NCT00847249已完成1 期
A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Inhaled AZD9164 After Single Ascending Doses in Healthy Male 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
- AstraZeneca
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab)
研究概览
简要总结
The aims of the study are to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of AZD9164 following single ascending dose administrations to healthy male subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Provision of signed, written and dated informed consent prior to any study specific procedures
- •Have a body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
- •Be non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for >6 months prior to study start
排除标准
- •Any clinically significant disease or disorder
- •Any clinically significant abnormalities at screening examinations
- •Use of any prescribed or non-prescribed medication
研究组 & 干预措施
1
Experimental
Solution for nebulisation, inhaled
干预措施: AZD9164 (Drug)
2
Placebo Comparator
Solution for nebulisation, inhaled
干预措施: Placebo (Drug)
结局指标
主要结局
Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab)
时间窗: up to 48 hours post-dose.
次要结局
- Pharmacokinetics(up to 48 hours post-dose.)
- Local and extrapulmonary effects(up to 48 hours post-dose.)
研究者
研究点 (1)
Loading locations...
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