NCT01448317已完成1 期
A Randomized, Double-Blind, Placebo-Controlled, Ascending Single-Dose Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered SAR236553 in Japanese Healthy Male 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
- 32
- 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 ascending single doses of subcutaneously (SC) administered alirocumab (SAR236553/REGN727) in Japanese healthy male subjects.
Secondary Objectives:
- To assess the pharmacodynamics effect of a single SC dose of alirocumab on serum low-density lipoprotein cholesterol (LDL-C) and other lipids and apolipoproteins such as total cholesterol, high-density lipoprotein cholesterol (HDL-C), non-high-density lipoprotein cholesterol, very low-density lipoprotein cholesterol, Triglycerides, Apolipoprotein B, Apolipoprotein A1 and Lipoprotein(a).
- To assess the Pharmacokinetic profile of a single SC dose of alirocumab.
- To assess the immunogenicity of a single SC dose of alirocumab.
详细描述
4 sequential dose cohorts. Single dose followed by a total observation period of 15 weeks (106 days) for each participant.
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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subject, between 20 and 65 years inclusive.
- •Body weight between 50.0 and 95.0 kg inclusive, body mass index between 18.0 and 30.0 kg/m² inclusive.
- •Serum LDL-C levels >100 mg/dL
排除标准
- •Subject indicated for the use of statins according to criteria in Adult Treatment Panel (ATP) III Guidelines as updated in 2004
- •Significant concomitant illness or history of significant illness such as cardiac, renal, neurological, endocrinological, dermatological, metabolic or lymphatic disease, or any other illness or condition that would adversely affect the subject's participation in this study.
- •History or presence of drug or alcohol abuse
- •Smoking more than 5 cigarettes or equivalent in any 24 hour period.
- •Any medication (including St John's Wort) within 14 days before the inclusion or within 5 times the elimination half-life or pharmacodynamic (PD) half-life of that drug, whichever the longest; any vaccination within the last 28 days.
- •Positive reaction to any of the following tests: hepatitis B surface (HBs Ag) antigen, anti-hepatitis B core antibodies (anti-HBc Ab), anti-hepatitis C virus (anti-HCV) antibodies, human immunodeficiency virus (HIV) antigen and antibodies, syphilis.
- •Elevated cholesterol due to a secondary cause such as hypothyroidism or alcohol.
- •Presence or history of drug hypersensitivity
- •Initiation of a new exercise routine or major change to a previous exercise routine within 4 weeks prior to Screening.
- •Initiation of a new diet or major change to a previous diet within 4 weeks prior to Screening.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
Cohort 2
Experimental
Alirocumab dose 2 versus placebo
干预措施: Placebo (Lyophilized formulation) (Drug)
Cohort 1
Experimental
Alirocumab dose 1 versus placebo
干预措施: Alirocumab (Lyophilized formulation) (Drug)
Cohort 1
Experimental
Alirocumab dose 1 versus placebo
干预措施: Placebo (Lyophilized formulation) (Drug)
Cohort 2
Experimental
Alirocumab dose 2 versus placebo
干预措施: Alirocumab (Lyophilized formulation) (Drug)
Cohort 3
Experimental
Alirocumab dose 3 versus placebo
干预措施: Alirocumab (Lyophilized formulation) (Drug)
Cohort 3
Experimental
Alirocumab dose 3 versus placebo
干预措施: Placebo (Lyophilized formulation) (Drug)
Cohort 4
Experimental
Alirocumab dose 4 versus placebo
干预措施: Alirocumab (Solution) (Drug)
Cohort 4
Experimental
Alirocumab dose 4 versus placebo
干预措施: Placebo (Solution) (Drug)
结局指标
主要结局
Number of participants with Adverse Events
时间窗: 106 days
次要结局
- Change in serum Low-Density Lipoprotein Cholesterol (LDL-C) from baseline to each visit.(106 days)
- Change in ApolipoproteinB, ApolipoproteinA1 and Lipoprotein(a) from baseline to each visit.(106 days)
- Change in Total Cholesterol (T-C), High-Density Lipoprotein Cholesterol (HDL-C), Very Low-Density Lipoprotein Cholesterol (VLDL-C) and Triglycerides (TG) from baseline to each visit.(106 days)
研究者
研究点 (1)
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