NCT01522794已完成1 期
Randomized Double Blind Placebo Controlled PK/PD Study on the Effects of a Single Intravenous Dose of NOX-H94 on Serum Iron During Experimental Human Endotoxemia
TME Pharma AG1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2012年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- serum iron
研究概览
简要总结
The purpose of this study is to assess the effect of the anti-hepcidin Spiegelmer NOX-H94 on iron homeostasis during systemic inflammation induced by endotoxin.
In the human endotoxemia model, intravenously administered lipopolysaccharide elicits an inflammatory response with release of pro-inflammatory cytokines, such as IL-6 and TNF-alfa, with subsequent induction of hepcidin. As a consequence of hepcidin induction, serum iron concentrations decrease.
This study in healthy subjects investigates the capacity of NOX-H94 to inactivate hepcidin and to prevent serum iron decrease in a pathophysiological model prior to studying the efficacy of NOX-H94 in patients with anemia of chronic disease.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •BMI between 18 and 30 kg/m², with a lower limit of body weight of 50 kg
- •Healthy as determined by medical history, physical examination, vital signs, 12 lead electrocardiogram, and clinical laboratory parameters
- •Serum iron and red blood parameters Hb, MCV, ferritin, serum iron, and total iron binding capacity within reference range
排除标准
- •Use of any medication, recreational drugs or anti-oxidant vitamin supplements within 7 days
- •Use of caffeine, nicotine, or alcohol within 1 day
- •Previous participation in a trial where LPS was administered
- •Surgery or trauma with significant blood loss or blood donation within 3 months
- •History, signs or symptoms of cardiovascular disease (vaso-vagal collapse or of orthostatic hypotension, Resting pulse rate ≤45 or ≥100/min, Hypertension, Hypotension, ECG conduction abnormalities)
- •Renal impairment: plasma creatinine >120 µmol/L
- •Liver function tests (alkaline phosphatase, AST, ALT and γ-GT) outside of the reference range or total bilirubin >20 µmol/L
- •Hemoglobin or iron parameters (iron, transferring saturation, ferritin) outside of the reference ranges
- •History of asthma
- •Immuno-deficiency
- •Positive test of HIV type 1/2 antibodies, HBs antigen, HBc antibodies and HCV antibodies unless antibody titer is induced by vaccination
- •CRP > reference range or clinically significant acute illness, including infections, within 2 weeks
- •Treatment with investigational drugs or participation in any other clinical trial within 30 days prior to study drug administration
- •Known or suspected of not being able to comply with the trial protocol
- •Inability to personally provide written informed consent and/or take part in the study
研究组 & 干预措施
NOX-H94
Experimental
Single dose of NOX-H94
干预措施: NOX-H94 (Drug)
Placebo
Placebo Comparator
Single dose of placebo control
干预措施: Placebo solution (Drug)
结局指标
主要结局
serum iron
时间窗: 9 hours
Change versus baseline; comparison of subjects treated with NOX-H94 versus placebo
次要结局
- Pharmacokinetics: AUC of NOX-H94(0-2 weeks)
- Pharmacokinetic profile of NOX-H94(12 time points over 2 Weeks)
- Safety and tolerability(up to 2 Weeks)
- Pharmacokinetics: Clearance of NOX-H94(0-2 weeks)
- Pharmacodynamics: Effects of NOX-H94 on Iron homeostasis(up to 2 Weeks)
- Effects of NOX-H94 on innate immune response(up to 2 weeks)
- Pharmacokinetics: Cmax of NOX-H94(Day 1)
- Pharmacodynamics: effect of NOX-H94 on Red blood cell parameters(0- 2 weeks)
研究者
研究点 (1)
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