NCT00339872已完成1 期
Randomized, Double-Blind, Placebo-Controlled, Sequential-Group, Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IMA-638 Administered Subcutaneously and Intravenously to Subjects With Asthma
Wyeth is now a wholly owned subsidiary of Pfizer1 个研究点 分布在 1 个国家开始时间: 2006年2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
- 试验地点
- 1
- 主要终点
- Safety will be measured by evaluating physical examinations, spirometry, vital signs, electrocardiograms (ECGs), and clinical laboratory test results.
研究概览
简要总结
The purpose of this study is to evaluate the safety of, and blood drug levels for, single, ascending doses of IMA-638 in mild to moderate asthma 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
- Diagnostic
- 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
- 否
入选标准
- •Men and women of non-childbearing potential with mild to moderate asthma as defined by forced expiratory volume in 1 second (FEV1) greater than 70% predicted.
- •Well controlled asthma, as exhibited by completion of asthma questionnaire.
- •Otherwise healthy, except for asthma.
排除标准
- 未提供
结局指标
主要结局
Safety will be measured by evaluating physical examinations, spirometry, vital signs, electrocardiograms (ECGs), and clinical laboratory test results.
次要结局
- Drug levels in the blood and associated biomarkers will be evaluated.
研究者
研究点 (1)
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