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

NCT ID: NCT03886688

Last Updated: 2023-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-14
• Study Completion Date: 2020-01-01

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

single ascending

Drug or placebo, oral, fast, single dose ascending

Group Type: EXPERIMENTAL

HEC53856

Intervention Type: DRUG

oral administration

placebo

Intervention Type: DRUG

oral administration

multiple ascending

Drug or placebo, oral, fast, multiple dose ascending

Group Type: EXPERIMENTAL

HEC53856

Intervention Type: DRUG

oral administration

placebo

Intervention Type: DRUG

oral administration

Food Effect

Drug or placebo, oral, fed or fast, single dose

Group Type: EXPERIMENTAL

HEC53856

Intervention Type: DRUG

oral administration

placebo

Intervention Type: DRUG

oral administration

Interventions

HEC53856

oral administration

Intervention Type: DRUG

placebo

oral administration

Intervention Type: DRUG

Other Intervention Names

HEC53856 capsule; HEC53856 matching placebo capsule

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sunshine Lake Pharma Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ding Yanhua, Doctor

Role: PRINCIPAL_INVESTIGATOR

The First Hospital of Jilin University

Locations

First Hospital of Jilin University

Changchun, Jilin, China

Countries

China

Other Identifiers

HEC53856-P-01

Identifier Type: -

Identifier Source: org_study_id