NCT00688779已完成1 期
A Double Blind, Placebo Controlled, Randomised, First Time In Man. Study to Investigate the Tolerability, Safety, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of AZD8848 Administered Intranasally to Healthy Male Volunteers and Seasonal Allergic Rhinitis Male Patients Out Of Season
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
- AstraZeneca
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Incidence/nature of adverse events, 12-lead ECG, pulse, BP, body temperature, spirometry
研究概览
简要总结
Investigate safety/tolerability after a single dose intranasal administration of AZD8848 comparator placebo to healthy male volunteers and seasonal allergic rhinitis male patients out of season
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •History of birch and/or timothy grass pollen induced seasonal allergic rhinitis for at least the previous 2 years
- •Body mass index (BMI) between 19 and 30 kg/ m2 and a weight between 50 and 100 kg
- •No clinically relevant abnormal findings
排除标准
- •Acute illness which requires medical intervention
- •Definite or suspected personal history of adverse drug reactions or drug hypersensitivity
- •Clinical relevant disease or disorder (past or present)
- •A history of asthma
研究组 & 干预措施
1
Experimental
干预措施: AZD8848 (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence/nature of adverse events, 12-lead ECG, pulse, BP, body temperature, spirometry
时间窗: During the study
次要结局
- Clinical chemistry, haematology, urinalysis(During the study)
- Nasal symptoms and peak nasal inspiratory flow(During the study)
- Pharmacokinetics(During the study)
- Biomarkers nasal lavage and blood(During the study)
研究者
研究点 (1)
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