CompletedPhase IInterventional

Phase I Trial: 36414 (SUDO-550-102)

This is an early-stage study, often called a 'Phase I' trial. It's looking for healthy female volunteers, aged between 18 and 55, to help test a new medicine or treatment. The main goal of a study like this is to understand if the new treatment is safe and how the body reacts to it, rather than to treat a specific illness. For now, the full details of what the treatment is or what exactly participants will do are not public. This is sometimes agreed with health authorities, and the information will be released later, within 30 months after the study has finished. Participation is completely voluntary and essential for the development of future healthcare options.

At a glance

Status

Completed

Phase

Phase I

Sponsor

Sudo Biosciences Ltd

Enrolment target

Start

08 Dec 2025

Estimated completion

08 Feb 2026

N/A - healthy volunteers

What is this study about?

This study, known as 36414 (SUDO-550-102), is a 'Phase I' trial. This is the very first stage of testing a new medicine or treatment in people. The main purpose of these early studies is to check for safety and to see how the body handles the new medicine – for example, how much to give and how often. It's not about treating a specific illness, but rather understanding if the treatment is safe enough to be tested in larger groups of people later on.

For this particular study, they are looking for healthy volunteers, specifically women between the ages of 18 and 55. This helps researchers understand how the new treatment affects healthy individuals before it's given to people who are unwell. These healthy volunteer studies are a really important step in the long process of developing new medicines and making sure they are safe and effective for everyone.

At the moment, the full details about the specific treatment being tested and what exactly participants will be asked to do are not currently available to the public. This has been agreed with the Health Research Authority (HRA), which is an organisation that makes sure research is ethical and safe. The complete information will be made public within 30 months after the study has finished.

Key takeaways

This is an early-stage (Phase I) study.
It's recruiting healthy women aged 18 to 55.
The main goal is to test the safety of a new medicine or treatment.
Full study details are currently not public but will be released later.
No direct health benefits are expected for participants.

Who may be eligible?

To join this study, you need to be a healthy woman between 18 and 55 years old. This means that if you have any ongoing health problems, you might not be able to take part. Researchers usually look for people who are in good general health for these early-stage studies.

Because the full details of the study haven't been released yet, we don't have all the specific rules about who can and cannot join. There will be other things that make someone suitable or unsuitable for the study, which will be explained in full when the information becomes public.

Once the full details are available, there will be clear lists of things that would allow you to join (inclusion criteria) and things that would prevent you from joining (exclusion criteria). These are very important to make sure the study is safe for everyone involved and that the results are clear.

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?
Are you between 18 and 55 years old?
Do you consider yourself generally healthy?
Are you interested in understanding more about new treatments?

Answer every question to see your result.

What does participation involve?

Because the full details of this study are not yet public, we can't tell you exactly what taking part would involve. However, typically in a Phase I study for healthy volunteers, you might be asked to:

* Attend several appointments at a clinic or research centre. * Have various health checks, such as blood tests, urine tests, and heart readings (like an ECG). * Be given the new medicine or treatment, often starting with a very small dose. * Stay at the research clinic for a period, sometimes overnight or for several days, for close monitoring after receiving the treatment. * Have follow-up appointments after you've left the clinic to see how your body is doing. The total duration of participation usually varies from a few weeks to a few months, depending on the specific study design.

Potential risks and benefits

Since the full details of this study are not public yet, we cannot give specific information about potential benefits or risks. Generally, for healthy volunteers in a Phase I study, there is no direct health benefit from the treatment itself, as the study is focused on safety. However, volunteers often receive comprehensive health check-ups and may be compensated for their time and travel. Potential risks could include side effects from the new treatment, which might be mild, moderate, or, in rare cases, more serious. All such risks would be fully explained before you agree to take part. It's very important to remember that you would 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.

Simbec-Orion Clinical Pharmacology (AKA Simbec Research Ltd)
City only
Merthyr Tydfil, Wales

Common questions

What kind of healthy volunteers are needed?

This study is specifically looking for healthy women between the ages of 18 and 55.

What is a 'Phase I' trial?

A Phase I trial is the earliest stage of human testing for a new medicine or treatment, mainly to check if it's safe and how the body handles it.

Why aren't the full study details public yet?

The Health Research Authority (HRA) has approved a delay in releasing the full details. This sometimes happens, and the information will be shared once the study has ended, within 30 months.

Will I get paid for taking part?

While specific details are not published, healthy volunteers in Phase I studies are often compensated for their time, travel, and any inconvenience related to participation.

When will more information about the study be available?

The full details of the study will be added to the public record within 30 months after the study has officially finished.

How to find out more

Ian Mills

IMills@sudobio.com N/A Official trial record

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