NCT01030224已完成1 期
A Phase-1, Single Center, Double Blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Intravenous AZD9742 After Single Ascending Doses in Healthy Male and 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
- 48
- 试验地点
- 1
- 主要终点
- Safety and tolerability of AZD9742 will be assessed by incidence and severity of AE's, abnormalities in vital signs, ECG's, telemetry, clinical laboratory assessments, physical exams and withdrawals
研究概览
简要总结
The main purpose of this study is to assess the safety, tolerability and PK of AZD9742 after single IV doses.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 23 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of signed and dated, written informed consent prior to any study specific procedures.
- •Clinically normal physical findings and laboratory values as judged by the investigator with normal ECG.
- •Healthy male and female volunteers. Females must be of non childbearing potential.
排除标准
- •Clinically significant illness or clinically relevant trauma, as judged by the investigator, within 4 weeks of the first administration of the Investigational Product
- •History of any disease or condition known to interfere with the absorption, distribution, metabolism or excretion of drugs
研究组 & 干预措施
Placebo to AZD9742 IV Infusion
Placebo Comparator
Placebo
干预措施: Placebo to match AZD9742 (Drug)
AZD9742 IV Infusion
Experimental
Active
干预措施: AZD9742 (Drug)
结局指标
主要结局
Safety and tolerability of AZD9742 will be assessed by incidence and severity of AE's, abnormalities in vital signs, ECG's, telemetry, clinical laboratory assessments, physical exams and withdrawals
时间窗: Assessments taken at Visit 1 (enrollment), defined timepoints pre-dose and post-dose during Visit 2 (residential period) and at Visit 3 (follow up). Volunteers will be monitored througout the study from Visit 1 through Visit 3 for adverse events.
次要结局
- Pharmacokinetic profile: to characterize the pharmacokinetics of AZD9742 in blood and urine(Samples taken during Visit 2 (residential period) at defined timepoints pre-dose and post-dose.)
研究者
研究点 (1)
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