NCT04229433已完成1 期
A Phase I, Randomized, Single -Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR2285 Tablets in Healthy 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
- 36
- 试验地点
- 1
- 主要终点
- Number of subjects with adverse events and serious adverse events.
研究概览
简要总结
The study is a randomized, single-blind, placebo-controlled, multiple-dose escalation Phase I trials. 2 dose groups were designed, 12 subjects in each dose group.The drug was administered single dose and multiple doses.
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
- Single (Participant)
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
- •males or females, aged 18-
- •subjects with no cardiovascular disease, sitting blood pressure: 90mmHg ≤SBP<140mmHg; 50mmHg ≤DBP<90mmHg and 50 ≤ HR <110 beats / min.
- •body mass index (BMI) between 18 to
- •Participant in general good health. No clinically significant findings in vital signs, physical examination, 12-lead ECG ,X-ray and laboratory parameters.
排除标准
- •males or females, aged 18-
- •subjects with no cardiovascular disease, sitting blood pressure: 90mmHg ≤SBP<140mmHg; 50mmHg ≤DBP<90mmHg and 50 ≤ HR <110 beats / min.
- •body mass index (BMI) between 18 to
- •Participant in general good health. No clinically significant findings in vital signs, physical examination, 12-lead ECG ,X-ray and laboratory parameters.
- •Exclusion Criteria:
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin/direct bilirubin > 1X ULN during screening/baseline.
- •Serum creatinine> 1X ULN during screening/baseline.
- •Abnormal coagulation function.
- •A clinical history of coagulation dysfunction; subjects with adverse reaction of antiplatelet drugs or anticoagulant drugs.
- •Subjects with severe head trauma or head surgery within 2 years or surgery within 3 months prior to the screening.
- •Blood donation or blood loss within 1 month≥200 mLor≥400 mL within 3 months before administration.
- •Human immunodeficiency virus antibody (HIV-ab), syphilis serological examination, hepatitis b virus surface antigen (HBsAg), hepatitis c virus antibody (HCV-ab) were positive.
- •8.3 months prior to screening involved in any drug or medical device clinical studies or within 5 half-life of drugs before screening.
- •9.Female subjects who did not receive contraception at least 30 days before administration.
研究组 & 干预措施
SHR2285
Experimental
Participants received one of 3 dose levels of SHR2285 administered as multiple oral doses.
干预措施: SHR2285 tablet (Drug)
SHR2285
Experimental
Participants received one of 3 dose levels of SHR2285 administered as multiple oral doses.
干预措施: Placebo (Drug)
Placebo
Experimental
Participants received one of 3 dose levels of placebo administered as multiple oral doses.
干预措施: SHR2285 tablet (Drug)
Placebo
Experimental
Participants received one of 3 dose levels of placebo administered as multiple oral doses.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of subjects with adverse events and serious adverse events.
时间窗: Pre-dose to 7 days after multiple dose administration.
次要结局
- Maximum observed serum concentration (Cmax) for single dose of SHR2285.(Pre-dose to 3 days after single dose administration)
- PK parameter will be evaluated.(Pre-dose to 3 days after single dose administration)
- Time to maximum observed serum concentration (Tmax) for single dose of SHR2285.(Pre-dose to 3 days after single dose administration)
- Apparent total clearance of the drug from plasma after oral administration (CL/F) for single dose of SHR2285.(Pre-dose to 3 days after single dose administration.)
- Accumulation ratio (Racc) for multiple dose of SHR2285.(Pre-dose to 2 days after multiple dose administration.)
- Apparent volume of distribution after non-intravenous administration (V/F) for single dose of SHR2285(Pre-dose to 3 days after single dose administration.)
- Time to elimination half-life (T1/2) for single dose of SHR2285.(Pre-dose to 3 days after single dose administration)
- Area under the plasma concentration versus time curve (AUC) for multiple dose of SHR2285.(Pre-dose to 2 days after multiple dose administration)
- Steady-state peak concentration (Cmax，ss) for multiple dose of SHR2285.(Pre-dose to 2 days after multiple dose administration)
- Steady state valley concentration (Ctrough，ss) for multiple dose of SHR2285.(Pre-dose to 2 days after multiple dose administration)
- Time to maximum observed serum concentration (Tmax) for multiple dose of SHR2285.(Pre-dose to 2 days after multiple dose administration.)
- Time to elimination half-life (T1/2) for multiple dose of SHR2285.(Pre-dose to 2 days after multiple dose administration)
- Steady-state apparent total clearance of the drug from plasma after oral administration (CLSS/F) for multiple dose of SHR2285.(Pre-dose to 2 days after multiple dose administration.)
- Steady-state apparent volume of distribution after non-intravenous administration (VSS/F) for multiple dose of SHR2285.(Pre-dose to 2 days after multiple dose administration.)
- Percentage of fluctuation (PTF%) for multiple dose of SHR2285.(Pre-dose to 2 days after multiple dose administration.)
- PD parameter will be evaluated.(Pre-dose to 2 days after multiple dose administration.)
研究者
研究点 (1)
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