A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Studyto Evaluate the Safety, Tolerability and Pharmacokinetics of HS-10390 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation
研究概览
简要总结
The purpose of this first in human study is to evaluate the safety, tolerability, pharmacokinetics (PK),and pharmacodynamics (PD) of HS-10390 in healthy subjects.
详细描述
This is a Phase 1, randomized, double-blind, placebo-controlled, single and multiple ascendingdose (SAD and MAD) study to evaluate the safety, tolerability, PK, and PD of different doses of HS-10390 tablet(s) in healthy subjects. During the SAD and MAD periods, there will be approximately 6and 3 sequential cohorts respectively. A sentinel dosing strategy will be used in the first cohort ofSAD. The MAD study will start after sufficient safety and PK data of SAD period are obtained.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Healthy male or female subjects between the ages of 18-45 years
- •Have no reproductive potential; or agree to use a highly effective method ofcontraception, and refrain from donating sperm or eggs during the study period and forat least 6 months after last dosing
- •Have signed the informed consent form approved by the IRB
排除标准
- •History or evidence of clinically significant cardiovascular, pulmonary, endocrine,gastrointestinal, psychiatric, neurologic, hematological or metabolic diseases, especiallythose conditions that interfere with absorption, metabolism and/or excretion of the studydrug, determined by the investigator
- •Have a clinically significant infection currently or within past 30 days, or have a history ofactive tuberculosis; or have positive screening test for infectious disease, includingtuberculosis, viral hepatitis, AIDS and syphilis
- •Have a history of or current allergic disease
- •Have a history of drug or alcohol abuse or currently positive test result(s) for alcohol ordrugs of abuse
- •Smokers smoked ≥5 cigarettes per day within past 3 months or have a positive test resultfor nicotine
- •Clinically significant abnormal physical examination, vital signs, clinical laboratory values,ECGs or imaging tests
- •Pregnant or breastfeeding female subjects
研究组 & 干预措施
HS-10390
Single or multiple dosing of HS-10390 in a fastingstate
干预措施: HS-10390 tablet (Drug)
Placebo
Single or multiple dosing of placebo in a fastingstate
干预措施: Placebo tablet (Drug)
结局指标
主要结局
Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation
时间窗: Day 1 up to Day 12 (SAD), Day 1 up to Day 28 (MAD)
次要结局
- Apparent volume of distribution (Vz/F)(Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD))
- Apparent clearance (CL/F)(Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD))
- Maximum plasma concentration (Cmax)(Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD))
- Time to reach Cmax (Tmax)(Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD))
- Half time (t½)(Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD))
- Area under the plasma concentration-time curve from time zero to time t (AUC0-t)(Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD))
- Accumulation ratio（Rac）(Day 14 up to Day 19 (MAD))