RecruitingPhase IInterventional

Phase I Trial: 36540 (DF-PK-01)

This trial is a 'Phase I' study, which means it's one of the first times a new treatment is being tested in people. The main goal of a Phase I study is usually to check if a new treatment is safe and to find the right dose. The rules around privacy mean that the complete information about this study, including what condition it's for, what treatments are being given, and who can or cannot join, isn't fully available right now. However, these details will be made public within 30 months after the study has officially ended. The study is open to both men and women between the ages of 20 and 65 years.

At a glance

Status

Recruiting

Phase

Phase I

Sponsor

DF Medical Ventures Limited

Enrolment target

Start

09 Jan 2026

Estimated completion

05 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 I' clinical trial, which means it's an important early step in testing a new treatment. When scientists develop a new medicine or therapy, they need to follow a series of careful steps to make sure it's safe and effective.

In a Phase I trial, the main goal is often to see if the new treatment is safe for people and to figure out what dose might be best. It's not usually about whether the treatment can cure a certain illness, but more about understanding how the body reacts to it. Because this is such an early stage, full details about the specific condition being studied, the exact treatments involved, and detailed criteria for joining are not immediately available to the public.

The organisation that oversees health research in the UK, called the Health Research Authority (HRA), has approved that these full details can be shared a bit later. This is quite common, especially in early trials, to protect the privacy of the research and the people involved. Don't worry though, all the important information will be made public within 30 months after the study has finished.

Key takeaways

This is an early-stage 'Phase I' clinical trial.
The full study details will be released within 30 months after the trial ends.
Participants must be between 20 and 65 years old.
Both men and women can potentially join.
The main aim of a Phase I trial is to check safety and find the right dose.

Who may be eligible?

While the complete details of who can join are not yet public, we do know that this study is looking for volunteers who are between 20 and 65 years old. Both men and women are welcome to take part in this research.

Because this is an early-stage study, there will be very specific health requirements that you need to meet. For example, researchers will need to make sure you don't have any other health conditions or take certain medications that could affect how the new treatment works or how safely it can be given to you.

The full list of things that would make someone suitable (inclusion) or unsuitable (exclusion) for this study isn't available yet. Once the study has ended, or within 30 months of its completion, these important details will be shared, giving a clearer picture of the participants involved.

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.

Are you between 20 and 65 years old?
Are you male or female?
Are you able to commit to several study appointments?
Are you comfortable with receiving an experimental treatment?
Are you willing to have regular health checks and tests?

Answer every question to see your result.

What does participation involve?

Since the full details of this study are not yet public, we can only give you general information about what taking part in a Phase I trial typically involves. You would likely need to attend several appointments at a research clinic or hospital. These visits usually involve health checks, blood tests, and possibly other tests like heart scans.

You would be given the new treatment, which could be a tablet, injection, or infusion. Researchers would monitor you closely to see how your body reacts to the treatment. This might mean staying at the clinic for a short period after each dose, or possibly overnight.

There would also be follow-up appointments after you finish taking the treatment to ensure your health remains stable. The total duration of your participation could vary, perhaps from a few weeks to several months, depending on the study's specific design.

Potential risks and benefits

Participating in any clinical trial, especially a Phase I study, involves potential benefits and risks. A potential benefit is contributing to medical science and helping to develop new treatments that could help others in the future. You would also receive careful health monitoring during the study. However, because this is an early treatment being tested, there's always a risk that you might experience side effects, some of which could be new or unexpected. Researchers will explain all known risks to you before you agree to join. Remember, you would always 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-Orion Clinical Pharmacology (AKA Simbec Research Ltd)
City only
Merthyr Tydfil, Wales

Common questions

What is a 'Phase I' trial?

A Phase I trial is one of the first steps in testing a new treatment in humans. It mostly focuses on finding out if the treatment is safe and what the right dose might be.

Why aren't all the details available now?

The Health Research Authority has approved a delay in sharing the full details. This is sometimes done in early studies to protect the research and participant privacy, but all information will be public later.

Who can take part in this study?

The study is looking for men and women aged between 20 and 65 years old. More specific health requirements will be available when full details are released.

When will I be able to see the full study information?

The complete details of the trial will be added to the study record within 30 months after the trial has officially finished.

Will I get paid to take part?

While not directly mentioned, some clinical trials offer reimbursement for travel costs and time. This would be clearly explained if you were invited to participate.

How to find out more

Julian Fox

jpf@dfmvi.com N/A Official trial record

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