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

Sunshine Lake Pharma

Status and phase

Completed

Phase 1

Conditions

Nonalcoholic Steatohepatitis (NASH)

Treatments

Drug: HEC96719

Study type

Interventional

Funder types

Industry

Identifiers

NCT04546984

HEC96719-P-02/CRC-C2028

Details and patient eligibility

About

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

Enrollment

66 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

66 participants in 6 patient groups

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

Experimental group

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.

Treatment:

Drug: HEC96719

Mulltiple doses HEC96719（ Part 2, Cohort 1）

Experimental group

Description: