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

Sponsor

Sunshine Lake Pharma Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT04546984

Collaborator

(none)

Enrollment

Location

Arms

3.5

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Nonalcoholic Steatohepatitis (NASH)	Drug: HEC96719	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

66 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Sep 14, 2020

Actual Primary Completion Date :

Dec 29, 2020

Actual Study Completion Date :

Dec 29, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single dose of HEC96719 （Part 1，Fed/Fasting） Following an overnight fast of at least 10 hours, a single dose of HEC96719 will be administered on 2 separate occasions (fasting and after meal) in a randomized crossover fashion with different food restrictions.	Drug: HEC96719 Part 2：Mulltiple doses up to 10 days
Experimental: Mulltiple doses HEC96719（ Part 2, Cohort 1） Healthy subjects receive multiple doses of HEC96719 or matching placebo	Drug: HEC96719 Part 2：Mulltiple doses up to 10 days
Experimental: Mulltiple doses HEC96719（ Part 2, Cohort 2） Healthy subjects receive multiple doses of HEC96719 or matching placebo	Drug: HEC96719 Part 2：Mulltiple doses up to 10 days
Experimental: Mulltiple doses HEC96719（ Part 2, Cohort 3） Healthy subjects receive multiple doses of HEC96719 or matching placebo	Drug: HEC96719 Part 2：Mulltiple doses up to 10 days
Experimental: Mulltiple doses HEC96719（ Part 2, Cohort 4） Healthy subjects receive multiple doses of HEC96719 or matching placebo	Drug: HEC96719 Part 2：Mulltiple doses up to 10 days
Experimental: Mulltiple doses HEC96719（ Part 2, Cohort 5） Healthy subjects receive multiple doses of HEC96719 or matching placebo	Drug: HEC96719 Part 2：Mulltiple doses up to 10 days

Outcome Measures

Primary Outcome Measures

Safety and Tolerability of HEC96719 by Assessment of the Number of Adverse Events [up to 17 days]
To investigate the safety and tolerability of HEC96719 by assessment of AEs (non-serious and serious) following administration of oral solution in MAD

Secondary Outcome Measures

Cmax [up to 96 hours]
Maximum Plasma Concentration(Cmax)of HEC96719
AUC [up to 96 hours]
Area Under the Curve(AUC) of HEC96719
Tmax [up to 96 hours]
Maximum Peak Time(Tmax) of HEC96719
T1/2 [up to 96 hours]
Maximum Peak Time(Tmax) of HEC96719

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts 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.
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Shanghai xuhui district central hospital	Shanghai	Shanghai	China

Sponsors and Collaborators

Sunshine Lake Pharma Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sunshine Lake Pharma Co., Ltd.

ClinicalTrials.gov Identifier:

NCT04546984

Other Study ID Numbers:

HEC96719-P-02/CRC-C2028

First Posted:

Sep 14, 2020

Last Update Posted:

May 7, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Fatty Liver

Non-alcoholic Fatty Liver Disease

Study Results

No Results Posted as of May 7, 2021