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

Primary Purpose

Nonalcoholic Steatohepatitis (NASH)

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

HEC96719

About this trial

This is an interventional treatment trial for Nonalcoholic Steatohepatitis (NASH)

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

The Shanghai xuhui district central hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Arm Label

Single dose of HEC96719 （Part 1，Fed/Fasting）

Mulltiple doses HEC96719（ Part 2, Cohort 1）

Mulltiple doses HEC96719（ Part 2, Cohort 2）

Mulltiple doses HEC96719（ Part 2, Cohort 3）

Mulltiple doses HEC96719（ Part 2, Cohort 4）

Mulltiple doses HEC96719（ Part 2, Cohort 5）

Arm Description

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.

Healthy subjects receive multiple doses of HEC96719 or matching placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Cmax

Maximum Plasma Concentration(Cmax)of HEC96719

AUC

Area Under the Curve(AUC) of HEC96719

Tmax

Maximum Peak Time(Tmax) of HEC96719

T1/2

Maximum Peak Time(Tmax) of HEC96719

Full Information

NCT ID

NCT04546984

First Posted

September 6, 2020

Last Updated

May 6, 2021

Sponsor

Sunshine Lake Pharma Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04546984

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Completed

Study Start Date

September 14, 2020 (Actual)

Primary Completion Date

December 29, 2020 (Actual)

Study Completion Date

December 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sunshine Lake Pharma Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nonalcoholic Steatohepatitis (NASH)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

66 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single dose of HEC96719 （Part 1，Fed/Fasting）

Arm Type

Experimental

Arm Description

Arm Title

Mulltiple doses HEC96719（ Part 2, Cohort 1）

Arm Type

Experimental

Arm Description

Healthy subjects receive multiple doses of HEC96719 or matching placebo

Arm Title

Mulltiple doses HEC96719（ Part 2, Cohort 2）

Arm Type

Experimental

Arm Description

Healthy subjects receive multiple doses of HEC96719 or matching placebo

Arm Title

Mulltiple doses HEC96719（ Part 2, Cohort 3）

Arm Type

Experimental

Arm Description

Healthy subjects receive multiple doses of HEC96719 or matching placebo

Arm Title

Mulltiple doses HEC96719（ Part 2, Cohort 4）

Arm Type

Experimental

Arm Description

Healthy subjects receive multiple doses of HEC96719 or matching placebo

Arm Title

Mulltiple doses HEC96719（ Part 2, Cohort 5）

Arm Type

Experimental

Arm Description

Healthy subjects receive multiple doses of HEC96719 or matching placebo

Intervention Type

Drug

Intervention Name(s)

HEC96719

Intervention Description

Part 2：Mulltiple doses up to 10 days

Primary Outcome Measure Information:

Title

Safety and Tolerability of HEC96719 by Assessment of the Number of Adverse Events

Description

To investigate the safety and tolerability of HEC96719 by assessment of AEs (non-serious and serious) following administration of oral solution in MAD

Time Frame

up to 17 days

Secondary Outcome Measure Information:

Title

Cmax

Description

Maximum Plasma Concentration(Cmax)of HEC96719

Time Frame

up to 96 hours

Title

AUC

Description

Area Under the Curve(AUC) of HEC96719

Time Frame

up to 96 hours

Title

Tmax

Description

Maximum Peak Time(Tmax) of HEC96719

Time Frame

up to 96 hours

Title

T1/2

Description

Maximum Peak Time(Tmax) of HEC96719

Time Frame

up to 96 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

The Shanghai xuhui district central hospital

City

Shanghai

State/Province

Shanghai

Country

China

12. IPD Sharing Statement

Plan to Share IPD

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

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