Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study to test how well multiple doses of BI 3810477 are tolerated by healthy adults.

This research study is inviting healthy adult volunteers to help us learn about a new medication called BI 3810477. The main goal is to find out if taking multiple doses of this medicine is safe and well-tolerated by the body. This is a very early-stage study, often called a 'Phase I' trial. It's crucial for understanding how the new medicine acts in the human body before it can be tested in people with specific illnesses. Your participation would help scientists understand potential side effects and how the medicine behaves, which is a vital step in developing new treatments.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Boehringer Ingelheim International GmbH

Enrolment target

Start

03 Apr 2025

Healthy volunteer trial

What is this study about?

Imagine a new medicine is being developed, designed to help people in the future. Before it can ever be given to someone who is unwell, doctors need to understand if it's safe to use. That's where studies like this one come in.

This particular study is looking for healthy volunteers – people who don't have any specific health problems at the moment. Its main aim is to give multiple doses of a new medicine, called BI 3810477, to these volunteers and carefully watch how their bodies react. The doctors want to see if there are any side effects, how the body handles the medicine, and what dose might be best.

This is a very early step in bringing a new medicine to patients. By taking part, you would be helping researchers gather important information about this new drug. This type of study is essential for making sure that any new treatment developed is as safe as possible for everyone.

Key takeaways

Tests a new medicine (BI 3810477) for safety in healthy people.
A very early-stage study (Phase I).
Requires healthy adult volunteers.
Involves multiple doses and close monitoring.
A vital step before new treatments can help sick people.

Who may be eligible?

To join this study, we're looking for adults who are generally healthy. This means you should be 18 years old or older, with no upper age limit, as long as you are considered fit and well by the study doctors after a health check.

Because this study is about understanding how the new medicine works in healthy people, you shouldn't have any major ongoing health problems. The study team will carry out a full health check-up to make sure you're suitable to take part.

Both men and women are welcome to participate. The important thing is that a doctor agrees you are healthy enough to join and that you meet all the other requirements of the study.

Quick self-check

Are you 18 years old or older?
Do you consider yourself generally healthy?
Are you willing to undergo health checks by doctors?
Are you able to attend clinic visits, potentially with overnight stays?

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 first have checks to ensure you're a good fit for the study. If you are, you would then receive doses of the study medicine, BI 3810477, over a period of time. This isn't a single dose; it involves taking the medicine more than once.

You would have several visits to the study clinic, and some of these might involve staying overnight, or for a few days, so the doctors and nurses can closely monitor you. During these visits, the study team would perform various assessments, such as blood tests, urine tests, and check your heart rate and blood pressure, to see how your body is responding to the medicine. There will also be follow-up appointments after your last dose to ensure everything is well. The total duration of your involvement, from your first screening visit to your final follow-up, will be explained in detail by the study team.

Potential risks and benefits

Participating in research always comes with potential benefits and risks. While there's no direct health benefit to you from taking this new medicine, your contribution is invaluable for helping develop future treatments for others. Potential risks might include side effects from the medicine, which will be carefully monitored, or discomfort from procedures like blood tests. 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 BI 3810477?

It's a new medicine that is being tested for the first time in people. We want to understand how it works and if it's safe.

Do I have to be sick to join this study?

No, quite the opposite! This study is specifically for healthy adults who don't have any major health problems.

What does 'multiple doses' mean?

It means you won't just take the medicine once. You will take it several times over a period, as guided by the study team.

Will I get paid for taking part?

Payment for your time and reimbursement for travel expenses are usually provided in early-stage studies like this. The study team will give you all the details.

What if I change my mind about participating?

You are free to leave the study at any time, even after you've started, without needing a reason and without it affecting your future care.