Deferred registration: Fortrea code: 780587
This is a Phase 1 clinical trial run by the medical research company Fortrea. Phase 1 studies are the earliest stage of testing a treatment in people, focusing closely on safety, dosage, and how the body processes the medicine. At present, full details about the specific health condition, the medicine, and the exact procedures are not publicly displayed. The UK Health Research Authority (HRA), which oversees research safety and ethics in the UK, has granted a temporary delay (deferral) on publishing this information. This is common practice to protect sensitive scientific data while plans are finalised. What is known is that the trial is open to both men and women aged 35 to 55. Once the approved deferral date arrives, full details will be published on the trial register.
At a glance
What is this study about?
Every new medicine must go through carefully monitored stages called clinical trials before it can be prescribed widely. This study, known by the reference code Fortrea 780587, is a Phase 1 clinical trial. Phase 1 is the first time a new medicine is given to humans. The main goal is not yet to prove how well it cures an illness, but to make sure it is safe, to find the right dose, and to see how the human body breaks it down.
You might notice that detailed information about what this trial is treating or testing is missing from the public record. In the UK, the Health Research Authority (HRA) can grant permission to delay—or 'defer'—the release of study details. This deferral is often requested for commercial reasons or to protect new scientific discoveries before they are officially launched.
Even though the public information is temporarily delayed, the trial must still meet all strict UK legal, safety, and ethical standards before any volunteer can take part. Full details about the study goals, treatments, and procedures will be updated on the public trial registry on or before the agreed deferral deadline.
Key takeaways
- This is an early Phase 1 safety trial with the code Fortrea 780587.
- The trial is open to adults between 35 and 55 years of age.
- Detailed information about the medicine and condition is temporarily delayed with official approval.
- The study must still follow strict UK safety and ethical rules before volunteers take part.
- Taking part is voluntary, and you can leave at any time without affecting your NHS care.
Who may be eligible?
Because the full study details are deferred, the complete list of criteria for joining has not yet been published. However, the trial record specifies that it is open to adults between the ages of 35 and 55, including all sexes.
Phase 1 trials typically recruit either healthy volunteers or people with a very specific, diagnosed condition. Usually, participants must undergo a thorough medical check-up to ensure their heart, liver, and kidneys are functioning well.
Once the full study criteria are published, detailed rules on previous illnesses, everyday medications, and lifestyle restrictions (such as smoking or alcohol use) will be clearly listed.
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 between 35 and 55 years old.
- I am open to learning more about early-stage (Phase 1) clinical trials.
- I can attend visits at a clinical research centre if needed.
- I understand that full medical criteria will be shared once the official delay period ends.
What does participation involve?
Taking part in a Phase 1 study usually takes place at a specialised clinical research facility. Before joining, you will have a screening visit where doctors check your medical history, take blood samples, and carry out routine tests like heart traces (ECGs) to make sure it is safe for you to take part. Depending on the study design, you may receive the study medicine as a tablet, an injection, or an infusion. Some Phase 1 studies require overnight stays in a clinic so the team can monitor you around the clock, while others only involve daytime appointments. You will also have follow-up visits to check on your recovery and well-being. The exact schedule, number of visits, and total time commitment will be fully explained in an information leaflet before you decide to join.
Potential risks and benefits
Locations (1)
- Fortrea Clinical Research UnitCity onlyLeeds, England
Common questions
Why are the study details deferred?
The UK Health Research Authority allows study organisers to delay publishing full details for a limited time, usually to protect confidential scientific research or commercial patents.
What happens during a Phase 1 trial?
Phase 1 trials are early research studies. Doctors give small doses of a new treatment to closely monitor safety, side effects, and how the body handles the medicine.
Can I leave the study if I change my mind?
Yes. Taking part in research is always voluntary. You are free to withdraw at any point without giving a reason and without losing any normal NHS care.
Who is Fortrea?
Fortrea is a clinical research organisation that manages and carries out clinical trials on behalf of universities, doctors, and pharmaceutical companies.
When will more information be available?
Complete details about the study will be uploaded to the official public register on or before the deferral expiry date set by the Health Research Authority.
How to find out more
Jonathan Ackroyd
Always speak to your GP or specialist before deciding to take part in a study.
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