NCT01066611已完成1 期
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Two-Period Crossover Study to Investigate the Safety of CAL-263 in Allergic Rhinitis Subjects and Effects on the Response to Environmental Chamber Allergen Challenge
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
- 48
- 试验地点
- 1
- 主要终点
- Evaluate the safety of CAL-263 in allergic rhinitis subjects
研究概览
简要总结
The purpose of this study is to determine the safety and effect of CAL-263 in subjects with allergic rhinitis.
详细描述
A Phase I, randomized, double-blind crossover study of CAL-263, an oral inhibitor of PI3K delta, in patients with allergic rhinitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Age >18 and <55 years
- •Has a history of seasonal allergic rhinitis for at least 2 years
- •Has sensitivity to grass pollen demonstrated by a positive response to skin prick testing
- •Has a positive Radio Allergen Sorbent Test (class 2 or greater) for grass pollen during the previous 12 months or at screening
- •Is otherwise healthy
- •Is able to provide written informed consent
排除标准
- •Is a female of childbearing
- •History of chronic nasal or upper respiratory tract symptoms or disorders other than allergic rhinitis
- •History of nonallergic rhinitis, chronic sinusitis or severe asthma
- •Has a nasal condition likely to affect the outcome of the study
- •Is currently taking regular medication, whether prescribed or not, including corticosteroids, vitamins, macrolides, anti-fungal agents and herbal remedies
- •Has taken a prohibited medication within the specified interval prior to Visit 1
研究组 & 干预措施
1
Active Comparator
CAL-263
干预措施: CAL-263 (Drug)
2
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Evaluate the safety of CAL-263 in allergic rhinitis subjects
时间窗: 46 days
次要结局
- Determine the efficacy of CAL-263 on total nasal symptom scores following an allergen challenge in allergic rhinitis subjects(7 days)
研究者
研究点 (1)
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