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

Nonalcoholic Steatohepatitis (NASH) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04194242
• Other study ID #: HEC96719-P-01/CRC-C1931
• Status: Completed
• Phase: Phase 1
• Start date: January 3, 2020
• Est. completion date: July 17, 2020

Study information

• Verified date: December 2019
• Source: Sunshine Lake Pharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: July 17, 2020
• Est. primary completion date: July 17, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fatty Liver
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Steatohepatitis (NASH)

Intervention

Drug:
• HEC96719 tablets
0.1?0.2?0.5?1?2?3?4 mg HEC96719 tablet in day1
• Placebo tablet
0.1?0.2?0.5?1?2?3?4 mg Placebo tablet in day1

Locations

Country	Name	City	State
China	The Shanghai xuhui district central hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Sunshine Lake Pharma Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events of the single ascending-dose	To assess the safe and tolerability of the single ascending-dose	From the baseline to day7
Secondary	Cmax	Maximum Plasma Concentration(Cmax)of HEC96719 in single ascending dose	At pre-defined intervals from Days 1-2
Secondary	AUC	Area Under the Curve(AUC) of HEC96719 in single ascending dose	At pre-defined intervals from Days 1-2
Secondary	Tmax	Maximum Peak Time(Tmax) of HEC96719 in single ascending dose	At pre-defined intervals from Days 1-2
Secondary	T1/2	Terminal elimination half-life(T1/2) of HEC96719 in single ascending dose	At pre-defined intervals from Days 1-2