临床试验/NCT00951873

NCT00951873已完成1 期

A Single-centre, Randomised, Placebo-controlled, Double-blind Single Dose, Dose Escalation Trial Investigating Safety, Pharmacokinetics and Local Tolerability of Ascending Subcutaneous Doses of Long Acting-rFVIIa in Healthy Male Subjects

Novo Nordisk A/S0 个研究点目标入组 38 人开始时间: 2009年7月最近更新: 2016年5月13日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Novo Nordisk A/S
入组人数: 38
主要终点: Number of adverse events

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, local tolerability and pharmacokinetic profile (the determination of the concentration of the administered medication in blood over time) of long acting activated recombinant human factor VII when injected subcutaneously (under the skin).

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: 18 Years 至 45 Years（Adult）
性别: Male
接受健康志愿者: 是

入选标准

•Caucasian origin
•Body weight between 50 and 100 kg and a Body Mass Index (BMI) between 18.0 and 28.0 kg/m2 inclusive
•Smoke less than 10 cigarettes/day or equivalent and willingness to abstain from smoking during the entire duration of Trial Product Administration (9 days)

排除标准

•Known or suspected allergy to trial product or related products, such as activated recombinant human factor VII (NovoSeven®)
•Previous participation in this trial, defined as randomised to receive trial product
•Evidence of clinically relevant pathology or potential thromboembolic risk as judged by the Investigator
•Known history of atherosclerosis or thromboembolic events
•Overt bleeding, including from gastrointestinal tract
•Hepatitis B or C infection
•HIV infection
•Positive test for drugs of abuse

研究组 & 干预措施

A

Experimental

干预措施: activated recombinant human factor VII, long acting (Drug)

B

Placebo Comparator

干预措施: placebo (Drug)

C

Experimental

干预措施: activated recombinant human factor VII, long acting (Drug)

结局指标

主要结局

Number of adverse events

时间窗: assessed throughout the trial period from visit 1 to visit 5

次要结局

Area under activity concentration-time curve from time zero to infinity(assessed up to 168 hours after trial product administration)

研究者

发起方

Novo Nordisk A/S

申办方类型

Industry

责任方

Sponsor

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