Back to results

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

Primary Purpose

Nonalcoholic Steatohepatitis (NASH)

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

HEC96719 tablets

Placebo tablet

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.
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.

Sites / Locations

The Shanghai xuhui district central hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

HEC96719 tablets

placebo tablets

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Adverse events of the single ascending-dose

To assess the safe and tolerability of the single ascending-dose

Secondary Outcome Measures

Cmax

Maximum Plasma Concentration(Cmax)of HEC96719 in single ascending dose

AUC

Area Under the Curve(AUC) of HEC96719 in single ascending dose

Tmax

Maximum Peak Time(Tmax) of HEC96719 in single ascending dose

T1/2

Terminal elimination half-life(T1/2) of HEC96719 in single ascending dose

Full Information

NCT ID

NCT04194242

First Posted

December 9, 2019

Last Updated

December 23, 2020

Sponsor

Sunshine Lake Pharma Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04194242

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Completed

Study Start Date

January 3, 2020 (Actual)

Primary Completion Date

July 17, 2020 (Actual)

Study Completion Date

July 17, 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

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

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.

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

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HEC96719 tablets

Arm Type

Experimental

Arm Description

Arm Title

placebo tablets

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

HEC96719 tablets

Intervention Description

0.1、0.2、0.5、1、2、3、4 mg HEC96719 tablet in day1

Intervention Type

Drug

Intervention Name(s)

Placebo tablet

Intervention Description

0.1、0.2、0.5、1、2、3、4 mg Placebo tablet in day1

Primary Outcome Measure Information:

Title

Adverse events of the single ascending-dose

Description

To assess the safe and tolerability of the single ascending-dose

Time Frame

From the baseline to day7

Secondary Outcome Measure Information:

Title

Cmax

Description

Maximum Plasma Concentration(Cmax)of HEC96719 in single ascending dose

Time Frame

At pre-defined intervals from Days 1-2

Title

AUC

Description

Area Under the Curve(AUC) of HEC96719 in single ascending dose

Time Frame

At pre-defined intervals from Days 1-2

Title

Tmax

Description

Maximum Peak Time(Tmax) of HEC96719 in single ascending dose

Time Frame

At pre-defined intervals from Days 1-2

Title

T1/2

Description

Terminal elimination half-life(T1/2) of HEC96719 in single ascending dose

Time Frame

At pre-defined intervals from Days 1-2

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. 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.

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

Learn more about this trial

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

We'll reach out to this number within 24 hrs