NCT05846009已完成1 期
A Phase I, First-in-human, Two-part, Randomized, Placebo-controlled, Double-blind, Single and Repeated Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous Doses of SAR442501 in Healthy Adult Subjects
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events/treatment-emergent adverse events/adverse events of special interest
研究概览
简要总结
The purpose of the first-in-human (FIH) study is to obtain safety, tolerability, and pharmacokinetic information on SAR442501 in a healthy adult volunteer population using an integrated single ascending dose (SAD)-multiple ascending dose (MAD) parallel cohort study design.
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
- Double (Participant, Investigator)
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
- •Male and female participants, between 18 and 45 years of age, inclusive.
- •Body weight between 50.0 and 85.0 kg, inclusive, body mass index between 18.0 and 32.0 kg/m2, inclusive.
- •Certified as healthy by a comprehensive clinical assessment.
- •Having given written informed consent prior to undertaking any study-related procedure.
排除标准
- •Any history or presence of clinically relevant medical status as per the protocol.
- •Any participant who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development.
- •The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.
研究组 & 干预措施
SAR442501
Experimental
干预措施: SAR442501 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with adverse events/treatment-emergent adverse events/adverse events of special interest
时间窗: Baseline up to end of study (EOS) (Day 89)
次要结局
- Assessment of PK parameter: Partial area under the serum concentration time curve (AUC)(Baseline up to EOS (Day 89))
- Assessment of PK parameter: Maximum observed concentration (Cmax)(Baseline up to EOS (Day 89))
- Immunogenicity: evaluate the presence of anti-SAR442501 antibodies(Baseline up to EOS (Day 89))
- Assessment of PK parameter: First time to reach Cmax (tmax)(Baseline up to EOS (Day 89))
研究者
研究点 (1)
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