NCT00920933已完成1 期
Double Blind, Placebo Controlled, Parallel Group Study With an Open Label Reference Arm to Assess the Effects of Intravenously Administered AIN457 on Ozone Induced Neutrophilia Compared to Placebo & Oral Corticosteroid in Healthy Volunteers
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
- 24
- 试验地点
- 1
- 主要终点
- Total neutrophil cell count in 106/mL in induced sputum
研究概览
简要总结
This study will assess the ability of AIN457 to attenuate the increase in airway neutrophils that is seen following ozone exposure. Healthy subjects will be treated with AIN457, placebo, or oral corticosteroid and the response to a subsequent ozone exposure will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（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
AIN457
Experimental
干预措施: AIN457 (Biological)
Placebo
Placebo Comparator
干预措施: Placebo (Other)
oral corticosteroid
Active Comparator
干预措施: prednisolone (Drug)
结局指标
主要结局
Total neutrophil cell count in 106/mL in induced sputum
时间窗: Day 16
次要结局
- Percentage neutrophil cell count in induced sputum(Day 16)
- Serum total IL-17A(Day 1- Day 120)
- Safety and tolerability. Safety assessments will include vital signs, electrocardiograms (ECG), spirometry, pulse oximetry, immunogenicity and adverse events (AEs)(Day 1-Day 120)
- Airway function (FEV1, FVC, and FEF25-75)(4h, 24h, and 48h after the start of the ozone exposure)
- Serum AIN457 pharmacokinetics (PK)(Day1-Day 120)
研究者
研究点 (1)
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