CompletedPhase IInterventional

Phase 1 Trial: 36342 (DT-101/102)

This is a Phase 1 clinical trial, which means it's one of the first times this new treatment, known as DT-101/102, is being tested in people. The main goal of this early stage is to check if the new treatment is safe and to find out what dose might be best. Researchers will also look for any side effects. Because this is such an early study, not all the details are available yet. The organisation that oversees medical research in the UK, the Health Research Authority (HRA), has allowed the full information about the trial to be published a bit later. This will happen within 30 months after the trial has been completed. This study is open to both men and women between the ages of 18 and 55.

At a glance

Status

Completed

Phase

Phase I

Sponsor

Draig Therapeutics Ltd

Enrolment target

Start

30 Apr 2025

Estimated completion

04 Jun 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 Phase 1 Trial: 36342 (DT-101/102), is a very early step in testing a new treatment. Think of it like a new medicine going through its first safety checks. The main purpose of a Phase 1 trial isn't to see if the treatment works for a specific illness yet, but rather to make sure it's safe for people to take and to understand how our bodies react to it. This involves looking closely at any side effects and figuring out the right amount, or 'dose,' of the treatment that people can safely have.

The Health Research Authority (HRA) is the organisation in the UK that approves and oversees health research. For this particular trial, they have given permission for some of the detailed information to be shared later on. This means that while the study is definitely happening with their approval, the full breakdown of everything involved isn't immediately available to the public. Don't worry, this is sometimes part of the process for brand new treatments.

Once the trial is finished, all the detailed information and findings will be made public. This typically happens within 30 months after the study has officially ended. This ensures that eventually, everyone can see the full picture of what was learned from this very important early research.

Key takeaways

This is a Phase 1 clinical trial, focusing on the safety of a new treatment (DT-101/102).
Full study details will be published within 30 months after the trial ends.
Brave volunteers aged 18-55, of any gender, are needed.
Participation often involves regular clinic visits for monitoring.
The main benefit of joining is helping science, not necessarily a cure for yourself.
You can always leave the study at any time.

Who may be eligible?

To be able to take part in this study, you must be an adult between 18 and 55 years old, inclusive. Both men and women can participate. Beyond these basics, the specific health conditions, lifestyle factors, or past medical history that would allow you to join or prevent you from joining are not yet available for public viewing.

Because this is an early-stage study, the full list of who can or cannot take part is not public yet. However, typically in these types of trials, volunteers need to be in generally good health and not taking many other medications, as researchers want to clearly see the effects of the new treatment.

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 clinic visits (if required)?
Are you generally in good health (as is often required for Phase 1 trials)?

Answer every question to see your result.

What does participation involve?

Since the full details of this trial are not yet publicly available, we can't provide specific information about what taking part would involve. However, typically in a Phase 1 study, participants can expect:

* **Regular Visits:** You would likely need to attend a clinic frequently for health checks, blood tests, and to receive the study treatment. * **Assessments:** These visits would include various health assessments to monitor your body's reaction to the treatment and check for any side effects. * **Medication:** You would be given the new study treatment, DT-101/102, according to a specific schedule. * **Follow-up:** After you finish taking the treatment, there will be follow-up appointments to make sure you remain well. * **Total Duration:** Phase 1 trials can vary, but generally, they might last from a few weeks to several months, including follow-up time.

Potential risks and benefits

Because this is a very early trial, the potential benefits are not yet known, as the main goal is safety, not treating a disease. Volunteers in Phase 1 trials often don't directly benefit, but they play a vital role in helping to develop future medicines. Potential risks always exist with any new treatment; these could include unexpected side effects, which the study team would monitor very closely. You always 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 Research Limited
City only
Mid Glamorgan, United Kingdom

Common questions

What does 'Phase 1' mean?

Phase 1 means it's the very first time a new treatment is being tested in people. The main aim is to check if it's safe and to find the right dose.

Why aren't all the details available yet?

The UK's Health Research Authority (HRA) has allowed the full details to be shared later, within 30 months after the study has ended. This is sometimes part of the process for new treatments.

Who can take part in this study?

This study is open to both men and women who are between 18 and 55 years old. More specific requirements are not yet public.

Will I get better if I join this trial?

In a Phase 1 trial, the main goal is to test safety, not to treat an illness. While your help is crucial for future medicines, you may not directly benefit from the treatment itself.

Can I leave the study if I change my mind?

Yes, absolutely. You can withdraw from the study at any time, for any reason, and it will not affect your usual medical care.

How to find out more

Jennifer Swettenham

jswettenham@draigtherapeutics.com +44 (0)29 2002 8450 Official trial record

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