CompletedPhase IInterventional

Phase I trial HMR code: 25-004

This is an early research study, often called a Phase I trial, involving healthy women. The main goal of such trials is to find out if a new medicine or treatment is safe for people. Because it's very early research, not all the details are available to the public yet. This is expected to change and more information about the study, including what exactly is being tested, will be published within 30 months (about two and a half years) after the study officially ends. For now, we know they are looking for healthy women to take part, and the full scientific name of the trial will also be released later.

At a glance

Status

Completed

Phase

Phase I

Sponsor

Besins Healthcare Ireland Ltd

Enrolment target

Start

03 Sep 2025

Estimated completion

30 Apr 2026

Healthy volunteers

What is this study about?

This study is an early-stage medical research project. These types of studies, called 'Phase I trials,' are a vital step in developing new treatments. Their main purpose is to check if a new medicine or treatment is safe in humans for the very first time. They also help researchers understand how the body handles the new treatment, such as how it's absorbed and processed.

At this point, many of the specific details about what exactly is being tested in this trial are not yet available to the public. This is sometimes normal for very early research, as companies might want to protect their new discoveries for a time. The good news is that the information will be shared. The researchers have committed to making all the full details of this study available within 30 months (about two and a half years) after the study has officially completed.

The fact that they are looking for 'healthy volunteers' means that the participants in this study are generally well with no significant medical conditions. This helps researchers focus purely on how the new treatment affects the body, without other health problems complicating the results. It's an important first step before a treatment can be tested in people who actually have the condition it aims to treat.

Key takeaways

This is an early-stage study (Phase I) of a new treatment.
It's looking for healthy female volunteers.
The main aim is to check the treatment's safety in people.
Full details about the treatment will be released later (within 30 months after the study ends).
Your safety will be closely monitored if you take part.
You can always choose to leave the study at any time.

Who may be eligible?

To join this study, you must be a healthy woman. This means you should generally be in good health and not have any serious medical conditions that could affect the study results.

Because this is an early-stage trial where details are still being kept private by the sponsor, we don't have all the specific reasons why someone might *not* be able to join (these are called 'exclusion criteria'). However, typically in studies like this, you might not be able to take part if you are pregnant, breastfeeding, or if you have certain existing health issues, are taking specific medications, or have participated in other clinical trials recently.

Once the full details are released after the trial ends, more specific information about who could and couldn't join will be available. For now, the most important thing is that you identify as a healthy woman.

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 a woman?
Do you generally consider yourself to be in good health?
Are you able to attend appointments at the study clinic?
Are you comfortable with the idea of taking a new, untested treatment?

Answer every question to see your result.

What does participation involve?

Since the full details of this study are being kept private for now, we don't have all the specifics on what taking part would involve. However, in a typical early-stage (Phase I) study for healthy volunteers, you would likely have няколко visits to the study clinic. These visits could involve:

* **Screening tests:** To confirm you're healthy and meet other general study requirements. This might include blood tests, a physical exam, and an in-depth chat about your medical history. * **Taking the study treatment:** This could be a pill, an injection, or another form of medicine. Researchers would carefully monitor you after you receive it. * **Assessments:** Regular checks like blood pressure, heart rate, temperature, blood samples, and urine samples to see how your body is responding to the treatment and to check for any side effects. * **Follow-up visits:** Even after you've stopped taking the treatment, you might have further visits or calls to make sure you're doing well and to check for any long-term effects.

The total duration of your involvement could range from a few days to several weeks, depending on the specific schedule of the treatment and follow-up. All these steps are designed to ensure your safety and gather accurate information about the new treatment.

Potential risks and benefits

Taking part in any medical study carries potential risks and potential benefits. For this study, the main 'benefit' isn't a direct treatment for an illness, but rather the knowledge gained that could help develop new medicines for others in the future. You might also receive expert medical care and monitoring during the study period. Potential risks are carefully considered in all clinical trials. Because this is a very early study and specific details are limited, we can't list exact risks, but typically they could include side effects from the investigational treatment, discomfort from procedures like blood draws, or even that the treatment might not be effective or could cause unexpected reactions. Your safety is paramount, and you would be closely monitored. Remember, you would always have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (1)

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

Hammersmith Medicines Research (HMR)
City only
London, England

Common questions

What is a 'Phase I trial'?

It's the very first stage of testing a new treatment in humans, mainly to check if it's safe for people. It also helps researchers understand how the body handles the treatment.

Why are only women being asked to join?

This study specifically requires female participants, likely because the new treatment may work differently in women or is designed for a condition that affects women.

Why can't I see all the details about the treatment now?

Sometimes, for very early research, companies keep details private for a while to protect their new discoveries. All information will be publicly shared within 30 months after the study ends.

What does 'healthy volunteer' mean?

It means participants should be generally well, without major health problems, so researchers can focus on how the new treatment affects the body itself.

Will I get paid for taking part?

The information provided doesn't say if participants will be paid. In many healthy volunteer studies, expenses for travel and time may be covered, but this would need to be confirmed by the study team.

How to find out more

Clinical Operations Department

clinicaloperations@besins-healthcare.com +353 871039215 Official trial record

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