NCT00620230已完成1 期
A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetic Profile and Pharmacodynamic Effect of Single and Multiple Doses of VAK694 in Healthy and Atopic Subjects
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
- Novartis
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Routine safety observations and pharmacokinetic measurements
研究概览
简要总结
This study will evaluate the safety and tolerability of single and multiple doses of VAK694 in healthy volunteers and otherwise healthy volunteers with a history of allergies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •History of allergic rhinitis (Part 2 only)
排除标准
- •Very low or high body weight
- •Heavy or recent smoker
- •Exposure to human monoclonal antibodies
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
1
Experimental
干预措施: NVP-VAK694 (Drug)
2
Placebo Comparator
干预措施: NVP-VAK694 (Drug)
结局指标
主要结局
Routine safety observations and pharmacokinetic measurements
时间窗: throughout the study
次要结局
- Routine safety observations and pharmacokinetic measurements(throughout the study)
研究者
研究点 (1)
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