NCT07101965已完成1 期
Phase I Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RSS0343 Tablets in Healthy Subjects After Single and Multiple Oral Administration and the Effect of Food on the Pharmacokinetics of RSS0343
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
- 72
- 试验地点
- 1
- 主要终点
- adverse events
研究概览
简要总结
To evaluate the safety and tolerability of RSS0343 tablets in healthy subjects after single and multiple oral administration
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
- •Age of 18-55 years old (inclusive), male or female;
- •Body mass index in the range of 19-28 kg/m2 (inclusive).
排除标准
- •The results of physical examination, vital signs, laboratory tests, chest imaging, abdominal B ultrasound and 12-lead electrocardiogram were abnormal.
- •Hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, HIV antibody positive;
- •Suspected allergy to the study drug or any component of the study drug, or severe allergy to any drug, food, toxin or other exposure;
- •Current active, latent, or inadequately treated M. tuberculosis (i.e., tuberculosis [TB]) infection;
- •Investigator-assessed clinically significant infection (e.g., requiring hospitalization or parenteral antimicrobial therapy) within 1 month before screening; A history of more than one previous episode of herpes zoster, or disseminated herpes zoster (one episode); Any history of other infections that the investigator considered might have been aggravated by study participation.
研究组 & 干预措施
Treatment group 1: RSS0343 tablets or placebo
Experimental
干预措施: RSS0343 tablets ；placebo (Drug)
Treatment group 2: RSS0343 tablets or placebo
Experimental
干预措施: RSS0343 tablets ；placebo (Drug)
Treatment group 3: RSS0343 tablets or placebo
Experimental
干预措施: RSS0343 tablets ；placebo (Drug)
Treatment group 4: RSS0343 tablets or placebo
Experimental
干预措施: RSS0343 tablets ；placebo (Drug)
Treatment group 5: RSS0343 tablets or placebo
Experimental
干预措施: RSS0343 tablets ；placebo (Drug)
Treatment group 6: RSS0343 tablets or placebo
Experimental
干预措施: RSS0343 tablets ；placebo (Drug)
Treatment group 7: RSS0343 tablets or placebo
Experimental
干预措施: RSS0343 tablets ；placebo (Drug)
Treatment group 8: RSS0343 tablets or placebo
Experimental
干预措施: RSS0343 tablets ；placebo (Drug)
结局指标
主要结局
adverse events
时间窗: The observation lasted until the 61th day
次要结局
- Vz/F(The observation lasted until the 33th day)
- Cmax(The observation lasted until the 33th day)
- AUC0-t(The observation lasted until the 33th day)
- AUC0-inf(The observation lasted until the 33th day)
- Tmax(The observation lasted until the 33th day)
- fe,urine(The observation lasted until the 33th day)
- Relative bioavailability of premeal and postmeal administration(The observation lasted until the 16th day)
- Neutrophil elastase (NE) activity in peripheral blood after repeated oral administration of RSS0343(The observation lasted until the 61th day)
- t1/2(The observation lasted until the 33th day)
- CL/F(The observation lasted until the 33th day)
- Ae,urine(The observation lasted until the 33th day)
研究者
研究点 (1)
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