NCT01443650已完成1 期
A Randomized Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics After Different Single-Dose Subcutaneous Treatments of SAR236553/REGN727 in Healthy 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
- 36
- 试验地点
- 1
- 主要终点
- Pain using Present Pain Intensity (PPI) verbal questionnaire and Visual Analog Scale (VAS)
研究概览
简要总结
Primary Objective:
Injection Site Tolerability
Secondary Objectives:
- To assess the safety profile of alirocumab SAR236553 (REGN727)
- To assess the pharmacokinetic-pharmacodynamic relationship of alirocumab SAR236553 (REGN727)
详细描述
Total duration for each subject (not including screening) will be approximately 85 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
- Double (Participant, Investigator)
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 SAR236553 (REGN727) (Formulation A x 1)
Experimental
A single subcutaneous injection of Formulation A
干预措施: alirocumab SAR236553 (REGN727) (Drug)
alirocumab SAR236553 (REGN727) (Formulation B x 1)
Experimental
A single subcutaneous injection of Formulation B
干预措施: alirocumab SAR236553 (REGN727) (Drug)
alirocumab SAR236553 (REGN727) (Formulation A x 2)
Experimental
2 single subcutaneous injections of Formulation A
干预措施: alirocumab SAR236553 (REGN727) (Drug)
结局指标
主要结局
Pain using Present Pain Intensity (PPI) verbal questionnaire and Visual Analog Scale (VAS)
时间窗: 15 days
Erythema at injection site by measuring diameter and qualitative assessment
时间窗: 15 days
Edema at injection site by measuring diameter and qualitative assessment
时间窗: 15 days
次要结局
- Assessment of PK parameter - time to maximum concentration (tmax)(Up to 85 days)
- Pharmacodynamics: Change in LDL-C from baseline(Up to 85 days)
- Number of participants with Adverse Events(Up to 85 days)
- Assessment of PK parameter - maximum concentration (Cmax)(Up to 85 days)
- Assessment of PK parameter - area under curve (AUC)(Up to 85 days)
- Assessment of PK parameter - area under curve versus time curve (AUC0-D29)(Zero to Day 29)
- Assessment of PK parameter - plasma concentration on Day 29 (C D29)(Day 29)
- Assessment of PK parameter - terminal elimination half-life (t1/2z)(Up to 85 days)
研究者
研究点 (1)
Loading locations...
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