A Randomized, Double-blind, Parallel Design, Placebo-controlled Single and Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous and Subcutaneous Doses of SAR441344 in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Part 1: Number of participants with adverse event(AE)
研究概览
简要总结
Primary Objective is the tolerability and safety of ascending single and repeated intravenous infusion (IV) and/or subcutaneous (SC) administration of SAR441344
详细描述
The study duration of Part 1 is approximately 22 weeks, including a treatment period of 1 day; The study duration of Part 2 is approximately 26 weeks for each subject, including a treatment period of 29 days.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
placebo
matching placebo
干预措施: Keyhole limpet hemocyanin (Biological)
SAR441344
Single or multiple Ascending dose of SAR441344 Dose 1 administered intravenously and/or subcutaneously
干预措施: SAR441344 (Drug)
SAR441344
Single or multiple Ascending dose of SAR441344 Dose 1 administered intravenously and/or subcutaneously
干预措施: Keyhole limpet hemocyanin (Biological)
placebo
matching placebo
干预措施: placebo (Drug)
结局指标
主要结局
Part 1: Number of participants with adverse event(AE)
时间窗: From baseline to day 127
Number of participants with AE from baseline to day 127
Part 2: Number of participants with adverse event (AE)
时间窗: From baseline to day 155
Number of participants with AE from baseline to day 155
次要结局
- Assessment of PK parameter: Cmax(From Day 1 to Day 127 and to Day 155)
- Assessment of PK parameter: AUC0-tau(From day 1 to Day 155)
- Assessment of PK parameter: t1/2z(From Day 1 to Day 127 and Day 155)
- Assessment of PK parameter: AUClast(From Day 1 to Day 127)
- Assessment of anti-KLH IgG and IgM(From Day 1 to Day 127 and Day 155)
- Assessment of PK parameter: AUC(Area under the plasma concentration versus time curve extrapolated to infinity)
- Assessment of PK parameter: CL(/F)(Apparent total body clearance of a drug from the plasma)
- Assessment of PK parameter: CLss(/F)(Apparent total body clearance of a drug from the plasma)
- AE attributed to KLH immunization(From Day 1 to Day 127 and Day 155)
- Assessment of PK parameter: tmax(From Day 1 to Day 127 and Day 155)
- Assessment of PK parameter: Ctrough(From Day 1 to Day 155)
- Anti-SAR441344 antibodies(From Day 1 to Day 127 and Day 155)