NCT00447681已完成1 期
Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetiks, and Pharmacodynamics of ILV-094 Administered Intravenously and One Dose of ILV-094 Administered Subcutaneously to Healthy 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 56 人开始时间: 2006年12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
- 56
- 试验地点
- 1
- 主要终点
- To evaluate the safety, tolerability, pharmacokinetics and pharmcodynamics
研究概览
简要总结
This a randomized, double-blind placebo-controlled inpatient/outpatient, sequential group study of ascending single IV doses of ILV-094, an investigational drug, administered to healthy subjects. In addition, there will be one sub-cutaneous dose cohort, which will follow the 25 mg IV dose.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects (Men or women of nonchildbearing potential ), aged 18 to 50 years.
- •Body mass index in the range of 18 to 30 Kg/m2 and body weight greater than 50 Kg.
- •Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram.
排除标准
- 未提供
结局指标
主要结局
To evaluate the safety, tolerability, pharmacokinetics and pharmcodynamics
次要结局
未报告次要终点
研究者
研究点 (1)
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