A Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability and Pharmacokinetics of Ascending Single Subcutaneous Doses of SAR231893/REGN668 in Healthy Japanese Adult Male Subjects
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 subjects with standard safety assessments (adverse events, physical examinations, 12 lead ECGs, vital signs and laboratory tests)
研究概览
简要总结
Primary Objective:
Assess the safety and tolerability of SAR231893 (REGN668) after ascending single subcutaneous (SC) doses in healthy Japanese adult male subjects
Secondary Objectives:
Assess the following parameters after ascending single SC doses in healthy Japanese adult male subjects
- The pharmacokinetics of SAR231893 (REGN668)
- The immunogenicity of SAR231893 (REGN668)
- Exploratory analyses of the pharmacodynamics of SAR231893 (REGN668)
详细描述
Total duration of the study period per subject is 11 weeks broken down as follows:
Screening period = 2 to 21 days Treatment period = 57 days, including 1 treatment day
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 45 Years（Adult）
- 性别
- Male
- 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
SAR231893 (REGN668), Dose Level 4
Dose Level 4
干预措施: SAR231893 (REGN668) (Drug)
Placebo
Placebo
干预措施: placebo (Drug)
SAR231893 (REGN668), Dose Level 1
Dose Level 1
干预措施: SAR231893 (REGN668) (Drug)
SAR231893 (REGN668), Dose Level 2
Dose Level 2
干预措施: SAR231893 (REGN668) (Drug)
SAR231893 (REGN668), Dose Level 3
Dose Level 3
干预措施: SAR231893 (REGN668) (Drug)
结局指标
主要结局
Number of subjects with standard safety assessments (adverse events, physical examinations, 12 lead ECGs, vital signs and laboratory tests)
时间窗: Up to 57 days
次要结局
- Pharmacokinetics: Serum concentrations of SAR231893 (REGN668) over time(Up to 57 days)
- Pharmacodynamics: Serum total Immunoglobulin E (IgE) and Thymus and activation regulated chemokine (TARC) over time(Up to 57 days)