NCT04701216已完成1 期
A Phase 1 Open-Label Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of SHR8735 in Healthy Chinese and Caucasian Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
This is a phase 1 open-label study.
详细描述
This is a phase 1 open-label study. The objective of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of oral administered SHR8735 in healthy subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to understand the trial procedures and possible adverse events, volunteers to participate in the trial, and provides written informed consent.
- •Be able to comply with all the requirements and able to complete the study.
- •Male or female aged between 18 years and 55 years (inclusive) at the date of signed consent form.
- •No clinically significant abnormalities in medical history, general physical examination, vital signs, and laboratory tests.
- •Men and women of childbearing potential (WOCBP) must agree to take effective contraceptive methods and have no plan to have a child from signing the consent form to 16 weeks after IP administration.
排除标准
- •Receipt of any other investigational drugs or medical devices within 3 months prior to screening (according to the date of signed consent form).
- •History of illicit or prescription drug abuse or addiction within one year of screening, or positive urine drug screen at screening and Day-
- •The urine drug screen may be repeated at the discretion of the investigator and the reason for repeat needs to be documented clearly (e.g., suspicion of false positive due to diet).
- •Severe, active psychiatric conditions that require ongoing treatment.
研究组 & 干预措施
Experimental: SHR8735 cohort 1
Experimental
The subjects will receive a multiple dose of SHR8735 (low dose).
干预措施: SHR8735 (Drug)
Experimental: SHR8735 cohort 2
Experimental
The subjects will receive a single dose of SHR8735 (medium dose).
干预措施: SHR8735 (Drug)
Experimental: SHR8735 cohort 3
Experimental
The subjects will receive a single dose of SHR8735 (high dose).
干预措施: SHR8735 (Drug)
结局指标
主要结局
Adverse events
时间窗: Start of Treatment to end of study (approximately 28 days)
Incidence and severity of adverse events
次要结局
- Pharmacokinetics-AUC0-last(Start of Treatment to end of study (approximately 15 days))
- Pharmacokinetics-AUC0-inf(Start of Treatment to end of study (approximately 15 days))
- Pharmacokinetics-Tmax(Up to 15 days)
- Pharmacokinetics-Cmax(Up to 15 days)
- Pharmacokinetics-CL/F(Up to 15 days)
- Pharmacokinetics-Vz/F(Up to 15 days)
- Change from baseline to end of treatment for platelet count(Up to 28 days)
- Pharmacokinetics-t1/2(Up to 15 days)
研究者
研究点 (1)
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