AuthorisedHuman Pharmacology (Phase I)- First administration to humansInterventional

A First-in-Human Clinical Trial to Assess the Safety, Tolerability and Pharmacokinetics of MR-L45 in Healthy Adults

This study is a very early step in testing a new medicine called MR-L45. It's the first time this medicine is being given to people. Researchers want to make sure it's safe for healthy adults, understand any side effects, and see how the body handles it. This type of study, called a Phase 1 trial, is essential for all new medicines. The information gathered here will help decide if MR-L45 can be studied further for a kidney condition called Autosomal Dominant Polycystic Kidney Disease (ADPKD). ADPKD is a genetic condition where cysts grow in the kidneys. By studying MR-L45 in healthy volunteers, scientists hope to learn more about its potential to help patients in the future.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Mironid Limited

Enrolment target

Start

01 Apr 2026

Autosomal Dominant Polycystic Kidney Disease

What is this study about?

Imagine you have a jigsaw puzzle, and you're trying to find a new piece to complete it. This study is a bit like that, but for a new medicine. Scientists have created a new drug, which they've called MR-L45, and they want to understand how it works in people. This particular study is the very first time MR-L45 will be given to humans. It's a crucial early step for any new medicine.

The main goals of this study are to check if MR-L45 is safe, to see what dose people can handle without too many side effects (this is called 'tolerability'), and to learn how the body processes the medicine. This includes how it's absorbed, where it goes, and how it leaves the body. The volunteers for this first-in-human study will be healthy adults, meaning they don't have existing health conditions.

The bigger picture here is that researchers hope MR-L45 could eventually be useful for people with a condition called Autosomal Dominant Polycystic Kidney Disease (ADPKD). ADPKD is a long-term genetic condition where fluid-filled sacs, called cysts, grow in the kidneys, which can cause them to become enlarged and not work as well over time. While this study isn't directly treating ADPKD patients yet, the knowledge gained from healthy volunteers is vital before it can be considered for patients with the condition.

Key takeaways

This is a very early-stage study (Phase 1) of a new medicine, MR-L45.
It's the first time MR-L45 will be given to people.
The study focuses on safety, side effects, and how the body handles the medicine in healthy adults.
The research aims to eventually help people with a kidney condition called Autosomal Dominant Polycystic Kidney Disease (ADPKD).
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is looking for healthy adult volunteers. To take part, you must be 18 years old or older. There is no upper age limit, meaning people of all adult ages can be considered.

Both men and women are welcome to participate. The study team will check your general health to make sure you are suitable for this type of research.

Further specific health checks will be carried out by the study team to confirm if you are eligible to join, so please speak to them to find out more.

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?
Do you consider yourself a healthy adult?
Are you able to attend regular clinic visits?
Are you interested in helping medical research?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a full health check-up to make sure it's safe for you. Once enrolled, you would receive the new medicine, MR-L45. This study involves several visits to the clinic, which might include blood tests, urine tests, and other health assessments to monitor how your body is responding to the medicine.

The study team will carefully explain the schedule of visits and what each visit involves. This might include staying at the clinic for a short period after receiving the medicine for close monitoring. There will also be follow-up appointments to ensure your health is good after the study medicine has finished. The total duration of your participation will be clearly explained before you agree to take part.

Potential risks and benefits

Taking part in a study like this always has potential benefits and potential risks. A main benefit is contributing to medical science and helping to develop new treatments that could improve the health of others in the future, particularly those with Autosomal Dominant Polycystic Kidney Disease. As this is the first time the medicine is given to humans, there might be unknown side effects or discomfort. The study team will monitor you very closely for any reactions. You will be fully informed of all known risks before you decide to participate, and importantly, 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
Netherlands

Common questions

What is 'Phase 1' of a clinical trial?

Phase 1 is the very first step where a new medicine is given to people, usually healthy volunteers. The main goal is to check its safety and how the body handles it.

What is Autosomal Dominant Polycystic Kidney Disease (ADPKD)?

ADPKD is a genetic condition where fluid-filled sacs, called cysts, grow on the kidneys, which can affect how well they work over time.

Will I get better if I join this study?

This study is for healthy volunteers and is focused on safety, not on treating a disease. It's an important step for future treatments, but it won't directly treat ADPKD.

Will I be paid for taking part?

Some studies offer payment for your time and inconvenience, or cover travel expenses. You should ask the study team about this directly.

What's the medicine called MR-L45?

MR-L45 is the unique code name for the new medicine being tested in this study. It's not available outside of clinical trials.