RecruitingPHASE1INTERVENTIONAL

A Study in Healthy Men to Test How Well Different Doses of BI 3821001 Are Tolerated

This study is for healthy men aged 18 to 55. It's an early-stage study testing a new medicine called BI 3821001. The main goals are to check if the medicine is safe, if different doses are well-tolerated, and how the medicine moves through and out of the body. Participants will receive either the new medicine or a dummy medicine (placebo). This is a 'Phase 1' study, which means it's one of the first times the medicine is being tested in people. The information gathered will help researchers understand if it's safe to study this medicine further for potential future uses.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Boehringer Ingelheim

Enrolment target

Start

22 Apr 2026

Estimated completion

02 Oct 2026

Healthy

What is this study about?

This research is focused on understanding a new medicine called BI 3821001. Scientists are giving it to healthy men to learn basic but very important information. Think of it like a very early test drive for a new car; they need to make sure it's safe and performs as expected before taking it on longer journeys.

The main things researchers want to find out are: First, is the medicine safe? They'll carefully monitor participants for any unwanted effects. Second, how well do people tolerate different amounts (doses) of the medicine? This helps them work out the best dose to use in the future. Third, they will study how the medicine behaves in the body – how it's absorbed, distributed, broken down, and removed. This is often called studying the 'pharmacokinetics'.

This is a 'Phase 1' study, meaning it's one of the very first times this medicine is being tested in humans. Studies like this are a crucial step in developing new medicines. The information collected here will help shape future research and determine if the medicine is promising enough to be studied in people who have a particular illness.

Key takeaways

Tests a new medicine (BI 3821001) in healthy men.
Aims to check safety, tolerability, and how the body handles the medicine.
Participants will receive either the new medicine or a dummy medicine (placebo).
Only for healthy men aged 18-55 with a specific Body Mass Index (BMI).
It's a 'Phase 1' study, which is an early stage of drug development.
Your health will be closely monitored throughout your participation.

Who may be eligible?

To join this study, you need to be a healthy man, aged between 18 and 55. Your weight in relation to your height, known as your Body Mass Index (BMI), should be between 18.5 and 29.9. You'll have a full health check-up, including a look at your medical history, a physical exam, and some basic tests, to make sure you are healthy enough to take part.

There are also some reasons why you wouldn't be able to join. For example, if your health check-up or tests show anything outside the normal range that a doctor thinks is important to your health, you wouldn't be able to participate. This includes things like blood pressure, pulse, or certain blood test results that are too high or too low.

Also, if you have any existing medical conditions that a doctor considers significant, or if your blood pressure or pulse fall outside specific ranges, you wouldn't be eligible. The aim is to ensure all participants are truly healthy to get the clearest possible results about the new medicine.

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 a man aged between 18 and 55?
Do you consider yourself generally healthy?
Do you have a Body Mass Index (BMI) between 18.5 and 29.9?
Are you comfortable with having medical check-ups, blood tests, and ECGs?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be given either the new medicine (BI 3821001) or a dummy medicine (placebo). You won't know which one you're getting, and neither will the study team, to keep the results fair.

Throughout the study, you'll have several visits for check-ups. These will include physical examinations, measuring your blood pressure and pulse, having electrocardiograms (ECGs) which check your heart's electrical activity, and blood tests. These tests help the doctors monitor your health and how your body is reacting to the medicine. The study will last for a specific period, covering the time you receive the medicine and a follow-up period to ensure you're well afterwards. More detailed information about the exact number of visits and the full duration of your participation would be given by the study team.

Potential risks and benefits

Participating in research always involves potential benefits and risks. A potential benefit is contributing to medical science, which could lead to new treatments for others in the future. You will also receive careful medical monitoring throughout the study. However, there are potential risks, including side effects from the study medicine, some of which might not be known yet. There's also the inconvenience of time commitment and frequent medical procedures. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

CRS Clinical Research Services Berlin GmbH
Verified postcode
Berlin, Germany· Recruiting

Common questions

What is BI 3821001?

It's a new medicine that is being tested for the first time in people during this study. Its full purpose isn't yet known, as this study is about its safety and how the body handles it.

What does 'healthy men' mean in this study?

It means men who don't have any significant medical conditions and are generally in good health, as confirmed by medical checks and tests.

What is a placebo?

A placebo is a dummy medicine that looks exactly like the real medicine but contains no active drug. It helps researchers compare the effects of the active medicine fairly.

Will I know if I'm getting the medicine or the placebo?

No, this is a 'blinded' study, meaning neither you nor the study doctors will know who is getting the active medicine and who is getting the placebo. This helps make the study results more reliable.

Why is this study only for men?

Early-stage studies sometimes focus on one gender to carefully understand the medicine's effects before potentially expanding to include women later on. This is common practice in initial drug development.

How to find out more

Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com 1-800-243-0127 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.