NCT00563810已完成1 期
An Ascending Multiple Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of MYO-029 Administered Intravenously as a 30-Minute Infusion to Healthy Subjects
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 72 人开始时间: 2004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
- 72
- 主要终点
- To assess safety and tolerability.
研究概览
简要总结
This is a multiple dose study assessing the safety, tolerability, pharmacokinetics and pharmacodynamics of an investigational new drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men aged 18 to 45 years inclusive on study day
- •Elderly men and women aged 65 to 80 years inclusive on study day
- •Women must be postmenopausal for > or = 1 year (with estradiol < 25 pg/mL and an FSH > 40 mIU/mL).
- •Healthy as determined by the investigator on the basis of medical history, physical examination, vital signs, clinical laboratory test results, and 12-leave electrocardiogram.
- •Elderly subjects may have stable, nonclinically significant abnormalities on physical examination, and laboratory evaluation.
- •Non-smoker.
排除标准
- 未提供
结局指标
主要结局
To assess safety and tolerability.
次要结局
未报告次要终点
研究者
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