NCT00528099已完成1 期
Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IMA-026 Administered Subcutaneously or Intravenously to Healthy Japanese Male Subjects
Wyeth is now a wholly owned subsidiary of Pfizer1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2007年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To assess the safety and PK profile of IMA-026 administered as single ascending subcutaneous or intravenous doses.
研究概览
简要总结
To assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of ascending, single subcutaneous or intravenous doses of IMA-026 in healthy Japanese male subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Men ages 20 to 40 years, inclusive, at screening
- •Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight > 45 kg
- •Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vitals signs, and 12 lead ECG.
排除标准
- 未提供
结局指标
主要结局
To assess the safety and PK profile of IMA-026 administered as single ascending subcutaneous or intravenous doses.
时间窗: 6 months
次要结局
未报告次要终点
研究者
研究点 (1)
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