RecruitingPhase IInterventional

Phase I trial: QSC303485

This is an early-stage research study, known as Phase I, called QSC303485. In this kind of study, researchers are usually testing a new treatment or medication for the first time in people to see if it's safe and how it works in the body. At this moment, the full details about what the study is testing and how it will be run are not publicly available. This is a common practice for some new studies, and the information will be published within 30 months of the study ending. We do know that the study is open to adult volunteers aged 18 to 65, including both men and women.

At a glance

Status

Recruiting

Phase

Phase I

Sponsor

Congruence Therapeutics Inc.

Enrolment target

124

Start

24 Feb 2026

Estimated completion

10 May 2027

The sponsor has confirmed that the trial meets the criteria for 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?

You've come across information about a research study called QSC303485. This is what's known as a 'Phase I' trial. Think of medical research like a journey; Phase I is usually the very first step where a new medicine or treatment is tested in people.

The main goal of a Phase I study is often to see if a new treatment is safe and to figure out the right dose. Researchers are carefully looking at how the new treatment affects the body and if there are any side effects. It's about gathering initial information to decide if it's safe enough to move to the next stage of testing.

At the moment, the full details about exactly what this study is investigating and how it will be carried out aren't public. This isn't unusual for very early-stage trials. The organisation running the study has decided to share these details later, specifically within 30 months after the study has officially finished. This means that while we know a study is happening, the specific aims and methods will be clearer in the future.

Key takeaways

QSC303485 is a very early (Phase I) research study.
It's looking at a new treatment or medication for the first time in people.
The main goals are usually to check safety and find a suitable dose.
Full details about the study won't be public until 30 months after it ends.
The study is open to adult volunteers aged 18 to 65, both men and women.

Who may be eligible?

Currently, we have limited information about who can and cannot join this study. This is because the full details are being kept private for a set period, which is a fairly common practice in early research.

What we do know is that this study is looking for adult volunteers. To be considered, you must be between 18 and 65 years old. The study is open to both men and women.

Once the full details are released, which will be within 30 months after the study has ended, there will be much more specific information about other health conditions, medications, or lifestyle factors that might affect whether someone can take part.

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 65 years old?
Are you a man or a woman?
Are you willing for full study details to be shared later?
Are you able to commit to potential regular visits and tests?

Answer every question to see your result.

What does participation involve?

As the full details of this particular study are not yet publicly available, we can't give you a precise breakdown of what taking part would involve. However, typically in a Phase I study, especially one that hasn't shared its full plan, participation might include:

* **Initial health checks:** You would likely have a thorough medical check-up to make sure you're suitable for the study. * **Taking the study treatment:** You would receive the new treatment at specific times, which could be pills, injections, or another method. * **Regular visits:** You would need to attend appointments at a clinic or hospital for check-ups, blood tests, and to make sure the treatment is safe and working as expected. * **Monitoring and tests:** There would be various tests (like blood tests, urine tests, or scans) to see how your body is reacting to the treatment. * **Follow-up:** Even after you stop taking the treatment, you might have follow-up visits to ensure your health remains good.

The total duration of participating in such a study can vary greatly, from a few weeks to several months, depending on the treatment and what the researchers need to observe. Once the full study details are released, much more specific information about the time commitment will be available.

Potential risks and benefits

Any new treatment comes with potential benefits and potential risks, and this is especially true for early-stage studies like this one. A potential benefit could be helping researchers understand a new treatment, which might help future patients, or in some cases, you might personally benefit if the treatment proves effective for your condition. However, because it's a very early study, the main goal is usually to understand safety, and there's no guarantee of personal benefit. Potential risks include unknown side effects or that the treatment might not work as hoped. You would be carefully monitored throughout the study. It's very important to remember that you would always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

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

Quotient Sciences Limited
City only
Nottingham, England
Addenbrooke’s Hospital, Cambridge University Hospitals NHS Foundation Trust
City only
Cambridge, England

Common questions

What is a Phase I trial?

A Phase I trial is the earliest stage of human testing for a new treatment. Researchers mostly focus on checking if the treatment is safe and finding the right dose.

Why aren't all the study details public yet?

Sometimes, for new or early-stage studies, the organisations running them keep the full plans private for a while. This is a common practice, and the details will be released within 30 months after the study finishes.

Who can take part in this study?

This study is open to adults aged between 18 and 65 years old, including both men and women. More specific health requirements will be known later.

Will I know if the treatment is helping me?

In early-stage studies like this, the main aim is safety and understanding the new treatment, not necessarily finding out if it's effective for a a specific condition right away. Personal benefits are not guaranteed.

Can I leave the study if I change my mind?

Yes, absolutely. You can choose to leave the study at any point, for any reason, without it affecting your routine medical care.

How to find out more

Michael Harvey

clinicaltrials@congruencetx.com +1 (0)4388173666 Official trial record

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