NCT04991909Unknown1 期
A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics of HRS4800 in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Number of the Adverse Events that are related to the treatment from baseline to Day36
研究概览
简要总结
The study is being conducted to assess the safety and tolerability of HRS4800 after multiple oral administration with different dose regimens 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able and willing to provide a written informed consent
- •Males and females aged between 18 years and 55 years at screening, inclusive.
- •Meet the weight standard
- •Agree to take effective contraceptive methods
- •No clinically significant abnormalities in medical history, general physical examination, vital signs, laboratory tests
排除标准
- •Severe infections, injuries or surgeries or plan to undergo any surgeries.
- •ALT, AST, ALP or total bilirubin level abnormal
- •Estimated Glomerular Filtration Rate (eGFR, using CKD-EPI Creatinine Equation) is abnormal
- •Subject's supine systolic BP is >140 mmHg or <90 mmHg; diastolic BP >90 mmHg or <40 mmHg at screening/baseline visits or before dosing.
- •Subjects with cardiac and Cerebrovascular Disease
- •Positive nicotine test
- •History of regular alcohol consumption in the past 1 month exceeding an average weekly intake of 21 standard drinks
- •Positive drug screening tests
- •Positive infectious diseases screening tests
- •plan to use of any other medicine during the trial
- •Whole blood donation or loss of more than 200 mL of blood within 1 month
- •blood transfusion in the past 2 months
- •History of allergy to the study drug or any component of it.
- •Can't accept assigned meals during the trial
- •Treatment with an investigational drug within 30 days (or 5 half-lives, whichever is longer) of dosing.
- •poor tolerance or difficult for vein blood collection
- •Other conditions or laboratory abnormality that may increase the risk associated with study participation
研究组 & 干预措施
Treatment group A
Experimental
干预措施: HRS4800 (Drug)
Treatment group B
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Number of the Adverse Events that are related to the treatment from baseline to Day36
时间窗: from baseline to Day36
The severity of the Adverse Events that are related to the treatment from baseline to Day36
时间窗: from baseline to Day36
次要结局
- Cmax, Peak Concentration;(Day1)
- AUC0-tau, Area under the curve during a dose interval;(Day1)
- Tmax; The time to reach peak concentration;(Day1)
- Css,max, Peak Concentration at steady state;(Day14)
- AUCss, 0-tau, Area under the curve during a dose interval at steady state;(Day14)
- AUC0-inf, Area under the curve from 0 to infinite;(Day14)
- CL/F, apparent clearance at steady state ;(Day14)
- Vss/F; apparent volume of distribution at steady state(Day14)
- SHR175593 concentration on Day1 and day 14(Day1 and day 14)
- QTc on Day1 and Day 14(Day1 and day 14)
- Tmax, the time to reach peak concentration;(Day14)
- Ctrough trough concentration at steady state;(Day14)
- Rac, , accumulation factor;(Day14)
- t1/2, terminal half life;(Day14)
研究者
研究点 (1)
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