NL-OMON43006已完成不适用
A randomized double-blind placebo-controlled phase I study on the safety, tolerability and pharmacokinetics/-dynamics of escalating single intravenous doses of ADRECIZUMAB (HAM8101) in healthy male subjects during experimental endotoxemia. - Adrecizumab-LPS
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Adrenomed AG
- 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
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Written informed consent to participate in this trial prior to any study-mandated procedure.
- •2. Male subjects aged 18 to 35 years.
- •3. Subjects have to agree to use a reliable way of contraception with their partners from study entry until 3 months after study drug administration.
- •4. BMI between 18 and 30 kg/m², with a lower limit of body weight of 50 kg and a upper limit of 100 kg.
- •5. Healthy as determined by medical history, physical examination, vital signs, 12 lead electrocardiogram, and clinical laboratory parameters.
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation:
- •1. Unwillingness to abstain from any medication, including recreational drugs or vitamin supplements during the course of the study and within 7 days prior to the treatment day.
- •2. Unwillingness to abstain from smoking, or alcohol, within 1 day prior to the treatment day and 1 day after the treatment day.
- •3. Previous participation in a trial where LPS was administered.
- •4. Surgery or trauma with significant blood loss or blood donation within 3 months prior to the treatment day.
- •5. History, signs or symptoms of cardiovascular disease, in particular:
- •History of frequent vasovagal collapse or of orthostatic hypotension
- •Resting pulse rate <=45 or >=100 beats /min
- •Hypertension (RR systolic >160 or RR diastolic >90 mmHg)
- •Hypotension (RR systolic <100 or RR diastolic <50 mmHg)
- •Conduction abnormalities on the ECG consisting of a 1st degree atrioventricular block or a complex bundle branch block
- •Any chronic cardiac arrhythmias (except PAC*s, PVC*s)
- •6. Renal impairment: plasma creatinine > 120 µmol/L
- •7. Liver function tests (alkaline phosphatase, AST, ALT and/or γ-GT) above 2x the upper limit of normal.
- •8. History of asthma
- •9. Atopic constitution.
- •10. CRP above 2x the upper limit of normal, or clinically significant acute illness, including infections, within 2 weeks prior to the treatment day.
- •11. Treatment with investigational drugs or participation in any other clinical trial within 30 days prior to the treatment day.
- •12. Known or suspected of not being able to comply with the trial protocol.
- •13. Known hypersensitivity to any excipients of the drug formulations used.
- •14. Inability to personally provide written informed consent (e.g. for linguistic or mental reasons) and/or take part in the study.
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