RecruitingPhase IInterventional

Phase I trial code: RD 787.36057 (MTX325-101)

This study is a Phase 1 clinical trial evaluating an experimental treatment known by the code MTX325-101. Phase 1 trials are the first stage of testing a new treatment in people. Their main goal is to check safety, find the right dose, and see how the human body processes the medicine. Full details about the exact condition and the medicine are not yet published. The UK Health Research Authority (HRA), which oversees health research to protect participants, has formally approved keeping these details private for now. Complete information will be made public within 30 months of the study ending. The trial is open to men and women aged 18 to 75. Anyone invited to take part will receive a detailed patient information sheet explaining all aspects of the study before agreeing to join.

At a glance

Status

Recruiting

Phase

Phase I

Sponsor

Mission Therapeutics Ltd.

Enrolment target

158

Start

06 Feb 2024

Estimated completion

16 Jul 2027

The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended.

What is this study about?

This clinical trial is evaluating a new experimental treatment with the code name MTX325-101. It is a Phase 1 trial, which means researchers are testing the medicine in humans for the first time or in a brand-new way. These early studies are essential for discovering whether a treatment is safe to use, how well it is tolerated, and what dose works best.

You might notice that specific information—such as the condition being treated and the exact type of medicine—is not publicly listed. In the UK, the Health Research Authority (HRA) can grant permission to delay releasing full study details to the public. This often happens to protect early scientific discoveries or commercial development. Even though the public record is limited, the trial has gone through rigorous ethical reviews to ensure participant safety.

Early research of this kind is vital for medical progress. Every modern medicine we rely on today had to begin in a Phase 1 study. Full results and background details about this trial will be added to the public register within 30 months after the study is completed.

Key takeaways

Phase 1 trial testing an experimental treatment known as MTX325-101.
Open to adults aged between 18 and 75.
Detailed public information is temporarily delayed with official approval from the Health Research Authority.
Full trial information will be published within 30 months after the trial finishes.
Participation is entirely voluntary, and participants are closely monitored by doctors.

Who may be eligible?

The trial is open to adults aged between 18 and 75 years, including both men and women.

Because the study details are currently deferred by the research authorities, specific health requirements and exclusion rules have not been published. Usually, Phase 1 trials require participants to either be healthy volunteers or have a specific health condition that the researchers are aiming to treat.

If you are being considered for this study, the research team or your doctor will check your medical history in detail. They will explain whether your personal health status matches the requirements before you decide to take part.

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.

You are aged between 18 and 75 years old.
You are comfortable attending regular hospital or clinic appointments for monitoring.
You are willing to have routine health checks, such as blood tests and heart scans.
You are happy to discuss your full medical history with the research team.

Answer every question to see your result.

What does participation involve?

Taking part in a Phase 1 study typically involves an initial screening visit where doctors check your overall health through blood tests, heart traces (ECGs), and physical exams. If you join, you will receive the study treatment under close medical observation at a specialist clinic or hospital unit. You can expect frequent monitoring visits, regular checks of your vital signs, and blood samples to see how your body breaks down the medicine. The research team will track your health throughout the treatment and for a follow-up period afterwards. Your study team will give you an exact schedule showing how long the trial will last and how many clinic visits are required.

Potential risks and benefits

Because this is an early-stage trial, you may not receive any direct medical benefit from taking part, though your participation could help develop important treatments for others in the future. As with any new medicine, there is a risk of unexpected side effects, which is why participants are watched very closely by medical staff. Taking part is completely voluntary. You have the right to withdraw from the trial at any time, for any reason, without it affecting your usual healthcare in any way.

Locations (1)

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

Simbec Research Limited
City only
Mid Glamorgan, Wales

Common questions

Why are the full details of this trial not shown?

The UK Health Research Authority has agreed to delay publishing full details to protect early research data. Full details will be published within 30 months after the trial ends.

Has this study been checked for safety?

Yes. Even though public details are delayed, the study must be reviewed and approved by an independent UK Research Ethics Committee before any patient can join.

Will I be told what the medicine is before I join?

Yes. If you are invited to participate, the study team must give you full, clear information about the treatment and what to expect before you agree to take part.

Can I leave the study if I change my mind?

Yes. You can leave the trial at any point without giving a reason, and your regular NHS medical care will not be affected.

Will I have to pay to take part?

No. Clinical trials in the UK do not charge participants. In many cases, travel expenses are reimbursed, and some Phase 1 trials offer compensation for your time.

How to find out more

Sarah Fritchley

sfritchley@missiontherapeutics.com +44 (0) 7462 135809 Official trial record

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