NCT01555749已完成1 期
A Randomised, Double-blind, Placebo-controlled, Single Centre, Single Dose Trial, Assessing the Pharmacokinetics of NNC172-2021, Administered Subcutaneously at Two Different Dose Levels, 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
- 8
- 试验地点
- 1
- 主要终点
- Area under the curve from time point 0 to infinity (AUC0-∞) of NNC172-2021
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to investigate the pharmacokinetics (how the trial drug is distributed in the body) of NNC172-2021 administered subcutaneously, at two different dose levels, in healthy Japanese subjects.
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
- 20 Years 至 64 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male Japanese subjects defined as: Subjects born in Japan, time residing outside of Japan does not exceed 5 years, both parents and all 4 grandparents of Japanese descent
- •Body weight between 50 and 100 kg, both inclusive
- •Body mass index (BMI) between 18.0 and 30.0 kg/m^2, both inclusive
排除标准
- •Male subjects who are sexually active and not surgically sterilised who, or whose partner, are unwilling to use two different forms of effective contraception, one of which has to be a barrier method of contraception (e.g. condom with spermicidal foam/gel/film/cream) for the duration of the trial and for 3 months following the last dose of trial medication
- •Planned surgery 30 days prior to trial product administration and/or during the entire trial period
- •Known hepatic dysfunction during the last 12 months prior to screening (Visit 1)
- •Positive urine test for drugs of abuse
- •Active hepatitis B and/or hepatitis C infection
- •Positive for human immunodeficiency virus (HIV)
- •Subjects with clinical signs of thromboembolic events, considered to be at high risk of thromboembolic event or subjects with a known first degree family history of thromboembolism
- •Participation in any other trial investigating other products or involving blood sampling within the last 30 days prior to screening
- •Use of non-steroidal anti-inflammatory drugs (NSAIDs) such as acetylsalicylic acid (ASA), but not ibuprofen and cyclooxygenase-2 (COX-2) specific inhibitors within 2 weeks prior to trial product administration (Visit 2)
- •Positive alcohol test at screening (Visit 1) and/or history of alcohol or drug abuse within the last 12 months prior to screening (Visit 1)
- •Smokers; defined as tobacco users smoking more than 5 cigarettes per day or the corresponding amount of tobacco consumption
- •Blood donation within the last 3 months prior to screening and/or during the entire trial period
- •Strenuous exercise (as judged by the trial physician) within the last 4 days prior to screening (Visit 1)
研究组 & 干预措施
NNC172-2021 low dose / Placebo
Experimental
干预措施: NNC172-2021 (Drug)
NNC172-2021 low dose / Placebo
Experimental
干预措施: placebo (Drug)
NNC172-2021 high dose / Placebo
Experimental
干预措施: NNC172-2021 (Drug)
NNC172-2021 high dose / Placebo
Experimental
干预措施: placebo (Drug)
结局指标
主要结局
Area under the curve from time point 0 to infinity (AUC0-∞) of NNC172-2021
时间窗: Week 5
次要结局
- Number of adverse events (AEs)(Week 5)
- Presence of antibodies against NNC172-2021(Week 5)
- TFPI concentration measured by tissue factor pathway inhibitor (TFPI) enzyme-linked immunosorbent assay (ELISA)(Week 5)
- Residual tissue factor pathway inhibitor (TFPI) functionality measured by coagulation factor Xa (FXa) generation(Week 5)
- Maximal concentration of NNC172-2021 (Cmax)(Week 5)
- Time point for maximal concentration (tmax)(Week 5)
- Terminal half-life (t1/2)(Week 5)
研究者
研究点 (1)
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