CompletedPhase IInterventional

Phase I Trial: Quotient Code QSC301642

This clinical trial, known as QSC301642, is an initial study (Phase I) to evaluate a new treatment. Currently, the full details about what the treatment is and why it's being tested are being kept private. This is a common step during the early stages of developing new medicines, allowing researchers to gather information before making it widely available. We do know that the study is looking for men between the ages of 30 and 65 years old. The purpose of Phase I trials like this is often to check if a new medicine is safe and to understand how it behaves in the body, rather than treating a specific illness. More complete information about the trial will be released within 30 months after the study has officially come to an end.

At a glance

Status

Completed

Phase

Phase I

Sponsor

Shionogi B.V.

Enrolment target

Start

05 May 2025

Estimated completion

08 Jun 2025

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?

This study, called QSC301642, is a very early stage (Phase I) clinical trial. Clinical trials are research studies involving people that aim to test new treatments, interventions, or ways of finding diseases. Phase I trials are usually the first step in testing a new medicine in humans. Their main goal is to check for safety, find the best dose, and see how the body handles the new treatment.

At this point, the organisers of the study have decided not to share all the detailed information about what is being tested. This is sometimes done in the early stages of research to protect the information about a new treatment before it's ready for wider discussion. However, they have promised to make all the information public within 30 months after the study is completed. This helps ensure transparency in research.

While we don't have all the specifics yet, participating in a Phase I trial means you would be helping researchers learn more about a new potential medicine. This helps in the long process of developing new treatments that could potentially help many people in the future.

Key takeaways

This is an early-stage (Phase I) study testing a new medicine.
The full details of the study will be released later.
It is for men aged 30 to 65 years old.
The main aim is to check the safety of the new treatment.
Participating helps advance medical research for potential future treatments.

Who may be eligible?

This study is specifically looking for men who are between 30 and 65 years old. If you fit within this age range and are male, you might be someone they are looking for.

Right now, the detailed list of other things that might make someone suitable or unsuitable for the study isn't available. Sometimes these details include things like your overall health, any other medical conditions you have, or medicines you currently take. These factors are important because they help the researchers make sure the study is safe for participants and that the results they get are clear.

Once the full details become available, we will be able to provide a clearer picture of all the reasons someone might be able to join, or why they might not be able to.

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 male?
Are you between 30 and 65 years old?
Are you generally healthy and willing to follow study instructions?
Are you able to attend regular clinic appointments?

Answer every question to see your result.

What does participation involve?

As the full details of this study are not yet available, we can't provide specific information on what taking part would involve. Generally, in a Phase I study like this, participants might have several visits to a clinic or hospital for check-ups, blood tests, and to receive the study treatment. The treatment would likely be the new medicine being tested. You would be closely monitored for any reactions or side effects.

Follow-up appointments would also be common to see how you are doing after taking the treatment. The total length of your participation, including all visits and follow-up, would depend on the study design. Usually, Phase I trials involve a relatively short period of receiving the treatment, followed by a time to monitor its effects.

Potential risks and benefits

Participating in any clinical trial involves potential benefits and risks. The main benefit of this Phase I study is contributing to medical science and helping to understand a new potential treatment. You would be among the first to receive this new medicine. However, because this is a very early study, the direct benefit to your health is not the primary goal, and there might be unexpected side effects, or the treatment might not work as hoped. While researchers take great care to ensure safety, there's always a chance of side effects, ranging from mild to serious. You would 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.

Quotient Sciences Limited
City only
Nottingham, United Kingdom

Common questions

What is a Phase I trial?

It's the very first stage of testing a new medicine in people. It mainly checks if the new medicine is safe and how the body handles it, rather than treating a specific illness.

Why aren't all the study details available now?

Sometimes, in the early stages of developing new medicines, researchers keep some information private to protect details about the new treatment. They have promised to release all details later.

Who can take part in this study?

Currently, we know the study is looking for men aged between 30 and 65 years old. More specific requirements will be shared later.

What will happen if I join the study?

While full details aren't known, you would likely have regular check-ups, potentially receive the new treatment, and be monitored closely. The aim is to check the treatment's safety.

Will I receive treatment for an illness?

Phase I trials primarily focus on safety and how the body processes the new medicine, not on treating a specific disease. Any benefit to an illness is secondary at this stage.

How to find out more

Regulatory Affairs Department

regulatory.affairs@shionogi.eu +44 (0)20 3053 4200 Official trial record

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