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

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

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

Study Overview

• Status: Completed
• Conditions: Nonalcoholic Steatohepatitis (NASH)
• Intervention / Treatment: Drug: HEC96719

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • The Shanghai xuhui district central hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sunshine Lake Pharma Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2020
• Primary Completion (Actual): December 29, 2020
• Study Completion (Actual): December 29, 2020

Study Registration Dates

• First Submitted: September 6, 2020
• First Submitted That Met QC Criteria: September 6, 2020
• First Posted (Actual): September 14, 2020

Study Record Updates

• Last Update Posted (Actual): May 7, 2021
• Last Update Submitted That Met QC Criteria: May 6, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: HEC96719-P-02/CRC-C2028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No