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

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

Study Overview

• Status: Completed
• Conditions: Nonalcoholic Steatohepatitis (NASH)
• Intervention / Treatment: Drug: HEC96719 tablets; Drug: Placebo tablet

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 Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • The Shanghai xuhui district central hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: HEC96719 tablets; 0.1、0.2、0.5、1、2、3、4 mg HEC96719 tablet in day1
Placebo Comparator: placebo 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, 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.	Drug: Placebo tablet; 0.1、0.2、0.5、1、2、3、4 mg Placebo tablet in day1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events of the single ascending-dose	To assess the safe and tolerability of the single ascending-dose	From the baseline to day7

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sunshine Lake Pharma Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2020
• Primary Completion (Actual): July 17, 2020
• Study Completion (Actual): July 17, 2020

Study Registration Dates

• First Submitted: December 9, 2019
• First Submitted That Met QC Criteria: December 9, 2019
• First Posted (Actual): December 11, 2019

Study Record Updates

• Last Update Posted (Actual): December 28, 2020
• Last Update Submitted That Met QC Criteria: December 23, 2020
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: HEC96719-P-01/CRC-C1931

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No