Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Effect of SAR445611 on inflammatory responses following LPS challenge study in healthy participants

This study is investigating a new medicine, known as SAR445611, and how it affects the immune system. Specifically, researchers want to understand if this medicine can help control the body's inflammatory response, which is how your body reacts to things like infections or injuries. They will give participants a substance (LPS challenge) that briefly triggers this response to see if SAR445611 changes it. This early-stage study is looking for healthy men, aged 18 and older, to take part. It helps doctors learn more about how new medicines work in people and if they might be helpful for conditions affecting the immune system in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Sanofi-Aventis Recherche & Developpement

Enrolment target

Start

12 Jun 2024

Immune system diseases

What is this study about?

This study is about a new medicine called SAR445611. The main goal is to find out how this medicine affects the body's immune system, specifically its 'inflammatory response'. Inflammation is a natural way your body deals with things like infections or injuries, but sometimes it can be too strong or last too long, leading to health problems.

To understand how SAR445611 works, participants will be given a small amount of a substance called LPS (lipopolysaccharide). This substance is known to safely trigger a temporary inflammatory response, similar to how your body reacts to some kinds of bacteria. The researchers will then check if SAR445611 can change or control this response. This helps them learn if the medicine could be useful for conditions where the immune system is overactive.

This is a very early-stage study, meaning it's one of the first times this medicine is being tested in people. Because of this, it needs healthy volunteers. The information gathered will help scientists understand the medicine better and decide if it's safe and promising enough to be tested in people who actually have immune system conditions in the future.

Key takeaways

This study is testing a new medicine called SAR445611.
It aims to understand how the medicine affects the body's immune response.
Healthy men, aged 18 or older, are needed to take part.
It's an early-stage study, helping scientists learn about the medicine.
No direct health benefits are expected for participants.

Who may be eligible?

This study is looking for healthy volunteers. To take part, you must be a man and be at least 18 years old. There is no upper age limit, meaning men of any age 18 and above can be considered.

The study needs healthy participants in this early stage to make sure any effects seen are due to the medicine and not other health conditions. If you have ongoing health problems, especially those affecting your immune system, this study might not be suitable for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a man?
Are you 18 years old or older?
Are you generally healthy?
Are you able to commit to several study visits?

Answer every question to see your result.

What does participation involve?

The detailed information about what taking part involves was not provided in the summary. However, in studies like this one, you would typically have an initial screening visit to check if you are suitable. If you qualify, you would then likely attend several study visits at a clinic. During these visits, you might receive the study medicine (SAR445611) and the LPS substance. Researchers would take blood samples, check your vital signs (like blood pressure and heart rate), and ask about how you are feeling. You might also need follow-up visits after the medicine is given. The total duration of your participation could range from a few days to several weeks, depending on the study design.

Potential risks and benefits

Participating in research always carries potential benefits and risks. A potential benefit could be helping scientists learn more about new medicines and treatments for immune system conditions, which could help many people in the future. However, there is no direct personal health benefit expected for participants in this study, as it's an early-stage study in healthy volunteers. Potential risks could include side effects from the study medicine or from the LPS substance, such as feeling unwell, fever, or pain where blood samples are taken. All participants have the right to withdraw from the study at any time, for any reason, without it affecting their medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands

Common questions

What is SAR445611?

SAR445611 is a new medicine being tested to see how it affects the body's immune system and inflammatory responses.

What does 'LPS challenge' mean?

An 'LPS challenge' means you'll be given a small amount of a substance that safely causes a temporary inflammatory reaction, similar to what happens during an infection. This helps researchers see how the medicine works.

Will this medicine treat a disease I have?

No, this study is for healthy volunteers and is testing a new medicine. There's no expectation it will treat any existing conditions you might have.

What are 'immune system diseases'?

These are conditions where the body's defence system (immune system) doesn't work correctly, sometimes attacking the body itself or overreacting to harmless things.

Will I get paid for taking part?

The information provided doesn't say if payment is offered. This is a good question to ask the study team.