A study to test how well multiple doses of BI 765423 are tolerated by healthy men
This research study is inviting healthy men, aged 18 years and older, to take part. The main goal is to test a new medicine known as BI 765423. Because it's a very early-stage trial, called a 'Phase I' study, the focus is on understanding how safe the medicine is and how the body handles different amounts or 'doses' of it. We also want to see if there are any side effects. This study is purely for research purposes and is not designed to treat any health conditions. Participants will be closely monitored by a medical team to ensure their safety throughout the trial. It's an important step in developing new medicines, helping us learn more about potential treatments in the future.
At a glance
What is this study about?
This study is a very early test of a new medication called BI 765423. Think of it like taking the first few steps in developing a new car – before it can be driven on the road, engineers need to test individual parts and make sure they work safely. In medicine, this early testing is called a 'Phase I' study. The main purpose here is not to treat an illness, but to understand if the medicine is safe for people and what effect it has on the body.
We need healthy volunteers for this study so that we can accurately see what the medicine does without other health conditions making it difficult to understand the results. Participants will be given the medicine and carefully monitored by doctors and nurses. This helps us learn about things like how much medicine the body can cope with, how it's handled by the body, and if there are any side effects.
The information gathered from this study is crucial. It helps researchers decide if BI 765423 can safely move on to later stages of testing, where it might be given to people with specific health conditions to see if it actually works as a treatment. So, while it's not a treatment study itself, it's a vital part of finding potential new medicines for the future.
Key takeaways
- This is a very early-stage study (Phase I) of a new medicine called BI 765423.
- The main goal is to check how safe the medicine is and if it has any side effects in healthy people.
- The study is only looking for healthy men aged 18 and over.
- You will be closely monitored by medical staff throughout your participation.
- Participation will not directly benefit your health, but it contributes to future medical research.
Who may be eligible?
This study is looking for participants who are generally healthy. This means you shouldn't have any major ongoing health problems or serious illnesses that might affect how your body handles the study medicine or confuse the results.
To take part, you must be a man. We are looking for men who are 18 years old or older. There is no upper age limit, as long as you are considered generally healthy by the study doctor.
Since this is an early-stage study, the researchers need to be very careful to ensure the safety of participants. Therefore, they will check your medical history, perform a physical exam, and might do some blood tests to confirm you are healthy enough to participate.
- Are you a man?
- Are you 18 years old or older?
- Do you consider yourself generally healthy?
- Are you willing to attend regular appointments and be monitored closely?
- Are you able to manage any necessary stays at the study clinic?
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 will be given the study medicine, BI 765423, over a period of time. This will likely involve a number of visits to the study clinic, and you might need to stay overnight for some of them. During these visits, the study staff will conduct various assessments, which could include physical exams, blood tests, urine tests, and checking your heart rate and blood pressure regularly to see how you are reacting to the medicine.
You will be monitored very closely for any side effects or changes in your health. After you finish taking the medicine, there will likely be follow-up visits to ensure your health is still good and to collect any final information. The full duration of your participation, including all visits and follow-ups, will be clearly explained to you before you agree to join.
Potential risks and benefits
Locations (1)
- —Belgium
Common questions
What is BI 765423?
BI 765423 is a new investigational medicine that is being tested for the very first time in people. Its effects are not fully known yet.
Will this medicine treat any of my health problems?
No, this study is not designed to treat any health problems. It's purely for research to understand the safety of the new medicine.
Who can take part in this study?
This study is looking for healthy men who are 18 years old or older.
Do I have to pay to join the study?
No, you will not have to pay to be part of the study. All study-related care and medicines are provided free of charge.
What happens if I change my mind?
You are free to leave the study at any time, for any reason, even if you have already started. Your decision will not affect your future medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.