Actively Recruiting
Immunomodulatory Effects of Dexamethasone, Tocilizumab and Anakinra During Experimental Human Endotoxemia
Led by Radboud University Medical Center · Updated on 2025-04-04
52
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of the drugs dexamethasone, tocilizumab, and anakinra on immune system changes and brain inflammation in healthy men aged 18 to 35. The study uses a repeated human endotoxemia model where participants receive a bacterial endotoxin called LPS to mimic sepsis-like inflammation. The goal is to understand how these drugs influence immune suppression and neuroinflammation compared to a placebo. Participants are divided into groups receiving one of the three drugs or a placebo before two LPS challenges one week apart. A control group will not receive LPS or drug treatment but will undergo the same sample collections. Blood, saliva, tear fluid, and cerebrospinal fluid will be collected during the challenges. Drug infusions and placebo treatments are given intravenously over one hour during the first LPS challenge. Participants will visit the research department up to five times, including screening. During visits, samples are taken regularly to study immune responses, including TNF and other cytokines in blood and cerebrospinal fluid. Researchers will use RNA sequencing to analyze immune cell activity and measure drug levels. The study includes safety monitoring and aims to provide detailed insights into inflammation and immune regulation over about eight days of observation.
CONDITIONS
Brief Title
Immunomodulatory Effects of Dexamethasone, Tocilizumab and Anakinra During Experimental Human Endotoxemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male subjects aged 18 to 35 years
- Body mass index (BMI) between 18 and 30 kg/m2
- Healthy as determined by medical history, physical exam, vital signs, ECG, and routine lab tests
- Able to understand and sign informed consent prior to enrollment
You will not qualify if you...
- Use of any prescription medication or over-the-counter non-steroidal anti-inflammatory drugs
- Known anaphylaxis or hypersensitivity to study drugs or their components
- History of chronic headache or post-dural puncture headache
- History or signs of severe atopic syndrome such as asthma, rhinitis with medication, or eczema
- History of any immune deficiency condition
- History of cancer in the last 5 years except localized skin cancer or carcinoma in situ
- History or signs of hematological disease
- History or signs of thromboembolic disorders
- History of peptic or gastric ulcer disease
- History of psychiatric disorders
- Low platelet count or anemia
- History or symptoms of cardiovascular disease including vagal collapse, arrhythmias, conduction abnormalities, hypertension, or hypotension
- Renal impairment defined by high plasma creatinine
- Liver enzyme abnormalities above twice the normal limit
- Signs of infection or recent clinically significant illness within 1 month before LPS challenge
- Prior participation in endotoxin administration studies
- Participation in experimental intervention or drug trials within 3 months before LPS challenge
- Vaccination or blood donation within 1 month before LPS challenge
- Recent hospital admission or surgery with general anesthesia within 3 months before LPS challenge
- Use of recreational drugs within 2 weeks before LPS challenge
- Inability to comply with the trial protocol or provide informed consent due to language or mental reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 week
Participants receive one of the study drugs or placebo infusion during the first experimental human endotoxemia challenge, followed by a second endotoxemia challenge one week later to assess immunomodulatory effects.
2 visits (in-person) on day 0 and day 7 for endotoxemia challenges
Duration - Up to 8 days after second endotoxemia challenge
Participants are monitored for inflammatory and immunological responses in blood, cerebrospinal fluid, saliva, and tear fluid up to 8 days, including cellular and molecular assessments.
Multiple assessments during and after treatment period
Trial Site Locations
Total: 1 location
1
Intensive Care Medicine, Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, Netherlands, 6500 HB
Actively Recruiting
Research Team
N
Nicole Waalders, MD
M
Matthijs Kox, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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