NCT00722501已完成1 期
Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ERB-257 Administered Intravenously as a 30-Minute Infusion 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 48 人开始时间: 2008年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- To evaluate the safety and tolerability of single ascending IV doses of ERB-257 administered to healthy subjects
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of ascending single IV doses of ERB-257 in healthy 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
- 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 men and women of non-childbearing potential between the ages of 18 and
- •Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight greater than or equal to 50 kg
- •Have a high probability for compliance with and completion of the study.
排除标准
- •Presence or history of any disorder that may prevent the successful completion of the study.
- •Acute disease state (eg, nausea, vomiting, fever, or diarrhea) within 7 days before study day 1.
研究组 & 干预措施
ERB-257
Active Comparator
7 IV single doses of ERB-257 will be given to 6 healthy subjects per group - 1,4, 15, 45, 90, 180, and 300 mg
干预措施: ERB-257 (Drug)
placebo
Placebo Comparator
2 placebo subjects per group
干预措施: placebo (Other)
结局指标
主要结局
To evaluate the safety and tolerability of single ascending IV doses of ERB-257 administered to healthy subjects
时间窗: 4 days per group
次要结局
- To evaluate the pharmacokinetics of single ascending IV doses of ERB-257 administered to healthy subjects(4 days per group)
研究者
研究点 (1)
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