NCT00584584已完成2 期
A Proof of Concept Study of the Effects of QAX576 (an Interleukin-13 Monoclonal Antibody) on Allergic Inflammation Following Out of Allergy Season Repeated Nasal Allergen Challenge in Subjects With Seasonal Allergic Rhinitis Sensitive to Timothy Grass Pollen
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Markers of allergic inflammation in the nose measured over 5-8 days post-dose.
研究概览
简要总结
This study will investigate whether a single dose QAX576 (an interleukin-13 monoclonal antibody) gives protection against a model of hayfever
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 否
入选标准
- •History of allergic rhinitis.
排除标准
- •Respiratory disease other than mild intermittent asthma.
- •Received immunotherapy in past 3 years.
- •History of clinically significant drug allergy.
- •History of clinical schistosomiasis or travel within 6 months prior to or following study to an area with endemic schistosomiasis.
- •History of exposure to human therapeutic antibodies, immunoglobulins or other plasma products.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
1
Experimental
干预措施: QAX576 (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Markers of allergic inflammation in the nose measured over 5-8 days post-dose.
时间窗: throughout the study
次要结局
- - Nasal symptom scores over 5-8 days post-dose. - Blood levels of QAX576 to 3 months post-dose. - Marker of allergic inflammation in blood to 3 months post-dose.(throughout the study)
研究者
研究点 (1)
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