NCT01153997已完成1 期
A Randomised, Placebo-controlled Single-dose, Parallel-group, Double-blind Trial Evaluating Safety and Pharmacokinetics of Recombinant Factor XIII in Healthy Japanese 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
- 入组人数
- 24
- 主要终点
- Occurrence of serious adverse events
研究概览
简要总结
This trial is conducted in Japan. The aim of this trial is to investigate the safety profile of recombinant factor XIII (rFXIII) assessed by the occurrence of adverse events in healthy Japanese subjects. In addition pharmacokinetic parameters will be investigated.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Good general health based on assessment of medical history, physical examination, ECG (electrocardiogram) and clinical laboratory data at screening, as judged by the physician
- •Body mass index (BMI) between 18.0-27.0 kg/m2 (both inclusive)
排除标准
- •The receipt of any investigational products for coagulation factor protein within 6 months prior to trial start (screening)
- •Known or suspected allergy to yeast
- •Known bleeding or hematologic disorder
- •Significant history of alcoholism or drug/chemical abuse as judged by the physician or positive result in the alcohol breath test/screen of drugs at the trial start (screening)
- •Smoking more than 10 cigarettes/day or equivalent
- •Not able or willing to refrain from smoking whenever required for the trial procedures
- •Habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, soft drinks such as cola, chocolate) as judged by the physician
- •Excessive consumption of a diet deviating from a normal diet as judged by the physician
- •Strenuous exercise as judged by the physician within 4 days prior to trial start (screening)
- •Surgery or trauma with significant blood loss (500 mL or more blood) within 3 months prior to trial start (screening)
- •Males who are sexually active and not surgically sterilised, who or whose partner are not using adequate contraceptive methods. Adequate contraceptive measures include that the subject uses a condom during intercourse or that the partner practices adequate conception (sterilisation, hormonal intrauterine devices and oral contraceptives).
研究组 & 干预措施
A
Experimental
干预措施: catridecacog (Drug)
B
Experimental
干预措施: catridecacog (Drug)
C
Placebo Comparator
干预措施: placebo (Drug)
D
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Occurrence of serious adverse events
时间窗: from first trial related activity (visit 1) and up to 28 days (visit 8) after dosing
Occurrence of non-serious adverse events
时间窗: from first trial related activity (visit 1) and up to 28 days (visit 8) after dosing
次要结局
- AUC (area under the curve) from time zero to 28 days(at day 28)
研究者
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