A study in healthy men to test how well different doses of BI 3821001 are tolerated
This study is an early-stage clinical trial, often called a Phase 1 trial. It is the very first time a new experimental medicine called BI 3821001 is being given to humans. Researchers want to learn how safe the medicine is, how well the body handles it, and what side effects it might cause at different dose levels. Because this is a safety test, researchers need healthy male volunteers aged 18 and older. Taking part helps doctors gather important early facts about how the medicine behaves in the human body. This step is essential before the drug can ever be tested in people who are unwell. Volunteers will be closely monitored by medical staff throughout the study to protect their safety and wellbeing. Taking part is completely voluntary, and you can stop at any time.
At a glance
What is this study about?
Before any new medicine can be used to treat patients, it must go through careful safety checks. This study is a Phase 1 clinical trial, which means it is the first time the new medicine, known as BI 3821001, is being given to people. The main goal is to test how safe it is and to see how the human body processes different amounts of the drug.
In studies like this, researchers usually start with very small doses. They carefully watch how participants feel and check for any unwanted side effects before slowly testing higher amounts in new groups of people. This helps doctors find the safest and most effective dose for future research. Because this is an early test, it does not aim to cure or treat any illness in the volunteers.
Healthy volunteers are crucial to this process. By studying people who do not have long-term health issues, researchers can see the direct effects of the medicine without other diseases or treatments confusing the results. The information gathered from this trial will help scientists decide whether BI 3821001 could become a helpful treatment for patients in the future.
Key takeaways
- This is a Phase 1 trial testing the medicine BI 3821001 in humans for the first time.
- The study focuses on safety, side effects, and how different doses affect the body.
- It is only open to healthy men aged 18 and older.
- Participants will be closely checked by doctors with tests and clinic visits.
- Taking part is voluntary, and you can leave at any time.
Who may be eligible?
This trial is looking for healthy men who are at least 18 years old. Because this is an early safety study, volunteers must be in good general health without any major medical conditions.
Women cannot take part in this specific study. You may also not be eligible if you have certain chronic health problems, take regular prescription medicines, or have allergies to ingredients in the trial drug. The study team will ask about your lifestyle and medical background to see if the trial is a safe match for you.
Before you can join, you will need to go through a full health check. This ensures that it is as safe as possible for you to take an experimental 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.
- I am a man aged 18 or older.
- I consider myself to be in good general health.
- I do not have major long-term illnesses or heart conditions.
- I am not currently taking regular prescription medicines.
- I am willing to attend clinic visits and have routine tests like blood samples.
What does participation involve?
If you decide to join, you will first attend a screening visit. The doctors will check your blood pressure, test your blood and urine, and take a trace of your heart rhythm (an ECG) to confirm you are in good health. If you are accepted, you will be given the study medicine, BI 3821001, at a specific dose. Depending on the trial plan, you may need to stay overnight at a specialist clinic so the medical team can watch you closely. During your stay, nurses will take regular blood samples to measure how much medicine is in your body and how quickly it leaves. After your treatment, you will have follow-up visits so doctors can check your recovery and make sure you feel well. The trial team will tell you the exact schedule and time commitment before you agree to join.
Potential risks and benefits
Locations (1)
- —UnverifiedGermany
Common questions
What is the main goal of this trial?
The goal is to find out if the new drug BI 3821001 is safe for humans and to discover what side effects it might cause at different doses.
Will taking part improve my health?
No. This trial is for healthy volunteers to test safety, so it does not provide any personal medical treatment or cure.
Do I have to pay to take part?
No, you do not pay. Healthy volunteer trials often cover travel costs and may offer compensation for your time and inconvenience.
Can I leave the study if I change my mind?
Yes. Taking part is completely voluntary, and you can withdraw at any time without any penalty.
Why are only men allowed in this trial?
Early trials often limit groups to keep results clear and to avoid any unknown risks to reproductive health until more is learned about the drug.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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