Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study to investigate how different tablet types of balinatunfib and food will influence the absorption of balinatunfib in blood in healthy adult participants

This research study is investigating a new medicine called balinatunfib, which is being developed to help people with immune system problems. The main goal is to understand how the body absorbs this medicine into the bloodstream under different conditions. Researchers want to see if taking balinatunfib in different types of tablets, or taking it with or without food, changes how much of the medicine gets into the blood. This information is really important because it helps scientists work out the best way to give the medicine for it to be most effective. Healthy adult volunteers will take part in this early-stage study.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Sanofi-Aventis Recherche & Developpement

Enrolment target

Start

26 May 2025

Immune system diseases

What is this study about?

This study is about a new medicine called balinatunfib. It's being developed to help people who have diseases affecting their immune system, which is the body's natural defense against illness. Before a medicine can be given to patients, researchers need to understand a lot about how it works in the body. One very important thing to know is how well the body takes in the medicine – this is called absorption.

In this study, the researchers want to see exactly how balinatunfib gets into your blood. They are particularly interested in two things: first, if different types of tablets (like different coatings or ways the medicine is put together) change how it's absorbed; and second, if taking the medicine with food, or on an empty stomach, makes a difference. This is a very early stage study, often called Phase 1, which means it's one of the first times the medicine is being tested in people.

The information gathered from this study is crucial. It helps the scientists choose the best tablet form and the best way to take the medicine (for example, with or without food) so that it can work as effectively as possible for future patients. By understanding absorption better, they can make sure the right amount of medicine reaches the body to have the desired effect on immune system diseases.

Key takeaways

This study is testing a new medicine for immune system diseases called balinatunfib.
It aims to find the best way for the body to absorb the medicine from different tablet types.
Researchers are also checking if taking the medicine with or without food makes a difference.
It's an early-stage study involving healthy adult volunteers.
The results will help make the medicine more effective for future patients.

Who may be eligible?

This study is looking for healthy adult volunteers to take part. This means you should be generally well and not have any serious or ongoing health conditions, especially those affecting your immune system.

To be eligible, you must be at least 18 years old. There isn't an upper age limit mentioned, but you would still need to meet all the other health requirements.

Both men and women are welcome to participate in this research. The study will check your medical history and do some health assessments to make sure it's safe for you to take part.

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 at least 18 years old?
Are you generally healthy with no serious existing medical conditions?
Are you able to attend regular clinic visits?
Are you comfortable with blood tests and other health checks?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be given doses of the study medicine, balinatunfib, in different tablet forms and possibly in different ways (with or without food). You'll have regular visits to the clinic where doctors and nurses will check your health. This will involve things like blood tests to measure how much of the medicine is in your system, and checks of your blood pressure and other vital signs. You will be closely monitored throughout the study period. The total duration of your participation will be explained in detail before you start, including how many visits you'll need to make and for how long.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is contributing to important medical knowledge that could help future patients with immune system diseases. There might not be direct health benefits to you personally, as this is an early study primarily focused on understanding how the medicine works. Potential risks might include side effects from the study medicine, or discomfort from procedures like blood tests. All known potential side effects will be fully explained to you. You have the right to withdraw from the study at any time, for any reason, without it affecting your 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
Belgium

Common questions

What is an immune system disease?

An immune system disease is a condition where your body's natural defense system, which fights off infections, doesn't work correctly. It might attack your own body or not fight off germs properly.

Why do they need healthy people for this study?

For early-stage studies like this, healthy people are often included first to see how the new medicine works in a body that isn't already dealing with an illness. This helps researchers understand the basic effects of the medicine more clearly.

Will I know if I'm taking the medicine with food or not?

Yes, the study team will give you very specific instructions about when and how to take the medicine, including whether it should be with a meal or on an empty stomach, according to their plan.

What does 'absorption in blood' mean?

This means how much of the medicine actually gets from your stomach or gut into your bloodstream after you swallow it. This is important because the medicine needs to be in your blood to travel to where it's needed in your body.

Will I get paid for taking part?

Payment for participation varies between studies. This is a very important question to ask the research team directly when you discuss the study, as they will provide all details about compensation or travel expenses.