A Study Of The Effects Of OC000459 On Responses To Allergen Challenge In The Vienna Chamber In Subjects Known To Suffer From Grass Pollen Induced Allergic Rhinitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Oxagen Ltd
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Efficacy of OC00045 on response to allergen challenge as measured by change in Total Nasal Symptom Score
研究概览
简要总结
The study will assess the efficacy of OC000459 200 mg twice daily orally in comparison to placebo when subjects are challenged in the Vienna Challenge Chamber for 6 hours. This is a randomised, double blind, placebo controlled, two way crossover evaluation. There will be a screening period of up to three weeks and a washout period of at least one week between the two treatment periods. There will be a follow up one to three weeks after the last dose of study drug.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males aged 18 to 50 years with a history of symptoms of grass pollen related allergic rhinitis within the previous two years.
- •Subjects must be free from significant cardiac, pulmonary, gastrointestinal, hepatic, renal, haematological, neurological and psychiatric disease as determined by history, physical examination and screening investigations.
- •FEV1 within normal limits (≥90% of predicted).
- •Atopy defined by a positive cutaneous response to mixed grass pollen within the last 12 months or at screening.
- •Asymptomatic at screening
- •Non smokers for at least the past 12 months
排除标准
- •Medical conditions likely to affect the outcome of the study.
- •Nasal conditions likely to affect the outcome of the study, i.e. nasal septal perforations, nasal polyps, sinus disease, chronic nasal obstruction, or other nasal diseases.
- •Presence of any respiratory disease other than a history of mild stable asthma not requiring treatment and associated with normal lung function
- •Immunotherapy treatment course including inhaled or local corticosteroids in the past 28 days.
研究组 & 干预措施
OC000459
干预措施: OC000459 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Efficacy of OC00045 on response to allergen challenge as measured by change in Total Nasal Symptom Score
时间窗: 8 days
To assess the efficacy of OC000459 200 mg twice daily orally in comparison to placebo when subjects are challenged in the Vienna Challenge Chamber for 6 hours as shown by the effect on Total Nasal Symptom Score
次要结局
- OC000459 safety as determined by adverse events, laboratory parameters, lung function and vital signs(8 days)
- OC000459 plasma concentration (Cmin)(8 days)