NCT04521738已完成1 期
A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Subcutaneous Doses of SAR441255 in Lean to Overweight Adult Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
Primary Objective:
To assess the safety and tolerability of SAR441255 after ascending single subcutaneous (SC) doses
Secondary Objectives:
To assess the pharmacokinetic parameters of SAR441255 in plasma after ascending single SC doses
To assess the pharmacodynamic effects on glycemic parameters (fasting and postprandial glucose, C-peptide and insulin)
详细描述
Study duration per participant is approximately 8 weeks including a 21-day screening and baseline phase, a 4-day treatment phase and a 28-day follow up period after dosing.
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 55 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
SAR441255
Experimental
Single dose, subcutaneous, escalating dose
干预措施: SAR441255 (Drug)
Placebo
Placebo Comparator
Single dose, subcutaneous, matched volume
干预措施: placebo (Drug)
结局指标
主要结局
Number of participants with adverse events
时间窗: Screening to Day 28
次要结局
- Assessment of pharmacokinetic (PK) parameter: Cmax(Baseline to 96 hrs)
- Assessment of PK parameter: AUC(Baseline to 96 hrs)
- Assessment of PK parameter: tmax(Baseline to 96 hrs)
- Assessment of pharmacodynamics (PD): glucose profile(Baseline to 24 hrs)
- Assessment of PD: insulin profile(Baseline to 24 hrs)
- Assessment of PD: C-peptide profile(Baseline to 24 hrs)
研究者
研究点 (1)
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