NCT02249117已完成1 期
Pharmacokinetics and Pharmacodynamics of BIWH 3: a Randomised, Placebo-controlled, Double Blind Dose Escalation Study (0.02, 0.06, 0.2, 0.6, and 2.0 μg/kg Intravenous Over One Hour) in Healthy Duffy Positive vs. Duffy Negative Male Volunteers
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
- 36
- 主要终点
- Area under the plasma concentration-time curve extrapolated to infinity (AUC0-∞)
研究概览
简要总结
Study to compare the pharmacokinetic and pharmacodynamic effects of escalating dosages of recombinant human pyro-Glu MCP-1 (BIWH 3) in Duffy positive vs. Duffy negative healthy male volunteers: plasma levels of monocyte chemotactic protein-1 (MCP-1) and markers of leukocyte, coagulation, platelet and endothelial activation will be quantified; To examine the safety of BIWH 3 in this setting
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
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects as determined by results of screening
- •Erythrocyte Fy positive and negative individuals because expression of the Duffy (Fy) receptor may influence MCP-1 plasma levels in humans
- •Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
- •Age ≥ 18 and ≤ 50 years
- •Body mass index: ≥18 kg/m2 and < 30 kg/m2
- •Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
- •Normal laboratory variables unless the investigator considers an abnormality to be clinically irrelevant
- •Normal pharmacodynamic variables as determined at baseline visit
- •Normal response to glucose tolerance test
排除标准
- •Any finding in the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- •Current or history of: gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, autoimmune, hormonal disorders, diseases of the central nervous system (such as epilepsy), psychiatric disorders or cancer
- •Symptoms of a clinically relevant illness in the 3 weeks prior to planned administration of study drug
- •History of orthostatic hypotension, fainting spells and blackouts
- •Chronic or relevant acute infections
- •History of allergy / hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- •Any Electrocardiogram (ECG) value outside the reference range of clinical relevance including, but not limited to QRS interval > 110 ms or QTcB > 450 ms
- •Intake of drugs with a long half-life (> 24 hours) within 1 month prior to planned administration of study drug
- •Use of any drugs which might influence the results of the trial within 10 days prior to planned administration or during the trial
- •Participation in another trial with an investigational drug within 2 months prior to planned administration or during trial
- •Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
- •Current or history of drug, alcohol, tobacco or caffeine abuse
- •Blood donation within 1 month prior to planned administration or during the trial
- •Excessive physical activities within 5 days prior to planned administration of study drug or during the trial
- •Seropositivity for hepatitis B antigen (HBs-Ag), hepatitis C (HCV), HIV 1, or HIV 2 antibodies
- •Weight over 95 kg
研究组 & 干预措施
BIWH 3
Experimental
single escalating dose
干预措施: BIWH 3 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Area under the plasma concentration-time curve extrapolated to infinity (AUC0-∞)
时间窗: up to 14 days after drug administration
maximum BIWH 3 plasma concentration (Cmax)
时间窗: up to 14 days after drug administration
Area under the plasma concentration-time curve up to the last quantifiable plasma concentration (AUC0-tz)
时间窗: up to 14 days after drug administration
次要结局
- Activation of coagulation(up to 14 days after drug administration)
- Number of subjects with clinically significant findings in vital signs(up to 14 days after drug administration)
- Number of subjects with clinically significant findings in ECG(up to 14 days after drug administration)
- Number of subjects with clinically significant findings in laboratory tests(up to 14 days after drug administration)
- Number of subjects with adverse events(up to 14 days after drug administration)
- Monocyte activation(up to 14 days after drug administration)
- Platelet cell activation(up to 14 days after drug administration)
- Endothelial cell activation(up to 14 days after drug administration)
- Inflammatory response(up to 14 days after drug administration)
研究者
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