NCT01028040已完成1 期
Phase I, Single Centre, Open Label Study to Access The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous AZD3043 After A) a Single Ascending Bolus Dose and B) a Single Ascending Bolus Dose Followed by a Single Infusion Dose in Healthy Japanese Volunteers (Age Range 20-45 Years)
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
- 72
- 试验地点
- 1
- 主要终点
- To assess the safety and tolerability of AZD3043 following administration of SAD bolus (Part A) and SAD bolus followed by infusion (Part B).
研究概览
简要总结
This is a single centre, open label, non-randomised study to access the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD3043 following a single dose administration to Japanese subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Japanese male and females of non-childbearing potential aged ≥20 to ≤ 45 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, 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.
- •History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
- •Any clinically significant illness/infection or medical/surgical procedure or trauma, as judged by the Principal Investigator, within 4 weeks of the first administration of investigational product.
- •Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis as judged by the Investigator
研究组 & 干预措施
AZD3043
Experimental
干预措施: AZD3043 (Drug)
结局指标
主要结局
To assess the safety and tolerability of AZD3043 following administration of SAD bolus (Part A) and SAD bolus followed by infusion (Part B).
时间窗: From screening period to follow-up visit 42 days (Maximum)
次要结局
- To evaluate the onset, level and recovery of/from sedation/anaesthesia.(Assessed on Day 1)
- To characterize the PK of AZD3043 and its main metabolite (THRX-108893) & provisionally assess the dose-proportionality of the PK(Blood and urine sampling from pre-dose until follow-up visit, 10 days (approximately))
研究者
研究点 (1)
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