CompletedPhase IInterventional

Deferred registration: NRG5051-102

Amyotrophic lateral sclerosis (ALS) is a form of motor neurone disease that damages nerve cells in the brain and spinal cord. Creating treatments for ALS can be difficult because medicines must be able to pass safely from the bloodstream into the brain to reach damaged cells. This Phase 1 clinical trial is looking at a new experimental medicine (named NRG5051). Rather than testing it in people who have ALS, researchers are inviting healthy adult volunteers aged 25 to 55 to take part. The main aim is to understand how the medicine travels through the body, how much enters the brain, and whether it causes any unwanted side effects. Because this is an early-stage study, full procedural details are currently held under a standard delayed release ('deferred registration') and will be published once initial trial steps are complete.

At a glance

Status

Completed

Phase

Phase I

Sponsor

NRG Therapeutics Ltd

Enrolment target

Start

04 Aug 2026

Estimated completion

30 Sep 2026

Assessment of blood/brain distribution of an IMP for Neurodegenerative Disease, specifically ALS (Amyotrophic Lateral Sclerosis) in healthy adults

What is this study about?

Amyotrophic lateral sclerosis (ALS) is a serious, progressive condition that affects the nerves responsible for movement. Over time, it causes muscles to weaken, making daily tasks like walking, talking, and breathing much harder. Scientists around the world are working to find new treatments that can slow down or stop this damage to nerve cells.

One of the biggest hurdles in treating brain diseases is something called the blood-brain barrier. This is a natural protective filter that shields the brain from harmful toxins and germs in the blood. However, it can also keep out helpful medicines. This trial is designed to see whether an experimental drug called NRG5051 can safely cross this barrier and reach the brain tissues where it is needed.

Because this is a Phase 1 trial, it is being tested in healthy volunteers first. Giving a brand-new medicine to healthy people helps doctors learn exactly how the human body handles it—such as how it is absorbed, broken down, and cleared—without the confusion of existing disease symptoms or other medications.

Some specifics about this trial are currently listed as 'deferred'. This is a normal practice in early medical research that temporarily keeps certain commercial and scientific details private while the study begins. Full details will be made public once this waiting period ends.

Key takeaways

Phase 1 trial testing a potential new medicine for motor neurone disease (ALS).
Open to healthy volunteers aged between 25 and 55 years old.
Aims to check how well the drug travels from the blood into the brain.
Healthy volunteers receive no direct medical benefit, but help advance MND research.
Full trial details are currently deferred and will be updated in the registry soon.

Who may be eligible?

This study is looking for healthy adult volunteers between the ages of 25 and 55. Both men and women can apply to take part. Because the goal is to see how the drug acts in a standard, healthy body, participants must not have ALS or any other significant long-term illnesses.

While the detailed exclusion checklist is currently kept under deferred registration, early-phase studies in healthy volunteers usually require that you do not smoke, do not drink heavy amounts of alcohol, and are not taking regular prescription medications that could interfere with the study drug.

If you express an interest in taking part, the research team will carry out health checks and go through a detailed questionnaire with you to make sure it is completely safe for you to join.

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.

I am between 25 and 55 years old.
I consider myself to be in good general health.
I do not have ALS or any other significant neurological conditions.
I am not currently taking regular prescription medications.
I am able and willing to attend all scheduled clinic visits and tests.

Answer every question to see your result.

What does participation involve?

Taking part in this study involves visiting a specialist clinical trial unit. Before anything starts, doctors will carry out screening tests—such as blood tests, heart traces (ECGs), and physical exams—to ensure you are in good health. You will then receive a dose of the study medicine. Because researchers need to measure how the drug moves into the brain and blood over time, you will have regular blood tests and possibly other monitoring checks. This may involve staying in the clinic overnight or attending several scheduled visits over a few weeks. The study team will follow up with you after your final dose to ensure you have had no lingering side effects, with the total study time typically lasting from several weeks to a few months.

Potential risks and benefits

Because you are taking part as a healthy volunteer, this trial will not provide you with any direct personal health benefits, though you will receive thorough medical checks. Your participation helps scientists discover whether this medicine could help future patients living with motor neurone disease. As with any new medicine, there is a risk of unexpected side effects, and routine procedures like blood tests can cause mild bruising or discomfort. You are completely free to leave the trial at any point, for any reason, without your normal medical care being affected.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Parexel EPCU (Early Phase Clinical Unit)
City only
London, England

Common questions

What is ALS?

ALS stands for Amyotrophic Lateral Sclerosis. In the UK, it is often called motor neurone disease (MND). It affects the nerves that control voluntary muscles, leading to muscle weakness over time.

Why is the trial recruiting healthy people instead of patients with ALS?

Phase 1 trials usually start in healthy volunteers to test the safety and movement of a drug in the body. This helps doctors find the right dose and spot side effects before testing it in people who are unwell.

What does 'deferred registration' mean?

It means the researchers have permission to delay publishing some scientific details of the study to protect confidential research ideas. The full information will be published once the deferral period expires.

Will I be paid for taking part?

Early-phase trials involving healthy volunteers often offer financial compensation for your time, travel expenses, and inconvenience. The trial team will explain this before you sign up.

Can I leave the study early if I change my mind?

Yes. Joining a clinical trial is entirely voluntary. You can withdraw your consent and leave at any time, and you do not have to give a reason.

How to find out more

Tunde Adebayo

harrowvolunteerfeedback@parexel.com +44 1895 694883 Official trial record

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