NCT02762799已完成1 期
Single-center Open Randomized Clinical Trial to Evaluate Pharmacokinetics, Pharmacodynamics and Safety of Leucostim® (JSC "BIOCAD", Russia) Compared to Neupogen® (F. Hoffman-La Roche Ltd., Switzerland)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Biocad
- 入组人数
- 60
- 主要终点
- AUC (0-48 Hours)
研究概览
简要总结
BCD-002-1 is 1 phase clinical trial to evaluate pharmacokinetics, pharmacodynamics and safety of single-injection of Leucostim® to healthy volunteers compared to Neupogen®
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
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
- •Written informed consent.
- •Male gender.
- •Age between 18 and 45 years.
- •Normal body mass index.
- •Verified diagnosis "healthy", established according to the anamnesis, physical examination and laboratory findings.
- •Absence of alcohol or drug abuse.
排除标准
- •History of use of filgrastim.
- •Allergy to any components of study drugs.
- •Acute hemorrhage, donation of blood / plasma or blood transfusions during last 2 months prior to enrollment in the study, history of chronic bleeding.
- •Surgical interventions during last 30 days prior to screening or planed surgical intervention during the study.
- •Any diseases that could interfere with pharmacokinetics of filgrastim, including chronic liver, liver or blood diseases, diseases of cardiovascular, lung and neuroendocrine systems.
- •Fever with body temperature higher than 40°С.
结局指标
主要结局
AUC (0-48 Hours)
时间窗: 0 to 48 hours post-dose
Area Under Curve (AUC) "concentration - time" from the moment of filgrastim injection to 48 hours
Cmax After Subcutaneous Injection
时间窗: 0 to 48 hours post-dose
Maximal concentration of filgrastim after subcutaneous injection of filgrastim
次要结局
- Frequency of Preliminary Withdrawal Due to AE/SAE(0 to 336 hours post-dose)
- Clearance(0 to 48 hours post-dose)
- Frequency of AE/SAE 3-4 Grade CTCAE 4.03(0 to 336 hours post-dose)
- Cmax After Intravenous Injection(0 to 48 hours post-dose)
- Т½(0 to 48 hours post-dose)
- Frequency of Local Reactions(0 to 336 hours post-dose)
- Tmax After Injection(0 to 48 hours post-dose)
- Kel(0 to 48 hours post-dose)
- Proportion of Patients With Binding or Neutralizing Antibodies to Filgrastim(0 to 336 hours post-dose)
- ANC-AUEC (0-336 Hours)(0 to 336 hours post-dose)
- ANC-Emax(0 to 336 hours post-dose)
- CD34-AUEC (0-336 Hours)(0 to 336 hours post-dose)
- CD34-Emax(0 to 336 hours post-dose)
- Overall Frequency of Serious Adverse Events (SAE)(0 to 336 hours post-dose)
- Overall Frequency of Adverse Events (AE)(0 to 336 hours post-dose)
研究者
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