Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study to Learn How Safe AGMB-129 is in Healthy Adults Taking Multiple Doses of AGMB-129 That Are Increased a Little at a Time

This study is designed to learn about the safety of a new medication called AGMB-129. It's for people with a type of Crohn's disease that causes narrowing and blockages in the gut, known as fibrostenotic Crohn's. However, this first phase of the study is recruiting healthy adults, not patients. They will receive small, increasing doses of AGMB-129. This helps researchers understand how the medication behaves in the body and if it causes any side effects at different dose levels. It's a very early stage of research, focusing purely on safety before it can be tested in patients who actually have Crohn's.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Agomab Spain S.L.U.

Enrolment target

Start

26 Jun 2025

Fibrostenotic Crohn’s disease

What is this study about?

This study is looking into a new medicine, AGMB-129, for a specific type of Crohn's disease. Crohn's disease is a condition that causes inflammation in the digestive system. The type of Crohn's this medicine hopes to treat is called 'fibrostenotic Crohn's'. This is when the inflammation causes parts of the gut to become narrow and possibly blocked.

Because AGMB-129 is a new medicine, researchers need to be very careful. This first part of the study is a 'Phase 1' trial, which means its main purpose is to check how safe the medicine is. For this study, they are giving AGMB-129 to healthy adults, not people with Crohn's disease. This is a common and important step in developing new medicines.

Healthy volunteers will be given small, gradually increasing amounts of AGMB-129. By doing this, the researchers can see if the medicine causes any problems or side effects at different dose levels. This helps them understand how the medicine works in the body and if it's safe enough to eventually test in people who actually have fibrostenotic Crohn's disease.

Key takeaways

New medicine (AGMB-129) being tested for a type of Crohn's disease.
This first study is purely about safety, using healthy adults.
Participants will receive small, increasing doses of the medicine.
Regular health checks are part of the study.
Your contribution helps develop new treatments for others.

Who may be eligible?

To join this study, you need to be an adult, 18 years old or older. There is no upper age limit, meaning older adults can also take part.

Both men and women are welcome to participate in this research, as the study aims to understand how the medication affects everyone.

Crucially, this study is for healthy individuals. This means you should not have any serious or long-term health conditions. The researchers will check your health carefully 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 18 years old or older?
Are you generally healthy, without any serious or long-term medical conditions?
Are you comfortable with regular health check-ups and blood tests?
Are you able to commit to the study's schedule of appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study medication, AGMB-129. You would start with a small dose, and this dose would be slowly increased over time according to the study plan. You would have regular visits to the clinic for health checks, which might include blood tests, urine tests, and monitoring of your vital signs like blood pressure and heart rate. These checks are to make sure you are healthy and to see how your body is reacting to the medication. The study team will explain the exact schedule of visits and what each visit involves. The total duration of your participation would be explained during your consultation, including any follow-up after the last dose.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. For healthy volunteers in this type of early study, the main benefit is contributing to medical science and helping to potentially develop a new treatment for Crohn's disease. There is no direct personal health benefit for you. Potential risks could include side effects from the medication, which the researchers will carefully monitor. 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 fibrostenotic Crohn's disease?

It's a type of Crohn's disease where inflammation causes parts of the gut to narrow and potentially become blocked.

Why is this study using healthy adults?

It's a first step to check if the new medication (AGMB-129) is safe and how it works in the body before testing it in patients.

Will I get better if I join this study?

This study is for healthy volunteers, so it won't treat any existing illness you have. The aim is to gather safety information.

What kind of checks will I have?

You'll have regular health checks, which may include blood tests and monitoring of your heart rate and blood pressure.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time without needing to give a reason, and it won't affect any future medical care.