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