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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Adverse events of the single ascending-dose
研究概览
简要总结
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
详细描述
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.
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.
- •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.
研究组 & 干预措施
HEC96719 tablets
Including 7 dose groups(0.1、0.2、0.5、1、2、3、4 mg).Each dose group was given only once.After an overnight stay of at least 10h on an empty stomach, 240 mL of water was administered in the morning under the condition of an empty stomach. Water was forbidden for 1h before and 1h after administration, and fasting for 4h after administration.
干预措施: HEC96719 tablets (Drug)
placebo tablets
Including 7 dose groups(0.1、0.2、0.5、1、2、3、4 mg).Each dose group was given only once.After an overnight stay of at least 10h on an empty stomach, 240mL of water was administered in the morning under the condition of an empty stomach. Water was forbidden for 1h before and 1h after administration, and fasting for 4h after administration.
干预措施: Placebo tablet (Drug)
结局指标
主要结局
Adverse events of the single ascending-dose
时间窗: From the baseline to day7
To assess the safe and tolerability of the single ascending-dose
次要结局
- Tmax(At pre-defined intervals from Days 1-2)
- Cmax(At pre-defined intervals from Days 1-2)
- AUC(At pre-defined intervals from Days 1-2)
- T1/2(At pre-defined intervals from Days 1-2)