NCT00411814已完成1 期
A Dose-escalating Study of the Safety and Pharmacokinetics of GSK679586A in Healthy Volunteers and Mild Asthmatics.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Safety and tolerability in healthy volunteers.Assessed using clinical safety assessments and blood and urine analysis
研究概览
简要总结
This is a two part study. Part I is designed to test single doses of GSK678586A in healthy volunteers. Part II is designed to test repeat doses (two doses) of GSK679586A in patients with mild asthma. Both parts are designed to investigate the safety, tolerability and the way the body absorbs GSK679586A when given by intravenous infusion (through a vein in your arm).
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
Placebo Comparator
Saline
干预措施: Placebo (Drug)
Active
Active Comparator
GSK679586
干预措施: GSK679586 (Drug)
结局指标
主要结局
Safety and tolerability in healthy volunteers.Assessed using clinical safety assessments and blood and urine analysis
时间窗: Throughout the study
Safety and tolerability in mild asthmatics.Assessed using clinical safety assessments and blood and urine analysis.
时间窗: Throughout the study
次要结局
- Blood sampling(Throughout the study)
- Effects on blood and lung function.(Throughout the study)
- Lung function(Throughout the study)
- Plasma levels of GSK679586A to determine pharmacokinetic parameters(Throughout the study)
- serum antibodies to GSK679586A(Throughout the study)
研究者
研究点 (1)
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