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

A clinical trial to determine if AIC263029 is safe when dosed only once or several times, and to investigate how it moves within the human body

This is an early phase clinical trial looking at a new medicine called AIC263029. It’s the very first time this medicine will be given to people. The main goal is to check if it's safe when taken once or several times. Researchers also want to understand how the body handles the medicine – how it’s absorbed, where it goes, and how it leaves the body. This particular medicine is being developed to help people with a kidney problem called BKV-associated nephropathy, which can affect people who have had kidney transplants. Studying how the drug works in healthy people first helps us understand it better before it's given to patients with the condition.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

AiCuris Anti-infective Cures AG

Enrolment target

104

Start

15 Mar 2024

BKV-associated nephropathy

What is this study about?

This study is an early step in developing a new medicine, called AIC263029. When a new medicine is created, it goes through several stages of testing. This particular study is what we call a 'Phase I' trial. This means it's one of the very first times the medicine will be given to people, not just in a lab.

The main purpose of this study is to find out two key things: Firstly, is AIC263029 safe? We need to know if there are any unwanted effects when healthy people take it, either once or a few times. Secondly, we want to understand how the medicine behaves inside the human body. This includes how it's absorbed after being taken, how it circulates, where it goes, and how quickly the body gets rid of it. This information is really important for doctors to know the right amount of medicine to give and how often.

This new medicine is being developed to help treat a specific kidney problem called BKV-associated nephropathy. This condition can sometimes affect people who have had kidney transplants, causing problems with their new kidney. By studying how AIC263029 works in healthy people first, scientists can gather important safety and dosing information before giving it to patients with the actual condition. This careful step-by-step approach helps ensure that new treatments are as safe and effective as possible.

Key takeaways

This is an early study of a new medicine called AIC263029.
The main goals are to check how safe it is and how it moves through the body.
It's being developed for a kidney condition called BKV-associated nephropathy.
Participants must be 18 years old or older, and healthy.
This study aims to gather important information for future patient treatments.

Who may be eligible?

To take part in this study, you need to be an adult, 18 years old or older. There is no upper age limit, meaning people of any adult age can be considered. The study is open to both men and women.

Because this is a very early study and the medicine is new, it's typically looking for healthy volunteers. This is so researchers can understand how the medicine works on its own, without other health conditions making things complicated. They will do health checks to make sure you are suitable.

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 18 years old or older?
Are you generally healthy?
Are you comfortable potentially taking a new, untested medicine?
Are you happy to attend multiple clinic visits and have regular tests?
Are you able to follow study instructions carefully?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would first have a screening visit to check if you are healthy enough for the study. This might include blood tests, a physical exam, and other checks. If you qualify, you would then receive the study medicine, AIC263029. This could involve taking it once or several times over a period. You would have regular visits to the clinic for doctors and nurses to monitor your health, check for any side effects, and take samples (like blood or urine) to see how the medicine is working in your body. The exact number of visits, tests, and the total time you spend in the study would be fully explained before you agree to take part.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is contributing to scientific knowledge that could lead to new treatments for kidney conditions like BKV-associated nephropathy. However, as this is a new medicine, there might be unknown side effects or risks. You could experience discomfort from medical procedures or from the study medicine itself. You will be closely 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.

—
Unverified
Germany

Common questions

What is BKV-associated nephropathy?

It's a kidney problem that can sometimes happen in people who have had a kidney transplant, which can harm the new kidney.

Why test this medicine on healthy people first?

Testing on healthy volunteers helps us understand how the new medicine works and if it's safe, without other health problems complicating the results.

What does 'Phase I' mean?

Phase I is the earliest stage of human testing for a new medicine. It mainly focuses on safety and how the body handles the drug.

Will I get better if I join this study?

This study is not designed to treat a disease, but to gather information about a new medicine's safety and how it works in the body. You would need to be healthy to participate.

How long will the study last if I join?

The information above doesn't say, but the study team will explain the full time commitment for visits and follow-up during the screening process.