NCT01958645已完成1 期
A Phase I, Single-blind, Randomised, Placebo-controlled, Single Centre Study to Investigate the Safety, Tolerability and Pharmacodynamics of Intravenous MEDI8111 After Single Ascending Doses in Healthy Male 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
- 157
- 试验地点
- 1
- 主要终点
- Description of the Safety Profile in Terms of Adverse Events (AE),Vital Signs, ECG, Lab Variables, Immunogenicity and Physical Examination
研究概览
简要总结
A study to investigate the safety, tolerability and pharmacodynamics of MEDI8111 after single ascending doses in healthy male.
详细描述
A phase I, single-blind, randomised, placebo-controlled, single centre study to investigate the safety, tolerability and pharmacodynamics of intravenous MEDI8111 after single ascending doses in healthy male 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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 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 18-40 years with suitable veins for cannulation or repeated venepuncture, Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weight at least 50 kg an no more than 100 kg inclusive, Male subjects should be willing to avoid fathering a child by either true abstinence or the use of two effective means of contraception from the day of dosing until 3 months after dosing with the IP. They should also be willing to use barrier methods from the day of dosing until 3 months after dosing.
排除标准
- •Prothrombotic mutation such as factor V Leiden, or deficiencies of protein C, protein S, prothrombin, antithrombin or APC, Antibodies to coagulation FII, History or family history of venous or arterial thromboembolic event, and/or myocardial infarction before age of 50 years, ETP level at baseline >2000nM/min, FII level (by clot) at screening and/or at baseline outside 50-250% of the normal range
研究组 & 干预措施
A
Experimental
MEDI8111
干预措施: MEDI8111 (Drug)
B
Placebo Comparator
Placebo for MEDI8111
干预措施: Placebo (Other)
结局指标
主要结局
Description of the Safety Profile in Terms of Adverse Events (AE),Vital Signs, ECG, Lab Variables, Immunogenicity and Physical Examination
时间窗: From screening and up to the lab follow-up visit (Day 29)
次要结局
- Change From Baseline Endogenous Thrombin Potential (ETP)(Predose and Days 1-5)
- Change From Baseline Factor II Concentrations by ECL Assay(Predose and 1-8 hours)
- Change From Baseline Factor II Concentrations by Clot Assay(Predose and 1-8 hours)
- Change From Baseline D-dimer Concentration(predose and 1-8 hours)
研究者
研究点 (1)
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