NCT01228669已完成1 期
A Multi-centre, Randomised, Double-blind, Placebo-controlled, Single Dose, Dose Escalation Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC 0172-0000-2021 Administered Intravenously and Subcutaneously to Healthy Male Subjects and Haemophilia 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
- 52
- 试验地点
- 1
- 主要终点
- Number of adverse Events (AEs), including Serious Adverse Events (SAEs)
研究概览
简要总结
This trial is conducted in Europe and Asia. The aim of this clinical trial is to investigate the safety, pharmacokinetics (how the trial drug is distributed in the body) and pharmacodynamics (physiological effects of the drug on the body) of NNC 0172-0000-2021 administered intravenously and subcutaneously to healthy male subjects and subjects with haemophilia A or B
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Body weight between 50 and 100 kg, both inclusive
- •Body mass index (BMI) between 18.0 kg/m2 and 25.0 kg/m2, both inclusive
- •For haemophilia subjects only: Diagnosed with severe haemophilia A or B
排除标准
- •Known or suspected hypersensitivity to trial product(s) or related products
- •Surgery planned to occur during the trial
- •Any major and/or orthopaedic surgery within 30 days prior to trial product administration
研究组 & 干预措施
A
Experimental
干预措施: NNC 0172-0000-2021 (Drug)
B
Experimental
干预措施: NNC 0172-0000-2021 (Drug)
C
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Number of adverse Events (AEs), including Serious Adverse Events (SAEs)
时间窗: from trial product administration until 43 days after trial product administration
次要结局
- Area under the concentration-time curve(from 43 days after trial product administration until 53 days after trial product administration)
- Adverse Events (AEs), including Serious Adverse Events (SAEs)(from 43 days after trial product administration until 53 days after trial product administration)
研究者
研究点 (1)
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