Study on the Effects of Dexamethasone, Tocilizumab, and Anakinra on Inflammation in Healthy Volunteers

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What is this study about?

This clinical trial is focused on understanding how certain medications affect the body’s immune response during inflammation. The study involves healthy volunteers and examines the effects of three medications: dexamethasone, tocilizumab, and anakinra. These medications are being tested to see how they influence the body’s reaction to a condition called human endotoxemia, which is a model used to study inflammation in a controlled setting.

The purpose of the study is to explore how these medications can modify the immune system’s response during inflammation. Participants will receive one of the medications or a placebo, and their immune responses will be monitored. The study will involve repeated exposure to a substance called lipopolysaccharide (LPS), which is used to trigger an inflammatory response in the body. This will help researchers understand how the medications affect the immune system over time.

Throughout the study, participants will undergo various tests and assessments to measure changes in their immune response. These tests will include monitoring levels of certain proteins and substances in the blood that are associated with inflammation. The study aims to provide valuable insights into how these medications can potentially be used to manage inflammatory conditions in the future.

1 initial visit and consent

Upon joining the study, you will attend an initial visit where the study team will explain the trial in detail. You will be asked to read and sign an informed consent form, which confirms your understanding and agreement to participate.

2 baseline assessments

Before starting the trial, baseline assessments will be conducted. These include a review of your medical history, a physical examination, and routine laboratory tests to ensure you meet the study criteria.

3 first medication administration

You will receive the first dose of the study medication. This may include dexamethasone, tocilizumab, or anakinra. The medication will be administered through an intravenous injection or infusion, depending on the specific drug.

4 first endotoxemia challenge

Following the medication administration, you will undergo the first endotoxemia challenge. This involves receiving a small dose of lipopolysaccharide from E. coli through an intravenous injection to trigger an immune response.

5 monitoring and assessments

After the endotoxemia challenge, you will be closely monitored. Blood samples will be taken to measure various immune markers and assess the effects of the medication. Vital signs such as blood pressure, heart rate, and temperature will also be recorded.

6 second medication administration

You will receive a second dose of the study medication, similar to the first administration. This is to evaluate the effects of repeated dosing on the immune response.

7 second endotoxemia challenge

A second endotoxemia challenge will be conducted, similar to the first. This helps in understanding the body’s response to repeated exposure and the medication’s impact.

8 final assessments and follow-up

After the second challenge, final assessments will be performed. These include additional blood tests and monitoring of your health status. You will be asked to attend follow-up visits to ensure your well-being and to gather long-term data on the effects of the medications.

Who Can Join the Study?

Male participants who are 18 to 35 years old.
Body mass index (BMI) between 18 and 30 kg/m². BMI is a measure of body fat based on height and weight.
Must be healthy, as determined by medical history, physical examination, vital signs, a heart test called a 12-lead electrocardiogram, and routine lab tests.
Able to understand and sign the Information letter and Informed Consent before joining the study. This means you understand the study and agree to participate.

Who Cannot Join the Study?

Participants must be healthy males. This means no females or individuals with health issues can join.
Participants should not be part of any vulnerable population. This refers to groups who might need special protection, like children or people with certain disabilities.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Sdpimtcqo Rakntrh Uqylbwvlie Mkgpcst Cijmpi	Nijmegen	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not recruiting	01.09.2024

Trial locations

Investigated drugs:

Dexamethasone is a medication that helps reduce inflammation in the body. It is often used to treat conditions where the immune system is overactive, such as allergies or autoimmune diseases. In this trial, it is being used to see how it affects the body’s immune response during a controlled situation where the immune system is intentionally activated.

Tocilizumab is a medication that blocks a specific protein in the body that can cause inflammation. It is commonly used to treat rheumatoid arthritis and other inflammatory conditions. In this study, researchers are examining how it influences the immune system’s activity when the body is exposed to a substance that triggers an immune response.

Anakinra is a medication that helps to reduce inflammation by blocking a protein in the body that contributes to inflammation. It is often used to treat conditions like rheumatoid arthritis. In this clinical trial, the focus is on understanding how anakinra affects the immune system when it is deliberately stimulated.

Investigated diseases:

Inflammation

Inflammatory Response Following Human Endotoxemia – This condition is characterized by the body’s immune response to endotoxins, which are components of the outer membrane of certain bacteria. When endotoxins enter the bloodstream, they trigger an inflammatory response. This response involves the release of various cytokines and other inflammatory mediators. The progression includes an initial acute phase where symptoms such as fever, chills, and increased heart rate may occur. As the body continues to respond, there may be changes in blood pressure and other systemic effects. The condition is typically studied in controlled settings to understand the immune system’s behavior and regulation.

Trial ID:

2023-506556-24-00

Protocol code:

114730

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects of Dexamethasone, Tocilizumab, and Anakinra on Inflammation in Healthy Volunteers

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?