NCT00929968已完成2 期
A Randomized, Double-blind, Placebo and Calibrator Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Intravenous Doses of VAK694 in Subjects With Seasonal Rhinitis During Natural Exposure to Allergen
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- To assess the safety and tolerability of prolonged administration of multiple intravenous doses of VAK694 as well as the preliminary efficacy of multiple intravenous doses of VAK694 in atopic subjects
研究概览
简要总结
This study will assess the safety and tolerability of multiple doses of VAK694 as well as change in symptoms and biomarkers in patients with seasonal allergic rhinitis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female subjects between ages of 18 to 60 in good health
- •History of atopy for at least 2 years and positive skin prick test to ragweed allergen
- •Exclusion criteria:
- •History of asthma treated with corticosteroids
- •Smokers with a smoking history of > 10 pack/years or smoking in the past year
- •History of chronic obstructive pulmonary disease
- •Other protocol-defined inclusion/exclusion criteria may apply
排除标准
- 未提供
研究组 & 干预措施
Placebo to VAK694
Placebo Comparator
干预措施: Placebo (Biological)
VAK694
Experimental
干预措施: VAK694 (Biological)
Fluticasone propionate
Active Comparator
干预措施: Fluticasone (Drug)
结局指标
主要结局
To assess the safety and tolerability of prolonged administration of multiple intravenous doses of VAK694 as well as the preliminary efficacy of multiple intravenous doses of VAK694 in atopic subjects
时间窗: 12 weeks
次要结局
- Change in serum levels of total and antigen specific IgE and total and antigen specific IgG(12 weeks)
- Changes in rhinitis visual-analogue score and the use of symptom relief during both the peak and entire allergy season.(12 weeks)
- Changes in biomarkers of immunomodulation(12 weeks)
- To evaluate pharmacokinetics of multiple intravenous doses of VAK694 in atopic subjects(12 weeks)
- Immunogenicity of multiple intravenous doses of VAK694(12 weeks)
研究者
研究点 (2)
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