CompletedPhase IInterventional

Pilot phase I, safety and pharmacokinetic study in healthy participants

This is a very early study, called a Phase I trial, where researchers are giving a new treatment or medicine to healthy volunteers. The main goal is to see if it's safe and to understand how the body deals with it, such as how much of it gets into the blood and how long it stays there. This helps doctors work out the right dose for future studies. For now, specific details about the treatment and study design aren't publicly available, but they will be shared once the trial has finished. This approach ensures patient safety and follows ethical guidelines set by the Health Research Authority.

At a glance

Status

Completed

Phase

Phase I

Sponsor

Mexichem UK Ltd

Enrolment target

Start

01 Oct 2025

Estimated completion

05 Nov 2025

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?

Imagine scientists have developed a brand-new medicine or treatment, but they don't know yet how it will affect people. Before it can be used to help patients with illnesses, they need to make sure it's safe. That's where an early-stage study like this one comes in.

This particular study is a 'Phase I' trial. In this phase, researchers give the new medicine or treatment to a small group of healthy volunteers. The main aim isn't to treat a disease, but to carefully check for any side effects and to see how the body processes the new medicine. This includes understanding how it's absorbed, where it goes in the body, and how quickly it's removed. All these details help doctors find the safest and most effective dose for future research.

For now, the full details about what exactly is being tested and how the study is run aren't being shared publicly right away. This is a common and approved practice, and all the information will be made available within two and a half years after the study has finished. This ensures the research is conducted responsibly and ethically.

Key takeaways

This is an early-stage study (Phase I) checking the safety of a new medicine.
Healthy volunteers are needed to take part.
Full study details will be released after the study has ended, within 30 months.
Your safety will be closely monitored by medical professionals.
You can withdraw from the study at any time without penalty.
Participation helps future medical breakthroughs though offers no direct health benefit to you.

Who may be eligible?

To join this study, you would need to be a healthy volunteer. This means you generally don't have any major ongoing health conditions and aren't taking regular medication that might interfere with the study's medicine.

The researchers are looking for both men and women to take part, and there aren't specific age limits mentioned, meaning a wide range of adults could potentially be considered. However, the exact rules about who can and cannot join are not openly available yet.

When the full study details are released, they will explain very clearly any specific health conditions, past medical treatments, or lifestyle factors that would prevent someone from joining. This is to ensure the safety of everyone 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.

I am generally healthy with no serious ongoing medical conditions.
I am not currently taking any regular prescription medications (unless approved by the study team).
I am willing and able to attend multiple study appointments.
I understand that the exact eligibility rules are not yet public but will be carefully explained.
I am an adult (age range is 'any to any', suggesting most adults could be considered).

Answer every question to see your result.

What does participation involve?

Since this is an early-stage study and the full details are not yet Public, the exact steps for taking part are not known. However, in most early-stage studies like this, participation typically involves several visits to a clinic or hospital. You might have blood tests, urine tests, and other checks to make sure you're healthy at the start, and to monitor how your body reacts to the study medicine. You would be given the study medicine, probably in increasing doses, and doctors would watch you very closely for any effects.

There would be regular follow-up appointments to check on your health and ensure the medicine has left your system. The total length of your involvement, from the first check-up to the final follow-up, can vary greatly but often ranges from a few weeks to a few months, depending on the medicine being tested.

Potential risks and benefits

Participating in any study has potential benefits and risks. For this study, a direct health benefit for you is unlikely, as the medicine is new and its main purpose is to test safety in healthy people. However, you would be helping to advance medical science, which could lead to new treatments for others in the future. Potential risks could include unexpected side effects from the new medicine, which might be mild (like a headache or nausea) or, less commonly, more serious. You would be closely monitored by medical staff for your safety. It's very important to remember that you would 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.

Medicines Evaluation Unit Limited
City only
Manchester, England

Common questions

What does 'Phase I' mean?

Phase I is the very first stage where a new medicine or treatment is tested in people, usually healthy volunteers. The main goal is to check for safety and how the body handles it.

Why aren't all the study details available yet?

Sometimes, for ethical or commercial reasons, a health authority allows study details to be kept private for a set period. All information will be shared once the study has finished, within 30 months.

Will I get paid to take part?

Studies often offer payment or reimbursement for your time, travel, and inconvenience, but this isn't always the case for every study. This specific study's details on payment aren't public yet.

What if I get sick during the study?

You would be carefully watched by doctors and nurses. If you felt unwell, they would check you immediately and provide any necessary medical care. Your safety is the top priority.

Can I leave the study if I change my mind?

Absolutely, yes. You have the full right to withdraw from the study at any point, for any reason, without needing to explain why, and it won't affect any future medical care you receive.

How to find out more

James Murray

james.murray@orbia.com +44 (0)1928518856 Official trial record

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