Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

(21751) First-in-human single dose escalation study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of BAY 3018250 in healthy men in a randomized, placebo-controlled, single-blind, group-comparison design

This is a very early study looking into a new medicine called BAY 3018250. The medicine aims to help people who have had a stroke. This study is the first time BAY 3018250 is being given to humans, specifically healthy men. Researchers want to make sure it's safe and to understand how the body deals with it. This includes seeing if there are any side effects and how much of the medicine stays in the body over time. Some men will receive the new medicine, and others will receive a dummy medicine (a placebo) to compare the effects, but they won't know which one they're getting.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Bayer AG

Enrolment target

Start

11 Oct 2022

Acute ischemic stroke

What is this study about?

This study is about a new medicine called BAY 3018250, which is being explored as a potential treatment for acute ischemic stroke. An ischemic stroke happens when a blood clot blocks blood flow to the brain, causing damage. Finding new and better treatments for stroke is very important because it can have serious long-term effects.

This is a 'first-in-human' study, which means it's the very first time this particular medicine is being given to people. At this stage, the main goal isn't to see if the medicine works to treat stroke but rather to make sure it's safe. Researchers will be carefully checking for any unwanted effects and seeing how the body takes in, processes, and gets rid of the medicine.

By understanding these early safety details, researchers can decide if it's safe to continue testing BAY 3018250 in larger studies with people who have actually had a stroke. This is a crucial step in developing any new medicine, helping to ensure that potential future treatments are as safe as possible.

Key takeaways

This is a very early safety study (Phase 1) for a new stroke medicine.
It's the first time this medicine, BAY 3018250, is being given to humans.
The study aims to check for side effects and how the body processes the medicine.
Only healthy men aged 18 and over can take part.
Participants will receive either the new medicine or a dummy medicine (placebo).
Close medical monitoring will be provided throughout the study.

Who may be eligible?

To join this study, current guidelines mean we are only looking for healthy men. You need to be at least 18 years old to take part; there isn't an upper age limit specified, providing you are otherwise healthy.

The study is designed for healthy volunteers, not people who have had a stroke or other serious health conditions. This is because it's the first time the medicine is being tested in humans, and researchers want to understand its effects without any other health issues complicating the results.

More detailed checks will happen if you express an interest, to make sure you meet all the health requirements to take part safely.

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 male?
Are you 18 years old or older?
Are you generally in good health?
Have you spoken to your doctor about joining a trial?

Answer every question to see your result.

What does participation involve?

If you join this study, you would receive either the new medicine, BAY 3018250, or a placebo (a dummy medicine that looks the same but contains no active drug). You wouldn't know which one you received, nor would the doctors giving it to you, to ensure fair results. The medicine would be given as a single dose.

Throughout the study, you would have several visits to the clinic. During these visits, doctors and nurses would perform various checks. This includes regular blood tests to see how your body is handling the medicine and to check for any changes. They would also monitor your vital signs, like blood pressure and heart rate, very closely. The main focus will be on carefully watching for any side effects or uncomfortable feelings you might experience. The total duration of your participation, including all visits and follow-up, would be fully explained before you agree to take part.

Potential risks and benefits

Taking part in any clinical trial involves both potential benefits and potential risks. A potential benefit to you personally is contributing to medical research that could one day help people affected by stroke. However, because this is a very early-stage study, it's not designed to directly improve your health but rather to test the safety of a new medicine. There are potential risks, as with any new medicine, including unknown side effects that could range from mild to more serious. You would be carefully monitored, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany

Common questions

What is a 'first-in-human' study?

It means this is the very first time this new medicine is being given to people. Its main purpose is to check for safety and how the body handles the medicine.

Why are only healthy men being included?

Because it's the first time the medicine is being tested in people, using healthy men helps researchers understand the basic effects of the medicine without other health conditions making things more complicated.

What is a placebo?

A placebo is a 'dummy' medicine that looks exactly like the real medicine but contains no active drug. It's used for comparison to see the true effects of the new medicine.

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

No, neither you nor the study staff will know which you are receiving. This is called 'single-blind' and helps ensure the study results are fair and unbiased.

What are 'side effects'?

Side effects are any unexpected or unwanted reactions to a medicine. In this study, doctors will be carefully looking for and recording any side effects you might experience.