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

NCT03886688 | Completed Phase 1

• 1 other identifier: HEC53856-P-01
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events [Safety and Tolerability]

  To assess the safety and tolerability by incidence of treatment-emergent adverse events after a single dose or multiple doses of HEC53856 capsule

  Up to Day 10 after last dose

Secondary Outcomes (4)

• AUC0-t

  Up to 96 hours after dosing

• Cmax

  Up to 96 hours after dosing

• Tmax

  Up to 96 hours after dosing

• T T½

  Up to 96 hours after dosing

Other Outcomes (1)

• Vz/F

  Up to 96 hours after dosing

Study Arms (3)

single ascending

EXPERIMENTAL

Drug or placebo, oral, fast, single dose ascending

Drug: HEC53856; Drug: placebo

multiple ascending

EXPERIMENTAL

Drug or placebo, oral, fast, multiple dose ascending

Drug: HEC53856; Drug: placebo

Food Effect

EXPERIMENTAL

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

Drug: HEC53856; Drug: placebo

Interventions

HEC53856 DRUG

oral administration

Also known as: HEC53856 capsule

Food Effect; multiple ascending; single ascending

placebo DRUG

oral administration

Also known as: HEC53856 matching placebo capsule

Food Effect; multiple ascending; single ascending

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunshine Lake Pharma Co., Ltd.: lead

Study Sites (1)

First Hospital of Jilin University

Changchun, Jilin, 130000, China

Location

Study Officials

• Ding Yanhua, Doctor

  The First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: March 22, 2019
• Study Start: May 14, 2019
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: April 13, 2023

Record last verified: 2023-04

Locations

CN (1)