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The Tolerability , Pharmacokinetics and Pharmacodynamics Study of HEC96719 Tablets in Healthy Adult Subjects | Clinical Trials | Clareo Health

COMPLETEDPHASE1

The Tolerability , Pharmacokinetics and Pharmacodynamics Study of HEC96719 Tablets in Healthy Adult Subjects

A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Access the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HEC96719 Tablets in Chinese Healthy Volunteers

NCT04194242•Sunshine Lake Pharma Co., Ltd.

View on ClinicalTrials.gov

Summary

This study is a safety, tolerability, and pharmacokinetics phase Ⅰstudy of HEC96719, in healthy subjects.This study is the healthy adult subjects single ascending-dose research

Detailed Description

This study will evaluate the safety and tolerability of escalating single oral doses of HEC96719, and characterize the single-dose pharmacokinetics (PK) of HEC96719. Participants will receive either HEC96719 or HEC96719 placebo.

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Willing to participate in the study, able to understand and sign the informed consent, and able to complete the the study in accordance with the requirements of the study.
•Female subjects who are not pregnant or lactating and male subjects whose female partners are fertile shall voluntarily take effective contraceptive measures from the date of signing the informed consent form to 3 months after the medication.
•When signing the informed consent, 18 years old ≤the age≤45 years old(including the critical value), gender is not limited.
•Male body weight ≥50kg, female body weight ≥45kg, and body mass index (BMI) in the range of 18-28 kg/m2 (including the critical value).
•No clinical significance of vital signs, physical examination, laboratory examination, electrocardiogram, ultrasound abdomen and chest X-ray (posterior and anterior) results.

Exclusion Criteria

•Positive for Viral hepatitis (including hepatitis B and C), HIV and syphilis.
•Those who are known to have allergy history or allergy constitution to the test preparation and any of its components or related preparations.
•Intemperant or regular drinkers within 3 months prior to the study, i.e., those who consumed more than 21 units of alcohol per week (1 unit =360mL beer or 45mL spirit with 40% alcohol or 150mL wine), or those who were positive on the alcohol breath test.
•Those who had a blood donation or blood loss of \>400mL within one month before taking the study drug.
•Those who have participated in clinical trials of other drugs within 3 months before randomization.
•Subjects considered by the investigator to have other factors unsuitable for participation in this study.

Locations (1)

The Shanghai xuhui district central hospital

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

January 3, 2020

Primary Completion Date

July 17, 2020

Completion Date

July 17, 2020

Last Updated

December 28, 2020

Enrollment

ACTUAL participants

Conditions

Nonalcoholic Steatohepatitis (NASH)

Interventions

HEC96719 tablets

DRUG

Placebo tablet

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 28, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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The Tolerability , Pharmacokinetics and Pharmacodynamics Study of HEC96719 Tablets in Healthy Adult Subjects

Inclusion Criteria

Exclusion Criteria

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