DRKS00003478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
OXXON Pharma AG0 个研究点目标入组 24 人开始时间: 2012年1月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 35 Years（—）
- 性别
- Male
入选标准
- •Main Inclusion Criteria:
- •- 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
- •Main Exclusion Criteria:
- •- Use of any medication, recreational drugs or anti-oxidant vitamin supplements within 7 days
- •- Use of caffeine, nicotine, or alcohol or 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 ?-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
研究者
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