RecruitingPhase IInterventional

Phase 1 Trial: 36024 (SYX-5219-101)

This clinical trial, known as SYX-5219-101, is a 'Phase 1' study. This means it's one of the very first times a new potential treatment is being tested in people. The main purpose of Phase 1 trials is to see if the treatment is safe and to figure out the right dosage, rather than to see if it cures a condition. Information about the specific health conditions it aims to treat, what the treatment involves, and who can or cannot join isn't available yet. The full details will be released in about two and a half years after the trial finishes. For now, we know it's open to adults between 18 and 65 years old, of any gender.

At a glance

Status

Recruiting

Phase

Phase I

Sponsor

Sitryx Therapeutics Ltd.

Enrolment target

149

Start

26 Feb 2025

Estimated completion

30 Jun 2026

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 study is a 'Phase 1' clinical trial. Think of new medicines going through several testing stages, much like a product goes through different levels of quality control before it's sold. Phase 1 is the very first stage where a new treatment is tried in humans. The main goal at this point isn't to see if it cures a disease, but to check whether it's safe and to find out the best dose to use.

Because this is such an early stage, many specific details about the study are being kept private for now. This is a normal part of the research process, and it allows the researchers to complete their work before sharing everything. The organisation that oversees health research in the UK (the Health Research Authority) has agreed to this temporary delay. All the information will be made public within 30 months (about two and a half years) after the study has officially ended.

Even though many details aren't publicly available yet, we do know it's open to adults aged 18 to 65. The study is referred to by a code: 36024 (SYX-5219-101). Once the full details are released, we'll learn more about the specific health conditions it's investigating and exactly what the 'intervention' (the new treatment) involves.

Key takeaways

This is a Phase 1 study, the earliest stage of human testing.
The main goal is to check the safety of a new treatment (SYX-5219-101) and find the best dose.
Full details about the specific condition and what's involved are currently not public.
Participants must be aged 18 to 65 years old.
All missing information will be released within 30 months after the trial ends.
Taking part means contributing to future medical knowledge.

Who may be eligible?

Currently, the full information about who can and cannot join this study isn't available to the public. This means we don't know the specific health conditions or other medical details that might make someone suitable or unsuitable for this trial.

However, we do know that participants must be adults. The study is looking for people aged between 18 and 65 years old.

Once the full details are released by the researchers later on, we will have a clearer picture of the other requirements and restrictions for taking 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.

Am I aged between 18 and 65 years old?
Am I comfortable with not knowing all the study details upfront?
Do I understand that this is a very early, safety-focused trial?
Am I willing to potentially undergo various medical tests and appointments?

Answer every question to see your result.

What does participation involve?

Because the full details of this study are not yet public, we can't tell you exactly what taking part would involve. Generally, in a Phase 1 trial like this, participants might have several hospital or clinic visits. These visits often include checks like blood tests, physical examinations, and possibly scans to see how their body reacts to the new treatment.

You would be given the experimental treatment, and researchers would carefully watch for any side effects. There would also be follow-up appointments after you stop taking the treatment to make sure you remain well. The total length of time someone would be involved in the study is also not yet known.

Potential risks and benefits

As this is a Phase 1 trial, the main potential benefit isn't necessarily directly improving your health condition, but contributing to scientific understanding that might help others in the future. There’s also the possibility of being among the first to receive a new treatment for a condition. However, because it's a very early-stage trial, the risks are generally higher than in later stages. These risks include unknown side effects or the treatment not working as expected. You would always be fully informed of all known risks before joining, 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.

Simbec Research Limited
City only
Mid Glamorgan, United Kingdom

Common questions

What is a 'Phase 1' trial?

It's the very first stage where a new medicine or treatment is tested in people. The main aim is to check if it's safe and to find the right dose, not to see if it cures a disease.

Why aren't all the details available yet?

It's common for very early-stage trials to keep details private until later. This allows researchers to complete their work. The full information will be shared within about two and a half years after the trial finishes.

Who can take part in this study?

We know that participants must be between 18 and 65 years old, of any gender. Other specific health requirements are not yet public.

Will this treatment cure my condition?

In a Phase 1 trial, finding a cure isn't the primary goal. The focus is on safety and dosage. Any effects on a condition would be discovered in later trial stages.

What is SYX-5219-101?

This is the code name for the new treatment being tested in this study.

How to find out more

Gordon Dingwall

gordon.dingwall@sitryx.com +44 (0)1865 648401 Official trial record

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