Multiple Dose Safety, Tolerability, PK，PD and Food Effect Study of HEC96719 in Healthy Adult Subjects

Nonalcoholic Steatohepatitis (NASH) Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled Study of Ascending Multiple Doses to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics，and Randomized, Open-label，Crossover, Food Effect Study of HEC96719 in Healthy Chinese Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04546984
• Other study ID #: HEC96719-P-02/CRC-C2028
• Status: Completed
• Phase: Phase 1
• Start date: September 14, 2020
• Est. completion date: December 29, 2020

Study information

• Verified date: May 2021
• Source: Sunshine Lake Pharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Safety, Tolerability, Pharmacokinetic, Pharmacodynamics and Food Effect Study of HEC96719 in Healthy Subjects

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: December 29, 2020
• Est. primary completion date: December 29, 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.

• Consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing.

• Positive results from urine drug screen test.

• Donate blood or lose blood 400 mL or more within 1 month prior to initial dosing.

• Subjects who plan to receive or have had organ transplants.

• 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
Part 2:Mulltiple doses up to 10 days

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	Safety and Tolerability of HEC96719 by Assessment of the Number of Adverse Events	To investigate the safety and tolerability of HEC96719 by assessment of AEs (non-serious and serious) following administration of oral solution in MAD	up to 17 days
Secondary	Cmax	Maximum Plasma Concentration(Cmax)of HEC96719	up to 96 hours
Secondary	AUC	Area Under the Curve(AUC) of HEC96719	up to 96 hours
Secondary	Tmax	Maximum Peak Time(Tmax) of HEC96719	up to 96 hours
Secondary	T1/2	Maximum Peak Time(Tmax) of HEC96719	up to 96 hours