CompletedPhase IInterventional

Phase I Trial: 36676 (P2-101-301P)

This is a very early study, called a Phase I trial, for a new treatment. At the moment, we can't share all the specific details about what conditions it's for or what the treatment involves. This is because the UK's Health Research Authority has agreed to delay publishing the full information until 30 months after the study has finished. This sometimes happens to protect ongoing research. We do know that the study is open to both men and women aged between 18 and 55 years old. More information will become available in the future.

At a glance

Status

Completed

Phase

Phase I

Sponsor

Phase Pharmaceuticals LLC

Enrolment target

Start

05 Aug 2025

Estimated completion

20 Oct 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, known as a Phase I trial, is the very first step in testing a new treatment in people. Phase I trials are mainly designed to check if a new treatment is safe and to find the right dose. They usually involve a small number of healthy volunteers or people with a specific condition.

At this time, we don't have all the details about what specific health conditions this treatment is targeting, or exactly what the treatment itself involves. This is because the Health Research Authority (HRA), an organisation that oversees health research in the UK, has approved a delay in making this information public. They often do this to protect the integrity of the research while it's ongoing.

All the detailed information will be made public and added to the study's official record within 30 months after the entire trial has been completed. Until then, we only know that it's an early safety study for adults aged 18 to 55.

Key takeaways

This is a very early, (Phase I) study for a new treatment.
Full details about the study are not yet publicly available.
The information will be released within 30 months after the study finishes.
It is for adults strictly aged 18 to 55 years old, both men and women.
Phase I studies primarily focus on finding a safe dose and checking for side effects.

Who may be eligible?

This study is looking for adults who are between 18 and 55 years old. Both men and women can take part.

Unfortunately, because the full details of this study are not yet public, we can't tell you about any specific health conditions that might make you suitable or unsuitable for this trial. Usually, for early-stage studies like this, researchers look for participants who meet very specific health criteria to ensure safety.

Once the full details are released, which will be within 30 months after the study ends, more information will be available about who can and cannot join.

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 18 and 55 years old?
Are you male or female?
Are you able to commit to regular hospital or clinic visits?
Are you willing to potentially receive a new, untested treatment?

Answer every question to see your result.

What does participation involve?

Because the full details of this study are being kept private for now, we can't give you specific information on what taking part would involve. In general, for a Phase I study, participants usually:

* Have several visits to a clinic for health checks. * May receive the new treatment, possibly as pills, injections, or infusions. * Have tests like blood samples, urine tests, and sometimes scans to monitor their health and how their body reacts to the treatment. * Attend follow-up visits after the treatment finishes to make sure they are well.

The total amount of time you would need to commit and how often visits are required will depend on the specific study plan, which is currently not public.

Potential risks and benefits

Since this is a very early-stage trial and specific details are currently unavailable, we can't outline the exact potential benefits or risks. Generally, participants in Phase I trials may not directly benefit from the treatment, as the main goal is to test safety. However, they contribute valuable information that could help others in the future. There are always potential risks with any new medication, including side effects, which would be explained in detail if you were to consider joining. You always have the right to withdraw from a 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 Research Limited
City only
Mid Glamorgan, United Kingdom

Common questions

What is a Phase I trial?

A Phase I trial is the very first step in testing a new treatment in people. It mainly checks if the treatment is safe and helps find the right dose.

Why can't I see all the details now?

The UK's Health Research Authority has agreed to delay publishing the full details for a period to protect the ongoing research. This sometimes happens with early-stage studies.

When will more information be available?

All the specific details about the study will be made public within 30 months after the entire trial has completed.

Who can take part in this study?

This study is open to men and women aged between 18 and 55 years old.

Will I get the new treatment if I join?

In a Phase I study, you would likely receive the new treatment, but the main goal is to test its safety rather than provide direct health benefits.

How to find out more

Lynn Howard

lynn@phasepharma.com +1 (0)917 683 1240 Official trial record

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