All studies
RecruitingPhase IInterventional

Phase I Study (QSC303441)

This is a very early study, open to healthy people between 18 and 55 years old. It's called a 'Phase 1' trial, which means researchers are likely testing a new treatment or medicine for the first time in humans to check how safe it is and how the body handles it. At this moment, the full details of what exactly will happen in the trial are not available. This is quite common for early studies, and the full information will be officially published about 30 months after the study has finished. Both men and women can take part if they are in good health.

At a glance

Status
Recruiting
Phase
Phase I
Sponsor
Novartis Pharmaceuticals UK Ltd.
Enrolment target
102
Start
23 Dec 2025
Estimated completion
12 Jun 2027

What is this study about?

This study is an early-stage medical investigation, often called a 'Phase 1' trial. In these types of studies, researchers usually look at a new drug or treatment that hasn't been widely used in people before. Their main goals are typically to check if the treatment is safe, to understand what dose might be appropriate, and to see how the body reacts to it. Because it's an early-stage study, it's open to healthy volunteers, meaning people who don't have any major health conditions.

At the moment, the full details of what this study involves are not public. This isn't unusual for very early trials. The organisation running the study has decided that the complete information will be made available to everyone about 30 months after the trial has come to an end. This waiting period allows them to complete their analysis without revealing too much sensitive information too soon, which is allowed under research guidelines.

Once the study is finished and the waiting period is over, all the detailed information, including exactly what was tested and the full medical title of the study, will be published. This ensures transparency in research, making sure that future patients and doctors can learn from the findings.

Key takeaways

  • Early stage 'Phase 1' study, likely testing a new medicine's safety in people.
  • Open to healthy volunteers, both men and women, aged 18 to 55.
  • Full study details will be published later, around 30 months after the study ends.
  • Participation will involve health checks, receiving a study treatment, and close monitoring.
  • Your contribution could help advance medical science.

Who may be eligible?

This study is looking for healthy adults. To take part, you need to be aged between 18 and 55 years old, including both your 18th and 55th birthdays. Both men and women can join the study.

Because this is an early study, there will be very specific health checks to make sure you are in good general health. If you have any ongoing medical conditions, take regular medication, or have certain past health issues, you might not be able to join. The researchers will carry out careful checks to see if you are a good fit for the study.

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.

  1. Are you between 18 and 55 years old?
  2. Are you generally in good health?
  3. Do you have any ongoing medical conditions?
  4. Do you take any regular medication?
Answer every question to see your result.

What does participation involve?

As the full details of this study are not yet public, we can only give you general information about what taking part in a Phase 1 study usually involves. Typically, you would have an initial screening visit where doctors check your health with tests like blood pressure, blood tests, and a physical exam.

If you qualify, you would then receive the study medicine, likely at a research clinic. This might involve staying overnight or making several visits over a period of days or weeks. During this time, the research team would closely monitor you for any side effects and take samples (like blood or urine) to see how your body handles the treatment. There would also be follow-up appointments after you stop taking the medicine to ensure you remain well. The total duration of your involvement could range from a few weeks to a few months, depending on the study design.

Potential risks and benefits

Taking part in any medical study has both potential benefits and risks. You might not directly benefit from this early-stage study, as its main purpose is to gather information about a new treatment, not to treat a specific illness. However, you would be contributing to medical science, potentially helping to develop new treatments for future patients. Potential risks could include side effects from the study medicine, which might be mild (like headaches or nausea) or, less commonly, more serious. There might also be discomfort from blood tests or other procedures. You would be fully informed of all known risks before deciding to join, and you can choose to leave 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, England

Common questions

What is a 'Phase 1' study?

It's an early-stage research study, often the first time a new medicine is tested in people, usually to check its safety and how the body handles it.

Why are the full study details not available yet?

It's common for early trials to delay publishing full details. The full information will be made public about 30 months after the study finishes.

Who can join this study?

Healthy adult men and women between the ages of 18 and 55.

Will I get paid to take part?

Information about payment for participation is not public, but some healthy volunteer studies offer compensation for time and travel.

What if I change my mind after joining?

You are free to leave the study at any point, for any reason, and it won't affect your future medical care.

How to find out more

Novartis Study Director

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

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.