A study to learn how safe the study treatment BAY2701250 is, how it affects the body and how it moves into, through and out of the body in healthy male participants when a single amount is given as an injection into the vein (intravenous infusion) or under the skin (subcutaneous injection).
This study is investigating a new medication, BAY2701250, designed for a specific type of high blood pressure in the lungs caused by heart problems. Researchers want to understand how safe this new medicine is, how it moves through your body, and how long it stays there. To do this, healthy male volunteers will be given a single dose of BAY2701250. This dose will be given either directly into a vein (like when you have blood taken) or as a small injection just under the skin. This important first step helps doctors learn about the medicine before it's given to people with the actual condition.
At a glance
What is this study about?
This study is exploring a new medicine called BAY2701250. It's intended for a condition called pulmonary hypertension that's linked to left heart disease. In simpler terms, this means that the blood pressure in the arteries leading to your lungs is too high because of an issue with the left side of your heart. When this happens, your heart has to work much harder to pump blood, which can lead to symptoms like shortness of breath and tiredness.
The main goal of this particular study is to learn a lot about how BAY2701250 works. Doctors want to find out if it's safe for people, how much of it gets into the body, how it travels around, and how quickly it leaves. This is a very early stage of testing a new medicine in humans, often called a 'Phase I' study. It's an important step because it helps to understand the basic safety and effects of the medicine before it can be tested in people who actually have the condition.
By understanding how the medicine behaves in healthy volunteers, researchers can decide on the right dose and how to give the medicine for future studies. This helps to make sure that when it is eventually given to patients with the condition, it will be as safe and effective as possible.
Key takeaways
- This study is testing a new medicine for lung and heart issues.
- It's an early-stage study focusing on safety and how the medicine works in the body.
- Only healthy men aged 18 and over are eligible.
- Participants receive a single dose, either by drip into a vein or an injection under the skin.
- Your participation helps to advance medical research for future treatments.
Who may be eligible?
To be considered for this study, you need to be a man and at least 18 years old. There's no upper age limit, but other health checks will be done.
This study is for healthy volunteers. This means you shouldn't have any significant ongoing health problems, especially with your heart or lungs, because the aim is to see how the new medicine works in a body that isn't already dealing with illness.
Doctors will perform a number of health checks and tests to make sure you are healthy enough to take part and that the study medicine won't harm you. They will explain exactly what conditions or medications would prevent you from joining.
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?
- Are you 18 years old or older?
- Are you generally healthy with no major ongoing medical conditions?
- Are you able to attend appointments at the study clinic?
What does participation involve?
If you decide to take part, you will be given a single dose of the study medicine, BAY2701250. This will be given either directly into a vein in your arm through a drip, or as an injection under the skin, similar to a routine vaccination. You will need to stay at the study clinic for a period of time after receiving the medicine so that the doctors and nurses can closely monitor you. They will take blood samples, measure your heart rate and blood pressure, and ask you how you are feeling to see how your body reacts to the medicine. There will likely be several follow-up visits or phone calls after you leave the clinic to check on your health and ensure the medicine has left your system. The total duration of your involvement will be clearly explained before you agree to participate.
Potential risks and benefits
Locations (1)
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Common questions
What is pulmonary hypertension due to left heart disease?
It's high blood pressure in the arteries that go to your lungs, caused by a problem with the left side of your heart.
Why are healthy men taking part in this study?
Healthy volunteers help doctors understand how a new medicine works and if it's safe at an early stage, before it's given to sick patients.
How will the medicine be given?
You'll receive a single dose either directly into a vein (like a drip) or as an injection under the skin.
Will I get paid for taking part?
Study centres often provide compensation for your time and travel, but this is something you should ask about directly.
What happens if I change my mind?
You can withdraw from the study at any time without giving a reason, and it won't 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
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