NCT01037504已完成1 期
Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Inhaled AZD5423 After Administration of Multiple Ascending Doses for 14 Days in Healthy Male and Female 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
- 27
- 试验地点
- 1
- 主要终点
- Safety variables: adverse events
研究概览
简要总结
The aim of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD5423 following multiple ascending dose administrations in healthy male and female 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
- 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
- •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
A
Experimental
Drug: AZD5423
干预措施: AZD5423 (Drug)
B
Placebo Comparator
Drug: Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Safety variables: adverse events
时间窗: Assessment taken at screening visit, defined timepoints pre-dose and post-dose during treatment periods and follow-up visit. Volunteers will be monitored throughout the study for adverse events.
次要结局
- Pharmacokinetics profile: concentration of AZD5423 in plasma(Samples taken at defined timepoints pre-dose and post-dose during treatment periods. Samples taken at approx. 39 timepoints.)
- Investigation of PD effects(Samples taken at screening visit, defined timepoints pre-dose and post-dose during treatment periods and follow-up.)
研究者
研究点 (1)
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