Nonalcoholic Steatohepatitis (NASH)
Conditions
Brief summary
The Safety, Tolerability, Pharmacokinetic, Pharmacodynamics and Food Effect Study of HEC96719 in Healthy Subjects
Interventions
DRUGHEC96719
Part 2：Mulltiple doses up to 10 days
Sponsors
Sunshine Lake Pharma Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability of HEC96719 by Assessment of the Number of Adverse Events | up to 17 days | To investigate the safety and tolerability of HEC96719 by assessment of AEs (non-serious and serious) following administration of oral solution in MAD |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | up to 96 hours | Maximum Plasma Concentration(Cmax)of HEC96719 |
| AUC | up to 96 hours | Area Under the Curve(AUC) of HEC96719 |
| Tmax | up to 96 hours | Maximum Peak Time(Tmax) of HEC96719 |
| T1/2 | up to 96 hours | Maximum Peak Time(Tmax) of HEC96719 |
Countries
China
Outcome results
None listed