A Randomized, Partial Blind, 3 Parallel Groups Study of the Pharmacodynamic Profile of SAR236553 (REGN727) Administered as Multiple Subcutaneous Doses, Either Alone or on Top of Ezetimibe or Fenofibrate Administered as Multiple Oral Doses in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 79
- 试验地点
- 2
- 主要终点
- Assessment of the effect of alirocumab on LDL-C
研究概览
简要总结
Primary Objective:
To assess the pharmacodynamic profile of alirocumab (SAR236553/REGN727) administered either alone or on top of ezetimibe or fenofibrate, based on low-density lipoprotein -cholesterol (LDL-C).
Secondary Objectives:
- To assess the pharmacodynamic profile of alirocumab administered either alone or on top of ezetimibe or fenofibrate, based on other lipid parameters.
- To assess the pharmacokinetic profile of alirocumab administered either alone or on top of ezetimibe or fenofibrate.
详细描述
Total duration of the study per subject (excluding screening) is about 22 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Alirocumab + Ezetimibe Placebo
Subcutaneous (SC) injections of alirocumab added to oral administration of ezetimibe placebo
干预措施: Alirocumab (Drug)
Alirocumab + Ezetimibe Placebo
Subcutaneous (SC) injections of alirocumab added to oral administration of ezetimibe placebo
干预措施: Ezetimibe Placebo (Drug)
Alirocumab + Ezetimibe
Subcutaneous (SC) injections of alirocumab added to oral administration of ezetimibe
干预措施: Alirocumab (Drug)
Alirocumab + Ezetimibe
Subcutaneous (SC) injections of alirocumab added to oral administration of ezetimibe
干预措施: Ezetimibe (Drug)
Alirocumab + Fenofibrate
Subcutaneous (SC) injections of alirocumab added to oral administration of fenofibrate
干预措施: Alirocumab (Drug)
Alirocumab + Fenofibrate
Subcutaneous (SC) injections of alirocumab added to oral administration of fenofibrate
干预措施: Fenofibrate (Drug)
结局指标
主要结局
Assessment of the effect of alirocumab on LDL-C
时间窗: Up to 18 weeks
次要结局
- Pharmacokinetics: Assessment of serum concentrations of proprotein convertase subtilisin kexin type 9 (PCSK9)(Up to 18 weeks)
- Assessment of the pharmacodynamic profile of alirocumab(Up to 18 weeks)
- Pharmacokinetics: Assessment of serum concentrations of alirocumab(Up to 18 weeks)