RecruitingPhase IInterventional

Deferred registration: Fortrea code: 776181

This is a Phase 1 clinical trial organised by a research organisation called Fortrea. Phase 1 trials are usually the first step in testing a new medicine in people to check that it is safe and to understand how the body handles it. At present, this trial has 'deferred registration'. This is an official arrangement that allows researchers to delay publishing the full details of the study, such as the exact medicine being tested, to protect sensitive research information. The trial record lists healthy volunteers aged from birth up to one year old. However, the complete list of who can and cannot join, as well as the exact tests involved, will only be made public once the deferral period expires. No medical recommendations are made, and anyone interested will need to wait for further public updates.

At a glance

Status

Recruiting

Phase

Phase I

Sponsor

Lundbeck (Denmark)

Enrolment target

Start

15 Jul 2026

Estimated completion

03 Nov 2026

This is a phase I trial in healthy volunteers only and qualifies for an automatic deferral. The full details will be added to the trial record on or before the deferral expiry date

What is this study about?

This study is a Phase 1 clinical trial. When scientists develop a new treatment, Phase 1 is typically the very first time it is given to human beings. The main goal at this stage is not to cure an illness, but to check safety, monitor for side effects, and see how the body absorbs and clears the medicine. These studies are almost always carried out under very close medical supervision in specialised clinics.

You may notice that many details about this trial are not yet visible. This is because the trial has been granted a 'deferred registration'. In medical research, companies and scientists are sometimes allowed to delay releasing full scientific details to the public for a set period. This helps protect new scientific inventions and patents before they are widely shared. Full details must be added to the registry on or before a set deadline.

Even though the details are currently hidden, all clinical trials in the UK must still be reviewed and approved by independent research ethics committees and regulatory authorities. These bodies ensure that any planned trial meets strict legal safety standards before any volunteer can be enrolled.

Key takeaways

This is an early-stage Phase 1 trial for healthy volunteers.
Full details about the medicine and tests are currently kept private under an official deferral.
The registry currently lists the age range as birth up to one year old.
Phase 1 trials focus purely on safety and how the body handles a medicine, offering no direct health benefits.
Complete trial details will be added to the public record once the deferral period expires.

Who may be eligible?

The public registry currently provides very limited information about who can take part. It states that the study is looking for healthy volunteers, meaning people who do not have serious ongoing medical conditions.

The age range given in the study record is from birth up to one year old (0 to 1 year), and it is open to all sexes. However, because this is an early-stage study with deferred details, specific health criteria have not yet been published.

The exact rules about who can join (inclusion criteria) and who cannot join (exclusion criteria) will be added to the public record as soon as the deferral period ends. Parents or guardians should check back for updates once the full details are released.

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.

The participant is between 0 and 1 year old.
The participant is considered in good general health.
A parent or legal guardian is available to give informed consent.
You are willing to wait until the full eligibility criteria are published.

Answer every question to see your result.

What does participation involve?

Because the trial details are currently deferred, the exact schedule of visits and procedures has not been published. However, taking part in a Phase 1 healthy volunteer study typically involves an initial screening visit to check general health. This often includes physical examinations, blood tests, and heart checks. If accepted, participants receive the study medicine under careful observation by doctors and nurses. There is usually a monitoring period that may involve staying at a research clinic, followed by check-up visits to ensure there are no lasting side effects. The exact length of time, number of visits, and medicines used will be confirmed once the study details are updated.

Potential risks and benefits

Phase 1 trials in healthy volunteers do not provide any direct medical benefits, as the participants do not have the condition the drug is designed to treat. The purpose is purely to help scientific understanding. Every new medicine carries risks, including unexpected side effects, allergic reactions, or discomfort from medical tests like blood draws. Safety is closely tracked, and taking part is completely voluntary. Parents or guardians can choose to withdraw their child from the study at any time without giving a reason and without it affecting their normal NHS care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Fortrea Clinical Research Unit
City only
Leeds, England

Common questions

What does 'deferred registration' mean?

It means the researchers have registered the trial with authorities, but have been granted temporary permission to keep the full scientific details private to protect new research data.

What is the purpose of a Phase 1 trial?

Phase 1 trials are early studies designed to test the safety of a new medicine, see how the human body processes it, and find the right dose.

Will taking part cure an illness?

No. Because this trial is for healthy volunteers, there is no expected direct health benefit to the person taking part.

Are healthy volunteer studies safe?

All clinical trials carry some risk of side effects. However, they are strictly reviewed by independent ethics panels and volunteers are monitored very closely by medical staff.

When will more information be available?

The full details, including the treatment name and how to take part, must be published on the registry on or before the deferral expiry date.

How to find out more

Firas Almazedi

firas.almazedi@fortrea.com 441133013642 Official trial record

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