NCT01166698已完成1 期
A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group, 2-part Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Inhaled Doses of AZD9819 in Healthy 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
- 100
- 试验地点
- 1
- 主要终点
- Safety variables (ECG variables, adverse events, blood pressure, pulse, body temp, safety lab)
研究概览
简要总结
The purpose of the study is to assess safety and tolerability of AZD9819 following inhaled administration of single and multiple increasing doses, and to estimate the maximum dose that is tolerated in healthy people.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of signed and dated, written informed consent prior to any study specific procedures
- •Healthy male and female (non-child bearing potential) subjects aged 18 to 50 years with suitable veins for cannulation or repeated venepuncture.
- •Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
排除标准
- •Any clinically significant disease or disorder
- •Any clinically significant abnormalities at screening examination
- •Use of any prescribed or non-prescribed medication
研究组 & 干预措施
AZD9819
Experimental
Inhaled suspension
干预措施: AZD9819 (Drug)
Placebo
Placebo Comparator
Inhaled suspension
干预措施: Placebo (Drug)
结局指标
主要结局
Safety variables (ECG variables, adverse events, blood pressure, pulse, body temp, safety lab)
时间窗: Frequent safety measurements during the study from screening period to follow-up
次要结局
- Pharmacokinetic variables of AZD9819 by assessment of drug concentrations in plasma(Multiple PK blood samples from pre-dose until 96 hours post last dose)
研究者
研究点 (1)
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