Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study to test how well healthy people tolerate spesolimab when given in 2 different ways.

This research is looking at a new medicine called spesolimab. It's being tested in healthy people to see how they react to it. The main goal is to check its safety and how well people tolerate it when given in two different ways. This is a very early stage of testing, sometimes called a Phase 1 study, where scientists learn more about new medicines. It's not about treating a disease yet, but about understanding the medicine itself. The information gathered will help decide if spesolimab can be studied further for potential future uses in patients. Participants must be 18 years or older.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Boehringer Ingelheim International GmbH

Enrolment target

Start

17 Jul 2024

Healthy volunteer trial

What is this study about?

This study is about a new medicine called spesolimab. When a new medicine is developed, it goes through several stages of testing to make sure it's safe and effective before it can be used to treat patients. This particular study is one of the very first steps in that process.

The main aim of this study is to understand how spesolimab behaves in the human body. Researchers want to see how well healthy people tolerate it when it's given in two different ways. This helps them learn about potential side effects and the best way to give the medicine. It's important to remember that this study is not designed to treat any illness; it's purely to gather information on the medicine's safety and how the body handles it.

By taking part, healthy volunteers play a crucial role in medical research. The information collected from this kind of study helps scientists decide if the medicine is safe enough to move on to later stages of testing, where it might be given to people with specific health conditions that it's designed to treat. Your participation helps pave the way for potential future treatments.

Key takeaways

This study is testing a new medicine called spesolimab in healthy people.
It's a very early-stage study focused on safety and how well people tolerate the medicine.
Participation involves receiving the medicine and having health check-ups.
You must be at least 18 years old to join.
Your involvement helps advance medical research for future treatments.

Who may be eligible?

To join this study, you need to be a healthy adult. This means you generally don't have any major ongoing health problems or take regular medication that could affect the study results.

Both men and women are welcome to take part. The most important age requirement is that you must be at least 18 years old. There's no upper age limit mentioned, so older adults who are otherwise healthy may also be able to join.

The research team will carry out several checks to make sure you're healthy enough to participate safely. This is to protect your well-being and to ensure the study results are clear and accurate.

Quick self-check

Are you 18 years old or older?
Do you consider yourself generally healthy?
Are you able to attend regular appointments for health checks?
Are you comfortable receiving a new, untested medicine?
Are you willing to have blood tests and physical exams?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you would receive the study medicine, spesolimab, in one of two different ways as decided by the study team. You would have regular appointments with the study doctors and nurses, which would involve physical examinations, blood tests, and possibly other tests to check your health and how your body is reacting to the medicine. The research team will explain how many visits are needed, how long each visit will be, and the total duration of your involvement in the study, including any follow-up appointments after you've stopped taking the medicine.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit is contributing to medical science, helping to understand new medicines which could lead to future treatments for others. However, as this is an early stage study, it's not expected to directly benefit your health. Potential risks include experiencing side effects from the study medicine, which will be carefully monitored by the research team. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

—
Belgium

Common questions

What is spesolimab?

Spesolimab is a new medicine that researchers are studying. This particular study is in the very early stages, looking at its safety in healthy people, not to treat any illness yet.

Why are you testing it on healthy people?

We test new medicines on healthy people first to understand how they work in the body and to check for any early side effects before we consider using them in people who are unwell.

Will I get better if I join this study?

This study is not designed to treat any particular illness, so you won't 'get better' in that sense. Its purpose is to gather information about the medicine's safety.

What does 'tolerability' mean?

Tolerability means how well your body copes with the medicine, particularly looking for any side effects or discomfort you might experience.

Will I have to pay to be in the study?

No, you will not have to pay to participate in the study. All study-related care and medicine will be provided free of charge.