NCT00970775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 Oral AZD2423 After Single Ascending Doses in Healthy Japanese Male and Non-Fertile Female Volunteers
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
- 32
- 试验地点
- 1
- 主要终点
- To asses the safety: Adverse events, vital signs, electrocardiograms (ECGs), laboratory variables.
研究概览
简要总结
This is a Phase I, single centre, randomised, double-blind, placebo-controlled, parallel group study to assess the safety, tolerability and pharmacokinetics of AZD2423 following single ascending dose administration to healthy Japanese 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Japanese male and non-fertile female subjects aged ≥20 to ≤55 years with suitable veins for cannulation or repeated venepuncture.
- •Body weight 45-90 kg and Body mass index (BMI) ≥18.0 and ≤27.0 kg/m2
- •Clinically normal physical findings including supine blood pressure, pulse rate, orthostatic blood pressure, ECG, and laboratory assessments in relation to age, as judged by the Investigator.
排除标准
- •History of 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 subject's ability to participate in the study.
- •Any clinically significant illness/infection or medical/surgical procedure or trauma, as judged by the Principal Investigator, within 3 months of the first administration of investigational product.
- •Frequent use of tobacco or other nicotine containing products. Frequent use is defined as smoking or consumption/intake of nicotine products more than two days per week during the last 12 weeks.
研究组 & 干预措施
1. AZD2423
Experimental
干预措施: AZD2423 (Drug)
2. Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
To asses the safety: Adverse events, vital signs, electrocardiograms (ECGs), laboratory variables.
时间窗: From screening period to follow-up visit, 40 days (Maximum).
次要结局
- To characterize the pharmacokinetics of AZD2423 in plasma and urine.(Blood and urine sampling from pre-dose until follow-up visit, 10 days (approximately))
- Exploratory endpoints;Levels of CCL2 pre-and post dose(Blood sampling after dosing, 3 days)
研究者
研究点 (1)
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