Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Phase 1 study on SAR443122 bioavailability and food effect in healthy adults

This is an early-stage study, often called a Phase 1 trial, and it's looking at a new potential medicine named SAR443122. Specifically, researchers want to understand how this medicine behaves in the body of healthy adult volunteers. They will check how much of the medicine gets into the bloodstream and whether eating food changes this. The study is called a 'bioequivalence study' because it compares how the medicine is absorbed under different conditions. Understanding these things is a crucial first step in developing new treatments, and the medicine is being developed with the hope of one day helping people who have ulcerative colitis.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Sanofi-Aventis Recherche & Developpement

Enrolment target

Start

06 Jun 2025

Colitis ulcerative

What is this study about?

This study is a very early step in developing a new medicine, called SAR443122, for a gut condition called ulcerative colitis. Ulcerative colitis causes long-lasting swelling and sores in the large intestine.

In this first stage of research, the main goal is to understand how the medicine behaves inside the body. Researchers will give the new medicine to healthy adults and then carefully measure how much of it reaches the bloodstream and how quickly. They also want to see if eating food at the same time changes how the body takes in the medicine. This information is really important because it helps scientists work out the best way to give the medicine in the future.

Because this is an early-stage study, it's not designed to test if the medicine actually treats ulcerative colitis. Instead, it's about gathering basic information to make sure the medicine is safe enough to test in people with the condition later on. These early studies are essential to ensure new treatments are developed carefully and responsibly.

Key takeaways

This is an early-stage study in healthy adults for a potential new medicine for ulcerative colitis.
It aims to understand how the medicine SAR443122 is absorbed by the body.
Researchers will check if food affects how the medicine is taken up.
Participation involves clinic visits, blood tests, and taking the study medicine.
The study helps develop new treatments but doesn't prove the medicine treats colitis yet.
You can withdraw from the study at any time without penalty.

Who may be eligible?

This study is looking for healthy adults to take part. This means you should generally be well and not have any serious ongoing health problems or be taking a lot of regular medicines. You would need to be 18 years old or older to be considered.

Both men and women are welcome to participate in this research. The study will have specific health checks to make sure it's safe for you to take part and that the results will be clear and useful.

If you have ulcerative colitis, or any other significant long-term health condition, this study would likely not be suitable for you as it focuses on healthy volunteers at this early stage.

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 18 years old or older?
Are you generally healthy with no serious long-term medical conditions?
Are you able to attend several clinic appointments?
Are you comfortable with having regular blood tests?
Are you not currently pregnant or breastfeeding (if applicable)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would likely have several visits to a clinic. These visits would involve having blood samples taken quite regularly to measure the medicine levels in your body. You might also have general health checks like having your blood pressure taken or an ECG (heart tracing).

You would receive the study medicine, probably as a tablet or capsule, under different conditions – for example, once without food and once after a meal. You would need to follow specific instructions about eating and drinking before and during certain parts of the study. The total time you would be involved in the study, including all visits and follow-up, would be explained to you in detail.

Potential risks and benefits

Participating in research always carries some potential risks, like mild side effects from the medicine or discomfort from blood tests. However, this study is carefully designed, and you will be closely monitored by medical staff. The main benefit is helping scientists understand a new medicine, which could eventually lead to a treatment for ulcerative colitis. You will be fully informed of all known side effects before you decide to join, and you are completely free to leave 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
Netherlands

Common questions

What is ulcerative colitis?

Ulcerative colitis is a long-term condition that causes inflammation and sores in the lining of the large intestine (colon and rectum).

Why is this study being done on healthy people first?

Early studies like this are done in healthy volunteers to understand how a new medicine works in the body and if it's safe before trying it in people who have the condition.

What does 'bioequivalence' mean?

It means the study is comparing how much medicine the body absorbs and how quickly, under different conditions, like with or without food.

Will I get paid for taking part?

Many clinical trials offer some payment for your time and travel, but this would be confirmed by the study team.

What if I change my mind after joining?

You can withdraw from the study at any time, for any reason, without it affecting your healthcare or you needing to give an explanation.