NCT01021189已完成1 期
A Phase I, Randomised, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD1446 in Healthy Young and Elderly Japanese Volunteers After Oral Single and Multiple Ascending Doses
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
- 97
- 试验地点
- 1
- 主要终点
- To assess the safety and tolerability of AZD1446 following single and multiple ascending doses of an orally administered solution of AZD1446 in healthy young and elderly Japanese subjects by adverse events, vital signs, laboratory variables and ECG.
研究概览
简要总结
The primary aim of this study is to assess the safety and tolerability of AZD1446 following single and multiple ascending doses of an orally administered solution of AZD1446 in healthy young and elderly 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Japanese subjects, aged ≥20 to ≤50 years for male young subjects, ≥65 to ≤80 years for male or post-menopausal female elderly subjects.
- •BMI between 18 and 27 kg/m2 and weigh at least 50 kg and no more than 90 kg (for the elderly female, weigh at least 45 kg and no more than 90 kg).
排除标准
- •History of Quincke oedema or angiooedema, or history of repeated episodes of urticaria.
- •History or present symptoms or signs of asthma, airway hyperreactivity or obstructive lung disease.
研究组 & 干预措施
1
Experimental
AZD1446
干预措施: AZD1446 (Drug)
2
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
To assess the safety and tolerability of AZD1446 following single and multiple ascending doses of an orally administered solution of AZD1446 in healthy young and elderly Japanese subjects by adverse events, vital signs, laboratory variables and ECG.
时间窗: During the whole study period, ca. 50 days.
次要结局
- To determine pharmacokinetics(PK) of AZD1446 following single and multiple dosing of AZD1446 in healthy young and elderly Japanese subjects.(PK sampling taken at defined timepoints during residential period, 12 days.)
研究者
研究点 (1)
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