Effect of different drugs on the immune response during inflammation: the DEDICATE-LPS study

Phase 1

• Conditions: Inflammatory response following human endotoxemia in healthy volunteers; Therapeutic area: Phenomena and Processes [G] - Immune system processes [G12]

• Registration Number: CTIS2023-506556-24-00
• Lead Sponsor: Stichting Radboud University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-25
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 52

Inclusion Criteria

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.

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified