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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Safety and Tolerability of HEC96719 by Assessment of the Number of Adverse Events
研究概览
简要总结
The Safety, Tolerability, Pharmacokinetic, Pharmacodynamics and Food Effect Study of HEC96719 in Healthy Subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: HEC96719 (Drug)
Mulltiple doses HEC96719（ Part 2, Cohort 1）
Healthy subjects receive multiple doses of HEC96719 or matching placebo
干预措施: HEC96719 (Drug)
Mulltiple doses HEC96719（ Part 2, Cohort 2）
Healthy subjects receive multiple doses of HEC96719 or matching placebo
干预措施: HEC96719 (Drug)
Mulltiple doses HEC96719（ Part 2, Cohort 3）
Healthy subjects receive multiple doses of HEC96719 or matching placebo
干预措施: HEC96719 (Drug)
Mulltiple doses HEC96719（ Part 2, Cohort 4）
Healthy subjects receive multiple doses of HEC96719 or matching placebo
干预措施: HEC96719 (Drug)
Mulltiple doses HEC96719（ Part 2, Cohort 5）
Healthy subjects receive multiple doses of HEC96719 or matching placebo
干预措施: HEC96719 (Drug)
结局指标
主要结局
Safety and Tolerability of HEC96719 by Assessment of the Number of Adverse Events
时间窗: 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
次要结局
- T1/2(up to 96 hours)
- Cmax(up to 96 hours)
- AUC(up to 96 hours)
- Tmax(up to 96 hours)