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

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

Official Title
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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

Conditions
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Nonalcoholic Steatohepatitis (NASH)

Intervention / Treatment
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* Drug: HEC96719


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single dose of HEC96719 （Part 1，Fed/Fasting）<br>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<br>* Part 2：Mulltiple doses up to 10 days<br>|
| Experimental: Mulltiple doses HEC96719（ Part 2, Cohort 1）<br>Healthy subjects receive multiple doses of HEC96719 or matching placebo | Drug: HEC96719<br>* Part 2：Mulltiple doses up to 10 days<br>|
| Experimental: Mulltiple doses HEC96719（ Part 2, Cohort 2）<br>Healthy subjects receive multiple doses of HEC96719 or matching placebo | Drug: HEC96719<br>* Part 2：Mulltiple doses up to 10 days<br>|
| Experimental: Mulltiple doses HEC96719（ Part 2, Cohort 3）<br>Healthy subjects receive multiple doses of HEC96719 or matching placebo | Drug: HEC96719<br>* Part 2：Mulltiple doses up to 10 days<br>|
| Experimental: Mulltiple doses HEC96719（ Part 2, Cohort 4）<br>Healthy subjects receive multiple doses of HEC96719 or matching placebo | Drug: HEC96719<br>* Part 2：Mulltiple doses up to 10 days<br>|
| Experimental: Mulltiple doses HEC96719（ Part 2, Cohort 5）<br>Healthy subjects receive multiple doses of HEC96719 or matching placebo | Drug: HEC96719<br>* Part 2：Mulltiple doses up to 10 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Maximum Plasma Concentration(Cmax)of HEC96719 | up to 96 hours | 
| AUC | Area Under the Curve(AUC) of HEC96719 | up to 96 hours | 
| Tmax | Maximum Peak Time(Tmax) of HEC96719 | up to 96 hours | 
| T1/2 | Maximum Peak Time(Tmax) of HEC96719 | up to 96 hours |