A Randomized, Double-Blind, Placebo-Controlled, Ascending Single-Dose Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered Alirocumab in Chinese Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Incidence of adverse events based on standard and systematic assessment including physical examinations, 12 lead ECGs, vital signs and laboratory tests
研究概览
简要总结
Primary Objective:
To assess the safety and tolerability of ascending single SC doses of alirocumab in Chinese healthy subjects.
Secondary Objectives:
- To assess the pharmacokinetic profile of a single SC dose of alirocumab.
- To assess the pharmacodynamic effect of a single SC dose of alirocumab on low-density lipoprotein cholesterol (LDL-C) and other lipid parameters.
- To assess the immunogenicity of a single SC dose of alirocumab.
详细描述
Ascending dose design includes 3 dose levels. Tolerance data up to at least 14 days post dosing from at least 6 subjects of the previous cohort will be reviewed before proceeding with a next dose. Total duration of the study per subject is approximately 15 weeks (including screening period).
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 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
Alirocumab
Subcutaneous injection of a single dose of alirocumab, dose level according to ascending dose design
干预措施: alirocumab SAR236553 (REGN727) (Drug)
Placebo
Subcutaneous injection of a single dose of matching placebo
干预措施: placebo (Drug)
结局指标
主要结局
Incidence of adverse events based on standard and systematic assessment including physical examinations, 12 lead ECGs, vital signs and laboratory tests
时间窗: Up to 12 weeks
Incidence of injection site reactions
时间窗: Up to 4 days
次要结局
- Change from baseline in LDL-C(Up to 12 weeks)
- Change from baseline in other lipid parameters(Up to 12 weeks)
- Pharmacokinetics: Assessment of serum concentrations of alirocumab(Up to 12 weeks)
- Pharmacokinetics: Assessment of serum concentrations of PCSK9(Up to 12 weeks)