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

A study to learn how safe the study treatment BAY3401016 is, how it affects the body and how it moves into, through, and out of the body when a single amount is given to healthy male participants

This early-stage study is about a new potential medicine, BAY3401016, and it's the very first time it will be given to humans. We're looking for healthy male volunteers aged 18 and over to take part. Each participant will receive a single dose of the study medicine. Doctors will carefully monitor how safe it is, how the body reacts to it, and how it's absorbed, distributed, and eventually leaves the body. This information is really important because it helps scientists understand if this medicine might be helpful in the future for conditions like Alport syndrome, and what the right dose might be. It’s a crucial first step in developing new treatments.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Bayer AG

Enrolment target

126

Start

21 Apr 2023

Alport syndrome

What is this study about?

This study is about a very early stage of testing a new medicine called BAY3401016. Think of it like taking the first few steps with a new idea. This particular study is called a 'Phase 1' study, which means it’s the first time this medicine is being given to people, specifically healthy volunteers. The main goal is to understand if it's safe, and what happens once it's inside the body.

When we say 'how it affects the body,' we mean things like checking vital signs (blood pressure, heart rate), looking for any unexpected side effects, and generally making sure participants are feeling well. When we talk about 'how it moves into, through, and out of the body,' doctors will take blood and urine samples to see how the medicine is absorbed, how it travels around, and how quickly it's removed from the system. This helps them work out what a good dose might be and how often it might need to be taken in the future.

Even though this study isn't directly treating Alport syndrome right now, the information gathered is vital. Alport syndrome is a serious kidney condition, and finding new treatments is really important. By understanding this new medicine better in healthy people, researchers can decide if it's safe to move forward and test it in people with Alport syndrome in later studies. Every new medicine goes through these careful steps to ensure it’s as safe and effective as possible.

Key takeaways

This is a very early study of a new medicine, BAY3401016.
It's the first time this medicine will be given to people.
The study focuses on safety and how the medicine works in the body.
Only healthy men aged 18 and older can take part.
The information learned could help develop future treatments for Alport syndrome.

Who may be eligible?

This study is looking for volunteers who are healthy men. You need to be at least 18 years old to take part. There is no upper age limit mentioned, but you would still need to be considered generally healthy by the study doctors.

Being 'healthy' means that you don't have any significant medical conditions that would make taking part in the study unsafe. The study team will do a thorough health check to make sure you fit the criteria for being a healthy volunteer.

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 long-term health problems?
Are you able to stay at a study clinic for a few days if needed?
Are you comfortable with regular blood and urine tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have a screening visit. This is where doctors will check your health to make sure this study is right for you. If you qualify, you will likely stay at the study clinic for a few days so the team can give you a single dose of the study medicine and watch you closely. During your stay, they will take blood and urine samples regularly, measure your blood pressure and heart rate, and ask how you're feeling. After you leave the clinic, you may have a few follow-up visits or phone calls to make sure you're still doing well. The total time you would be involved in the study – from the first screening visit to the last follow-up – will be explained to you in detail.

Potential risks and benefits

Participating in any study has potential benefits and risks. A potential benefit is contributing to medical research that could eventually lead to new treatments for conditions like Alport syndrome. You might also receive careful medical monitoring during the study period. Potential risks include experiencing side effects from the study medicine, which could be mild or, less commonly, more serious. There's also the time commitment involved. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual 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 Alport syndrome?

Alport syndrome is a genetic condition that mainly affects the kidneys, leading to kidney disease. It can also cause problems with hearing and, in rare cases, eyesight.

Is this study actually treating Alport syndrome?

No, this study is about understanding a new medicine in healthy people. It's an early step to see if it's safe enough to eventually be tested in people with Alport syndrome in future studies.

Will I get paid for taking part?

Many early-stage studies offer compensation for your time and travel. This would be explained to you clearly if you are interested in joining.

What does a 'single amount' mean?

It means you will only receive one dose of the study medicine, not multiple doses over time.

What is a 'healthy participant'?

A healthy participant is someone who doesn't have any major ongoing health problems. The study doctors will do tests to confirm you fit this description.