Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Phase 1 clinical trial to evaluate the safety, tolerability and pharmacokinetics of multiple daily doses of IM-250 in healthy volunteers.

This early-stage study, called a Phase 1 trial, is looking at a new medicine known as IM-250. Scientists want to understand if IM-250 is safe when healthy adult volunteers take it multiple times each day. They are also checking how well people tolerate the medicine (meaning, if it causes side effects) and how the body handles the medicine – how it's absorbed, how long it stays in the body, and how it's removed. Because this is the first time IM-250 is being given to people, the study focuses on making sure it's safe before it can be tested in patients who might eventually benefit from it.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Innovative Molecules GmbH

Enrolment target

Start

23 Apr 2025

Healthy Volunteers

What is this study about?

This study is about a new medicine called IM-250. It’s an early-stage research study, often called a 'Phase 1' study. The main goal of this kind of study is to see if a new medicine is safe for people to take. Researchers are giving IM-250 to healthy adult volunteers, not people with a specific illness, to carefully check for any side effects and how the body handles the medicine. This is a very important first step before the medicine can ever be given to patients.

During the study, participants will take IM-250 multiple times each day. The researchers will closely watch to see if there are any problems and how people feel. They will also collect samples, like blood, to understand how much of the medicine is in the body, how quickly it gets there, and how long it stays. This information helps them figure out the right amount of medicine to give in future studies.

The information gathered in this study will help decide if IM-250 can be tested further in larger groups of people, including those who could potentially benefit from it for a specific health condition in the future. It’s a crucial step in developing new treatments and ensuring they are as safe as possible.

Key takeaways

This is an early-stage study of a new medicine, IM-250.
It's for healthy adult volunteers to check safety and how the body handles the medicine.
Participants will take IM-250 multiple times daily.
Regular clinic visits, blood tests, and check-ups will be required.
You'll contribute to medical research, but there may be unknown risks.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for healthy adults. You must be at least 18 years old to take part. There is no upper age limit, meaning older adults are welcome to join if they meet all the other requirements.

Both men and women can participate in this study. The researchers want to include a wide range of healthy individuals to get a good understanding of how the new medicine behaves in different people.

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?
Do you consider yourself generally healthy?
Are you able to attend regular clinic appointments?
Are you comfortable taking a new medicine that's never been given to people before?
Are you willing to have blood tests and other medical checks?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be taking a new medicine called IM-250 multiple times each day for a set period. You would need to visit a clinic or hospital regularly for check-ups. These visits will involve various assessments, such as physical exams, blood tests, urine tests, and possibly other procedures like heart tracings (ECGs) to make sure you are well and to see how your body is reacting to the medicine.

After you finish taking the medicine, there will be follow-up visits to ensure your health remains good and to check for any lasting effects. The total duration of your involvement, from the first dose to the final follow-up, will be explained in detail before you agree to join.

Potential risks and benefits

The main benefit of taking part in this early study is helping science advance. You would be contributing important information that could lead to new medicines in the future. However, because IM-250 is a new medicine, there might be risks, including unknown side effects. Researchers will monitor you very closely for any changes. 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.

—
Unverified
Bulgaria

Common questions

What does 'healthy volunteers' mean?

It means people who generally don't have any major health conditions and are not taking regular medicines for an illness.

What does a 'Phase 1' study mean?

It's the very first time a new medicine is given to people. The main aim is to check if it's safe and how it works in the body.

Will I get paid for taking part?

Sometimes studies offer payment for your time and travel, but this varies. You should ask the study team directly.

What if I feel unwell during the study?

You will be closely monitored, and there will always be medical staff available to help if you feel unwell or have any concerns.

Can I leave the study at any time?

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