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

Phase 1

Completed

• Conditions: Nonalcoholic Steatohepatitis (NASH)
• Interventions: Drug: HEC96719 tablets; Drug: Placebo tablet

• Registration Number: NCT04194242
• Lead Sponsor: Sunshine Lake Pharma Co., Ltd.

Brief 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.

Study Timeline

• Status Verified: 2019-12
• Study First Submitted: 2019-12-09
• Study First Submitted QC: 2019-12-09
• Study First Posted: 2019-12-11
• Study Start: 2020-01-03
• Primary Completion: 2020-07-17
• Study Completion: 2020-07-17
• Last Update Submitted: 2020-12-23
• Last Update Posted: 2020-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HEC96719 tablets	HEC96719 tablets	Including 7 dose groups(0.1、0.2、0.5、1、2、3、4 mg).Each dose group was given only once.After an overnight stay of at least 10h on an empty stomach, 240 mL of water was administered in the morning under the condition of an empty stomach. Water was forbidden for 1h before and 1h after administration, and fasting for 4h after administration.
placebo tablets	Placebo tablet	Including 7 dose groups(0.1、0.2、0.5、1、2、3、4 mg).Each dose group was given only once.After an overnight stay of at least 10h on an empty stomach, 240mL of water was administered in the morning under the condition of an empty stomach. Water was forbidden for 1h before and 1h after administration, and fasting for 4h after administration.

Primary Outcome Measures

Name	Time	Method
Adverse events of the single ascending-dose	From the baseline to day7	To assess the safe and tolerability of the single ascending-dose

Secondary Outcome Measures

Name	Time	Method
Tmax	At pre-defined intervals from Days 1-2	Maximum Peak Time(Tmax) of HEC96719 in single ascending dose
Cmax	At pre-defined intervals from Days 1-2	Maximum Plasma Concentration(Cmax)of HEC96719 in single ascending dose
AUC	At pre-defined intervals from Days 1-2	Area Under the Curve(AUC) of HEC96719 in single ascending dose
T1/2	At pre-defined intervals from Days 1-2	Terminal elimination half-life(T1/2) of HEC96719 in single ascending dose

Trial Locations

Locations (1)

The Shanghai xuhui district central hospital; 🇨🇳 Shanghai, Shanghai, China