A study testing the safety and effects of BAY 3018250 given as a single infusion in increasing doses in healthy men compared to placebo

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What is this study about?

This study is looking at a new treatment for acute ischemic stroke, which is a condition that happens when blood flow to part of the brain is suddenly blocked, usually by a blood clot. The study will test a medicine called BAY 3018250, which will be given through a drip into a vein, and some participants will receive placebo instead. The purpose of the study is to find out how safe the treatment is and how well it is tolerated when given in different doses to healthy men, and also to understand how the medicine moves through the body and what effects it has.

The study will give participants a single dose of BAY 3018250 starting at a low dose of 150 milligrams and increasing up to 1200 milligrams, or they will receive placebo. The medicine will be given as an infusion, which means it will slowly drip into a vein over a period of time. The study will check for any unwanted effects that might happen during or after the treatment, and it will measure the highest amount of medicine in the blood and how long it stays in the body.

This is the first time this medicine is being tested in people, so the study will only include healthy men between 18 and 45 years old. Participants will be randomly assigned to receive either the study medicine or placebo, and they will not know which one they are getting, though the study team will know. The study will track how participants feel and any side effects they may experience to help researchers understand if this treatment could be safe to test further in people who have had a stroke.

1 Receiving the study treatment

You will receive a single dose of either BAY 3018250 or placebo through an infusion, which means the medication will be given slowly into your vein.

The dose of BAY 3018250 may range from 150 mg to 1200 mg, depending on which group you are assigned to in the study.

A placebo is a substance that looks like the study treatment but contains no active ingredient. It is used for comparison purposes.

The treatment assignment is randomized, meaning it will be decided by chance, similar to flipping a coin.

The study is single-blind, which means you will not know whether you are receiving the active treatment or placebo, but the study staff will know.

2 Medical monitoring during the study

Your health will be monitored through various assessments throughout the study period.

These assessments include medical history review, physical examination, safety laboratory tests, vital signs measurement, and 12-lead electrocardiogram.

A 12-lead electrocardiogram is a test that records the electrical activity of your heart.

Vital signs include measurements such as blood pressure, heart rate, breathing rate, and body temperature.

Safety laboratory tests involve blood and urine samples to check how your body is responding to the treatment.

3 Safety evaluation

The study team will observe and record any treatment-emergent adverse events, which are any unwanted medical occurrences that happen after you receive the study treatment.

This includes monitoring for any side effects that may be related to BAY 3018250 or the placebo.

4 Pharmacokinetic and pharmacodynamic assessments

Pharmacokinetic assessments measure how the study treatment moves into, through, and out of your body over time.

This involves measuring the maximum concentration of the treatment in your blood and the total amount of the treatment in your blood over time.

Pharmacodynamic assessments measure what the study treatment does to your body and how it affects your body’s functions.

Who Can Join the Study?

You must be a man between 18 and 45 years old at the time you sign the consent form to join the study
You must be in good health, which will be checked through your medical history (information about your past health), a physical examination (a doctor checking your body), laboratory tests (blood and urine tests), vital signs (measurements like blood pressure, heart rate, and temperature), and a 12-lead electrocardiogram (a test that records the electrical activity of your heart)
Your body weight must be 65 kilograms or more, and your body mass index (a number calculated from your height and weight to show if you have a healthy body size) must be between 18.0 and 29.9 at the first visit
You must use contraception (methods to prevent pregnancy) that follows the local rules for men participating in medical studies

Who Cannot Join the Study?

Women cannot participate in this study, as it is only open to male participants
People who do not meet the specific age requirements for the study cannot participate
Individuals who are not healthy cannot participate, as this study is designed for healthy volunteers only
Anyone who has active medical conditions or serious health problems at the time of screening cannot participate
People who are taking certain medications that might interfere with the study drug cannot participate
Individuals with a history of allergic reactions to similar medications or any ingredients in the study drug cannot participate
People with abnormal laboratory test results or vital signs (such as blood pressure, heart rate, or temperature) that fall outside acceptable ranges cannot participate
Anyone who has participated in another clinical trial within a certain time period before this study cannot participate
Individuals who have donated blood or had significant blood loss recently cannot participate
People with a history of drug or alcohol abuse cannot participate
Anyone who smokes heavily or uses tobacco products excessively cannot participate
Individuals who are unwilling or unable to follow the study requirements and restrictions cannot participate

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Ces Ckxhobcn Rmtxlwuo Sxahqxlm Mygmjbacpo Glbc	Wuppertal	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	09.11.2022

Trial locations

Investigated drugs:

Bay 3018250

BAY 3018250 is an investigational medication being tested for the first time in humans. It is given as a single dose through an intravenous infusion, which means it is delivered directly into a vein. The purpose of testing this medication is to learn about its safety, how well it is tolerated by the body, how the body processes it, and what effects it has on the body.

Placebo is an inactive substance that looks like the real medication but contains no active ingredients. It is used as a comparison to help researchers understand the true effects of the investigational medication.

Acute Ischemic Stroke – Acute ischemic stroke occurs when blood flow to a part of the brain is suddenly blocked, usually by a blood clot in an artery. This blockage prevents oxygen and nutrients from reaching brain cells, causing them to become damaged or die within minutes. The condition develops rapidly and symptoms appear suddenly, including weakness or numbness on one side of the body, difficulty speaking or understanding speech, vision problems, dizziness, and severe headache. The affected areas of the brain determine which body functions are impaired. Brain tissue damage begins immediately after the blood supply is cut off and continues to worsen the longer the blockage remains. The extent of brain injury depends on the location and size of the blocked artery, as well as how quickly blood flow can be restored.

Trial ID:

2022-500505-41-00

Protocol code:

21751

Trial Phase:

Human Pharmacology (Phase I) – First administration to humans

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A study testing the safety and effects of BAY 3018250 given as a single infusion in increasing doses in healthy men compared to placebo

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?