NL-OMON43493已完成不适用
A randomized double-blind placebo-controlled phase 1 study regarding safety, tolerability and pharmacokinetics/-dynamics of escalating single intravenous doses of ADRECIZUMAB (HAM 8101) in healthy male subjects. - ADRECIZUMAB-phase1
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 99（—）
入选标准
- •1. Written informed consent to participate in this trial prior to any study mandated
- •2. Male subjects aged 18 to 35 years, inclusive.
- •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
- •1. Unwillingness to abstain from any medication, recreational drugs, anti-oxidant 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 1 day prior to the treatment day and during the first 24 hours of the study.
- •3. Surgery or trauma with significant blood loss or blood donation within 3 months prior to the treatment day.
- •4. 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)
- •* Hypotension (RR systolic <100 or RR diastolic <50)
- •* 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
- •5. Renal impairment: plasma creatinine >120 µmol/L
- •6. Liver function tests (alkaline phosphatase, AST, ALT and/or *-GT) above 2x the upper limit of normal.
- •7. History of asthma
- •8. Atopic constitution
- •9. CRP above 2x the upper limit of normal or clinically significant acute illness, including infections, within 2 weeks before administration of the study drug.
- •10. Treatment with investigational drugs or participation in any other clinical trial within 30 days prior to study drug administration.
- •11. Known or suspected of not being able to comply with the trial protocol.
- •12. Known hypersensitivity to any excipients of the drug formulations used.
- •13. 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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