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RecruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

A study investigating the safety, tolerability, pharmacokinetics (absorption, distribution, metabolism and elimination) and effect of single and multiple doses of MTX46943, a new compound that may potentially be used in the treatment of Alzheimer’s disease and other neurological disorders

Alzheimer’s disease is a condition that gradually affects memory, thinking, and daily life. Researchers are working hard to discover new treatments, and this early-stage clinical trial is looking at an experimental medicine called MTX46943. This is a 'Phase 1' study, which means it is the very first time this medicine is being given to humans. Because of this, the main goal is not to cure Alzheimer's disease right away, but to find out if the medicine is safe to use. Doctors want to see how the human body absorbs, breaks down, and clears the medicine after single or repeated doses. The trial is open to adults aged 18 and over. While taking part might not directly improve your own health, the information gathered will help scientists decide whether this medicine should be tested in larger studies for people with neurological conditions.

At a glance

Status
Recruiting
Phase
Human Pharmacology (Phase I)- First administration to humans
Sponsor
Muna Therapeutics ApS
Enrolment target
123
Start
04 Sep 2025

What is this study about?

Alzheimer’s disease causes changes in the brain that make it difficult to remember things, communicate, and look after oneself. While there are some medicines available to help manage symptoms, scientists are constantly searching for new treatments that might protect brain cells and slow down the disease.

This clinical trial is testing an experimental medicine called MTX46943. It is designed to target processes in the brain that may play a role in Alzheimer’s disease and other nervous system conditions. Before any new medicine can be offered to the public, it must go through careful testing to ensure it works properly and does not cause unexpected harm.

Because this is a 'first-in-human' study, doctors are focusing entirely on safety. They will look closely at what happens when volunteers take a single dose, as well as when they take doses over several days. They will also measure how much medicine enters the blood and how quickly the body gets rid of it. The findings from this trial will build the foundation for future studies.

Key takeaways

  • This trial is testing a new drug called MTX46943 in humans for the very first time.
  • The primary focus is checking safety and how the human body processes the medicine.
  • The study is open to adults aged 18 and older of all genders who meet specific health checks.
  • Participants will receive comprehensive health monitoring throughout the trial.
  • Taking part is entirely voluntary, and you can withdraw at any time.

Who may be eligible?

This study is open to adults aged 18 and older, and both men and women may be able to join. Because it is an early-stage safety study, participants will need to meet strict health criteria before they can take part.

The study team will run several routine health checks to ensure it is completely safe for each person to receive the medicine. People with certain serious medical conditions, or those taking specific medications that could interact with the trial drug, may not be able to join.

If you are interested, the trial doctors will review your complete medical history and discuss the exact requirements with you to see if the study is a good match.

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.

  1. You are aged 18 or older
  2. You are willing to attend scheduled appointments and health checks
  3. You are comfortable having regular blood tests and heart checks (ECGs)
  4. You are prepared to potentially stay overnight at a clinical research clinic
  5. You are happy to discuss your full medical history and current medicines with the trial team
Answer every question to see your result.

What does participation involve?

Taking part in this study involves close medical monitoring. You will first attend a screening visit where doctors check your overall health using blood tests, heart tracings (ECGs), and physical examinations. If you are eligible, you will receive the study medicine, either as a single dose or as multiple doses over a set period. Depending on the study plan, you may be asked to stay overnight at a specialist clinical research unit so doctors can monitor you around the clock. The team will take regular blood and urine samples to measure medicine levels and check for any side effects. After finishing your doses, you will have follow-up visits or phone calls to make sure you are feeling well. The entire study typically lasts from several weeks to a few months.

Potential risks and benefits

Because this medicine is being given to humans for the first time, there is a risk of side effects that doctors cannot fully predict. However, you will be monitored very closely in a safe hospital or research unit, and medical staff are trained to deal with any problems immediately. You are unlikely to gain any direct personal health benefits from joining, but your participation helps scientists learn how to develop better treatments for Alzheimer's disease in the future. Taking part is completely voluntary, and you are free to leave the trial at any time without giving a reason and without it affecting your standard NHS 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 does a Phase 1 trial mean?

A Phase 1 trial is the first step in testing a new medicine in people. It focuses on finding out if the drug is safe, what the right dose might be, and how the body handles it.

Will this medicine cure my Alzheimer’s disease?

No, this study is not designed to cure Alzheimer's disease. Its main aim is to test the safety of the medicine rather than treat or cure the condition directly.

Do I have to pay to take part?

No. Clinical trials in the UK do not charge you to take part. Study medicines and tests are provided free, and travel expenses are often reimbursed.

Can I leave the study if I change my mind?

Yes. You have the right to withdraw from the trial at any point, for any reason, and your regular medical care will not be affected in any way.

Will I need to stay in a clinic overnight?

Many early-stage trials require short stays in a research unit so medical staff can take regular blood samples and monitor your safety closely. The team will explain this before you join.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A study investigating the safety, tolerability, pharmacokine…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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