NCT00953888已完成1 期
A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AZD5069 After Single Ascending Doses in Healthy Male and/or 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
- 203
- 试验地点
- 1
- 主要终点
- Safety and tolerability of AZD5069 assessing vitals signs (blood pressure, pulse rate,body temperature), ECG,laboratory variables (including high sensitivity C-reactive protein, circulating neutrophils), continuous cardiac monitoring using telemetry.
研究概览
简要总结
The purpose of this study is to determine how well tolerated and safe AZD5069 is at different dose levels in healthy male and/or females. The study will also investigate how quickly AZD5069 is absorbed into and cleared by the body.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of signed and dated, written informed consent
- •Healthy male or female (of non child bearing potential) caucasian subjects aged 18 to 65 years with suitable veins for cannulation or repeated venepuncture
- •Body mass index of between 18 and 30 kg/m2 inclusive
排除标准
- •Subjects must not have any clinically significant disease or disorder, which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results, or the subjects ability to participate in the study
- •Subjects must not have any history of gastrointestinal, liver or kidney disease, or any other condition known to interfere with how drugs are absorbed, used or eliminated by the body
- •Subjects must not have had any significant illness or medical/surgical procedures or injuries with 4 weeks of administration of the investigational product
研究组 & 干预措施
Active
Experimental
AZD5069 oral solution
干预措施: AZD5069 (Drug)
Placebo
Placebo Comparator
Placebo oral solution
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability of AZD5069 assessing vitals signs (blood pressure, pulse rate,body temperature), ECG,laboratory variables (including high sensitivity C-reactive protein, circulating neutrophils), continuous cardiac monitoring using telemetry.
时间窗: Baselines assessments at Visit 1 (enrolment). Assessments pre-dose at Visit 2 and at protocol defined time-points post-dose. Follow up assessments at Visit 3.
次要结局
- Pharmacokinetic profile: concentration of AZD5069 in blood(Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose.)
- Pharmacodynamic profile: assessment of ex vivo GROa stimulated CD11b expression on neutrophils in whole blood(Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 48 hours post-dose.)
- Measurement of the effect of AZD5069 on circulating neutrophils(Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose.)
研究者
研究点 (1)
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