NCT00836914已完成1 期
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Two-Period Crossover Study to Investigate the Safety of CAL-101 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
- 41
- 试验地点
- 1
- 主要终点
- Evaluate the safety CAL-101 using adverse events, vital signs, clinical laboratory tests, spirometry and ECG
研究概览
简要总结
The purpose of this study is to determine the safety and effect of CAL-101 in subjects with allergic rhinitis.
详细描述
A Phase I, randomized, double-blind crossover study of CAL-101, an oral inhibitor of phosphatidylinositol 3-kinase (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 > or = 18 and < or = 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 (> or = class 2) for grass pollen during the previous 12 months or at screening
- •Is otherwise healthy, that is, free from clinically significant illness or disease as determined by medical history, physical examination and laboratory tests, including a normal 12-lead electrocardiogram (ECG)
- •Has no conditions which would make the subject unlikely to be able to remain in the allergen challenge chamber for 4 hours
- •Is available to complete all study procedures
- •Is able to provide written informed consent, including compliance with the requirements and restrictions listed in the consent form
排除标准
- •Is a female of childbearing potential (non-childbearing potential means documented surgery resulting in infertility or postmenopausal with no menses for at least 1 year)
- •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, i.e. nasal septal perforations, nasal polyps, sinus disease, chronic nasal obstruction, or other nasal diseases
- •Is currently taking regular medication, whether prescribed or not, including corticosteroids, vitamins, macrolides, anti-fungal agents and herbal remedies, e.g. St. John's Wort. Paracetamol (< or = 2g/day) and as needed use of short-acting B2-agonists are allowed.
- •Has taken a prohibited medication within the specified interval prior to Visit 1:
- •Corticosteroids (depot, 90 days; systemic, 30 days; dermatologic 14 days)
- •Chromones (14 days)
- •Antihistamines (nasal and long-acting oral, 10 days; shorting-acting oral, 2 days; ocular, 3 days)
- •Decongestants (3 days)
- •Leukotriene modifiers (10 days)
- •Anticholinergics (7 days)
- •Opthalmic nonsteroidal
- •anti-inflammatory drugs (3 days)
- •Nasal-ophthalmic wash solutions (12 hr)
- •Immunotherapy (12 hr)
- •Is currently being treated with a medication that induces or inhibits cytochrome P450 (CYP)3A
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
CAL-101
Active Comparator
干预措施: CAL-101 (Drug)
结局指标
主要结局
Evaluate the safety CAL-101 using adverse events, vital signs, clinical laboratory tests, spirometry and ECG
时间窗: Baseline to Day 35
次要结局
- Change from baseline in total nasal symptom score(Baseline to Day 35)
研究者
研究点 (1)
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