CTIS2023-506556-24-00进行中（未招募）1 期
Immunomodulatory effects of dexamethasone, tocilizumab and anakinra during experimental human endotoxemia: the DEDICATE-LPS study - 114532
Stichting Radboud University Medical Center0 个研究点目标入组 52 人开始时间: 2024年1月25日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 52
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（—）
- 性别
- Male
入选标准
- •Male subjects aged =18 and =35 years, Body mass index (BMI) =18 and =30 kg/m2, Healthy (as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram and routine clinical laboratory parameters), Able to comprehend and sign the Information letter and Informed Consent (IC) prior to enrolment in the study.
排除标准
- •Use of any prescription medication or over-the-counter non-steroidal anti-inflammatory drugs, History of psychiatric disorders, Thrombocytopenia (<150*109/mL) or anaemia (<8.0 mmol/L), History, signs or symptoms of cardiovascular disease (in particular: Prone to vagal collapse; History of atrial or ventricular arrhythmia; Cardiac conduction abnormalities on the ECG consisting of a 2nd degree atrio-ventricular block or a complete left bundle branch block; Hypertension (defined as RR systolic > 160 or RR diastolic > 90 mmHg); Hypotension (defined as RR systolic < 100 or RR diastolic < 50 mmHg)), Renal impairment (defined as plasma creatinine >120 µmol/L), Liver enzyme abnormalities (above 2x the upper limit of normal), Signs of infection (CRP > 20 mg/L, white blood cells > 12x109/L or < 4x109/L), Clinically significant acute illness, including infections or trauma, within 1 month prior to the first LPS challenge, Previous (participation in a study with) endotoxin (LPS) administration, Participation in an experimental intervention or drug trial within 3 months prior to the first LPS challenge, Any vaccination or blood donation within 1 month prior to the first LPS challenge, Known anaphylaxis or hypersensitivity to any (non-)investigational products or their excipients, Recent hospital admission or surgery with general anaesthesia within 3 months prior to the first LPS challenge, Use of recreational drugs within 2 weeks prior to the first LPS challenge, Suspected of not being able to comply with the trial protocol, Inability to personally provide written informed consent (e.g. for linguistic or mental reasons) and/or take part in the study, History of chronic headache or previous post-dural puncture headache (PDPH), History or signs of severe atopic syndrome (asthma, rhinitis with medication and/or eczema), History of any disease associated with immune deficiency, History of cancer in the last 5 years (excluding localised skin cancer or carcinoma in situ), History or signs of haematological disease, History or signs of thromboembolic disorders, History of peptic / gastric ulcer disease
研究者
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