NCT06699680已完成1 期
A Phase 1, Randomized, Double-Blind, Sponsor-Open, Placebo Controlled, First In Human Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of Single Ascending and Multiple Doses of PRX019 in Healthy Adults
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
- 50
- 试验地点
- 2
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
The purpose of this study is to assess the safety and tolerability of PRX019 in healthy adult participants.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female participants who are healthy as determined by the investigator based on review of medical history, physical examination, and clinical laboratory tests obtained during the screening period
- •Participant is willing and able to adhere to the study visit schedule and other protocol requirements
排除标准
- •Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, or clinical laboratory tests beyond what is consistent with a healthy population in the region in which the study is conducted
- •Participant was exposed to an investigational drug (new chemical entity) within 90 days preceding the first dose administration, or within 7 times the elimination half-life, if known (whichever is longer)
- •NOTE: Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
PRX019, multiple dose
Experimental
Specified dose on specified days
干预措施: Placebo (Drug)
PRX019, single dose
Experimental
Specified dose on specified days
干预措施: Placebo (Drug)
PRX019, single dose
Experimental
Specified dose on specified days
干预措施: PRX019 (Drug)
PRX019, multiple dose
Experimental
Specified dose on specified days
干预措施: PRX019 (Drug)
结局指标
主要结局
Number of participants with adverse events
时间窗: Up to 6 months
Number of participants with clinical laboratory assessment abnormalities
时间窗: Up to 6 months
次要结局
- Maximum observed plasma concentration (Cmax)(Up to 6 months)
- Time to the maximum measured plasma concentration (Tmax)(Up to 6 months)
- Area under the concentration-time curve from time 0 through the intended dosing interval (AUCͳ)(Up to 6 months)
- Terminal elimination half-life in plasma (t1/2)(Up to 6 months)
- Maximum observed plasma concentration at steady state (Cmax,ss)(Up to 6 months)
- Area under the concentration-time curve from time 0 through the intended dosing interval at steady state (AUCͳ,ss)(Up to 6 months)
研究者
研究点 (2)
Loading locations...
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