Clinical trial NCT04194242: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Nonalcoholic Steatohepatitis (NASH)
Lead sponsor: Sunshine Lake Pharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-12-11
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Adverse events of the single ascending-dose
timeFrame: From the baseline to day7
Secondary outcomes:
measure: Cmax
timeFrame: At pre-defined intervals from Days 1-2
measure: AUC
timeFrame: At pre-defined intervals from Days 1-2
measure: Tmax
timeFrame: At pre-defined intervals from Days 1-2
measure: T1/2
timeFrame: At pre-defined intervals from Days 1-2
Other outcomes:
Locations:
city: Shanghai
country: China
facility: The Shanghai xuhui district central hospital
state: Shanghai
Study officials:
References: