NCT00687232已完成1 期
A Randomised, Placebo-controlled Single-blind, Single-centre Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Inhaled Doses of AZD4818 in Healthy Japanese Male 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
- 30
- 试验地点
- 1
- 主要终点
- Incidence and nature of adverse Event, 12-lead ECG, BP, pulse rate, body temperature, spirometry
研究概览
简要总结
The purpose is to investigate safety and tolerability of single and multiple ascending inhaled doses of AZD4818 in healthy Japanese male volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Provision of informed consent
- •Body Mass Index (BMI) between 18.0-27.0 kg/m2
- •No clinically relevant abnormal findings
排除标准
- •Acute illness which requires medical intervention
- •Definite or suspected personal history of adverse drug reactions or drug hypersensitivity.
- •Clinical relevant disease or disorder (past or present)
- •A history of respiratory disorders
研究组 & 干预措施
1
Experimental
AZD4818
干预措施: AZD4818 (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence and nature of adverse Event, 12-lead ECG, BP, pulse rate, body temperature, spirometry
时间窗: During the study
Lab assessment
时间窗: During the study
次要结局
- Pharmacokinetics(During the study)
研究者
研究点 (1)
Loading locations...
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