A Phase I, Single-centre, Single-blind, Randomised, Placebo-controlled, Single-dose Study to Assess the Safety, Tolerability and Pharmacokinetics After Single Ascending Intravenous Doses of AZD2927 in Healthy Male Subjects
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 AZD2927, day 3
研究概览
简要总结
In this early phase study, healthy male volunteers will be randomly assigned to one dose of either AZD2927 or placebo. The objective will be to assess the Safety,Tolerability and Pharmacokinetics of AZD2927.
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
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 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
- •Healthy male subjects aged 18 to 45 years inclusive with suitable veins for cannulation or repeated venepuncture
- •Male subjects should be willing to use barrier contraception ie, condoms, from the day of dosing until 3 months after dosing with the Investigational Product (IP)
- •Have a body mass index (BMI) between 19.0 and 30.0 kg/m2 and weight of at least 50.0 kg and no more than 100.0 kg
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, mental, cardiac, hepatic or renal disorder, or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
- •Abnormal vital signs, after 10 minutes supine rest
- •Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the administration of IP
- •Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator
研究组 & 干预措施
1
干预措施: AZD2927 (Drug)
2
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability of AZD2927, day 3
时间窗: Monitoring of Adverse events, Electrocardiograms, vital signs, and safety lab on day 3.
Safety and tolerability of AZD2927, at screening
时间窗: Monitoring of Adverse events, Electrocardiograms, vital signs, safety lab and ophtalmologic variables at screening
Safety and tolerability of AZD2927, day 1
时间窗: Monitoring of Adverse events, Electrocardiograms, vital signs, safety lab and ophtalmologic variables on day 1.
Safety and tolerability of AZD2927, day 2
时间窗: Monitoring of Adverse events, Electrocardiograms, vital signs and safety lab on day 2.
Safety and tolerability of AZD2927, at follow up
时间窗: Monitoring of Adverse events, Electrocardiograms, vital signs and safety lab at follow up.
次要结局
- Pharmakokinetic for AZD2927 measured by Cmax, tmax, AUC, t1/2, CL and Vss, day 1(Pharmacokinetic sampling will be performed day 1)
- Pharmakokinetic for AZD2927 measured by Cmax, tmax, AUC, t1/2, CL and Vss, day 2(Pharmacokinetic sampling will be performed day 2)
- Pharmakokinetic for AZD2927 measured by Cmax, tmax, AUC, t1/2, CL and Vss, day 3(Pharmacokinetic sampling will be performed day 3)