CompletedInterventional

Phase 1 trial: Fortrea CRU code: 8526072

This is an early-stage study, often called a 'Phase 1' trial, designed to test a new treatment. The main goal of this type of study is to see if the treatment is safe for people to use, rather than checking how well it works right away. For this particular study, we're looking for healthy men to take part. All the detailed information about the study, including what exactly is being tested and how it's given, isn't available to the public just yet. However, it will be shared within 30 months after the study has finished. Your participation helps researchers learn vital information about new medicines.

At a glance

Status

Completed

Sponsor

CellCentric Limited

Enrolment target

Start

29 Jan 2025

Estimated completion

04 Feb 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?

This study is an early step in finding new ways to treat health problems, often called a 'Phase 1' trial. Think of it like a very first test drive for a new car – the main aim isn't to see how fast it goes, but to make sure it's safe to be on the road.

In this type of study, researchers are usually testing a new medicine or treatment for the first time in people. They want to check if it's safe, how it behaves in the body, and what the right dose might be. It’s a really important stage because it helps decide whether the new treatment can be studied more widely in the future.

For this specific study, the full details about what exactly is being tested and how it will be done are not yet public. This can sometimes happen with early research. However, a health authority called the HRA (Health Research Authority) has approved this, and all the information will be shared for everyone to see within 30 months after the study has finished. This means that while we can't tell you every detail right now, you can be assured that the study has been carefully reviewed.

Key takeaways

This is an early-stage study to check the safety of a new treatment.
Only healthy adult men are invited to take part.
Full study details will be released in the future.
Taking part helps medical research, but personal benefits aren't guaranteed.
Your safety will be closely monitored throughout the study.
You can withdraw from the study at any time without penalty.

Who may be eligible?

To join this study, the main thing is that you need to be a healthy grown-up man. The researchers are looking for people who are generally well, without any long-term health conditions or illnesses that might affect the study results.

There are no specific age limits mentioned, meaning that men of various adult ages could be considered. However, the study is only open to men, not women.

If you have any health problems, or if you are not a man, then unfortunately this study would not be suitable for you.

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 an adult?
Are you a man?
Are you generally healthy, without any ongoing medical conditions?
Do you understand that this is an early-stage study focused on safety?

Answer every question to see your result.

What does participation involve?

The public details about what taking part in this study would involve are not fully available yet. As this is a 'Phase 1' study, it typically means participants would be closely monitored. This often involves several visits to a clinic, and you might stay there for some time, possibly overnight or for a few days, especially when you first receive the treatment.

During your time in the study, you would likely have regular health checks, blood tests, and other measurements to see how your body is reacting to the treatment. You would be given the new treatment, and medical staff would keep a very close eye on you to make sure you are safe. There might also be follow-up appointments after you've finished taking the treatment. The total duration of participation and the exact number of visits are not specified, but these details would be fully explained if you were invited to consider joining.

Potential risks and benefits

Because this is an early-stage study, the main potential benefit is helping to advance medical knowledge and potentially contributing to new treatments for future patients. For participants, there might not be a direct personal health benefit, as the focus is on safety. There are always potential risks with new treatments, such as unexpected side effects or reactions, some of which could be serious. All these potential risks would be fully explained to you before you agree to take part. 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.

Fortrea Clinical Research Unit Limited
City only
Leeds, United Kingdom

Common questions

What does 'Phase 1 trial' mean?

It's the very first stage of testing a new treatment in people. The main goal is to check if it's safe and how the body handles it.

Why aren't all the study details available?

Sometimes, for early research, the full details aren't made public straight away. However, they will be shared within 30 months after the study ends.

Who can take part in this study?

This study is specifically looking for healthy, adult men. If you have any health conditions, it's likely not suitable for you.

Will I get better if I join this study?

The main goal of this early study is to check safety, not to cure or treat an illness. While you'll be part of important research, a direct health benefit for you personally isn't guaranteed.

Can I stop participating if I change my mind?

Yes, absolutely. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

How to find out more

. Project Management Department

clinical@cellcentric.com +44 1799 531130 Official trial record

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