Not yet recruitingPhase IInterventional

Deferred registration - Phase I trial - Quotient Sciences code: QSC303633

This is an early-stage research study, known as a Phase 1 trial, and we're looking for healthy volunteers aged between 18 and 55 years old to take part. At this moment, the full details of what the study involves are not yet available to the public. This sometimes happens with very new research to protect information while the study gets started. We expect that more specific information, including what the treatment is and what participants will be asked to do, will be made available when the study is further along. The main goal of a Phase 1 trial is to learn about the safety of a new medicine or treatment and how it behaves in the human body, rather than whether it can treat a specific illness.

At a glance

Status

Not yet recruiting

Phase

Phase I

Sponsor

Alkermes, Inc

Enrolment target

Start

18 Jun 2026

Estimated completion

05 Dec 2026

Healthy volunteers

What is this study about?

This study is an early step in testing a new treatment or medicine. It's called a 'Phase 1' trial, which means it’s one of the first times researchers will give this treatment to people, not patients with a specific illness, but healthy volunteers. The main aim at this stage is to understand if the treatment is safe and how our bodies handle it. Researchers will carefully check things like how much of the treatment stays in the body, how quickly it leaves, and what side effects, if any, it might cause.

Because this is such an early study, some of the specific details about the treatment itself, what it's for, and exactly what participants will be asked to do are not yet publicly available. This is a common practice to allow researchers to protect new discoveries while the study is in its very first stages. Don't worry, all necessary information would be fully shared with anyone considering joining before they make a decision.

The information from studies like this is really important for developing new medicines. It helps scientists decide if a treatment is safe enough to move on to the next stages of research, where it might then be tested on people with a particular health condition. Your participation as a healthy volunteer helps pave the way for potential future treatments.

Key takeaways

This is an early-stage (Phase 1) study for a new treatment.
It's looking for healthy volunteers, aged 18-55, of any gender.
The main goal is to test the safety of the new treatment.
Full details of the study will be available at a later date.
Your participation helps advance medical research.

Who may be eligible?

This study is specifically looking for healthy people, not those with an existing medical condition. You must be an adult, aged between 18 and 55 years old, to be able to take part.

Because the full information for this study is not yet public, we don't have the exact details about who might not be able to join. However, typically in these types of studies, researchers would look for people who are generally well, not taking certain medications, and don't have any serious ongoing health issues.

Once the full study details are shared, you would be provided with a complete list of things that might prevent you from taking part, such as specific health conditions or medications you might be using. This ensures everyone's safety.

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 generally healthy with no serious medical conditions?
Are you able to commit to potential clinic visits?
Are you comfortable with the idea of taking a new, untested treatment?
Are you open to having regular health checks (like blood tests)?

Answer every question to see your result.

What does participation involve?

Since the full details for this study aren't yet available, we can't give you a step-by-step guide on what taking part would involve. However, generally for a Phase 1 study in healthy volunteers, you could expect:

* **Screening Visits:** You'd likely have at least one visit where doctors and nurses would check your health with tests like blood pressure, blood samples, urine tests, and a physical exam to make sure you're suitable. * **Treatment Period:** If you qualify, you would receive the study treatment. This might involve staying overnight at a clinic for a few days, or coming for several shorter visits. The treatment could be given as tablets, an injection, or another method. * **Assessments:** During and after receiving the treatment, researchers would regularly check your health. This usually includes blood tests, urine tests, heart recordings (ECG), vital signs, and answering questions about how you feel. * **Follow-up:** After the main treatment period, there would typically be one or more follow-up visits to ensure you're well and to continue monitoring for any effects of the treatment.

The total duration of your involvement could range from a few days to several weeks, depending on how long the researchers need to monitor the treatment in your body. All of these details would be fully explained to you before you agree to participate.

Potential risks and benefits

Taking part in any research study has potential benefits and potential risks. The main benefit of Phase 1 studies is helping to advance medical knowledge and contribute to the development of new treatments for others in the future. While there's no direct personal health benefit for you, your participation is invaluable to science. Potential risks could include side effects from the experimental treatment, which might be mild like a headache or tiredness, or in rare cases, more serious. All known and potential risks would be fully explained to you before you agree to take part. It's very important to remember that participating is always your choice, and you 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
Unverified
Nottingham, England

Common questions

What does 'Phase 1 trial' mean?

A Phase 1 trial is the very first stage of human testing for a new medicine. It focuses on checking if the medicine is safe and how the body handles it, usually in healthy volunteers.

Why aren't all the study details available yet?

Sometimes, for very new research like this, full details are kept private in the early stages to protect new discoveries. All information will be shared before anyone decides to join.

Will I get 'better' from taking part?

Since this study is for healthy volunteers and not aimed at treating an illness, there's no direct health benefit for you. However, your involvement helps medical science advance.

Are men and women allowed to participate?

Yes, both men and women over the age of 18 and up to 55 years old are welcome to consider taking part in this study.

What happens if I change my mind?

You are always free to leave the study at any point, for any reason, without needing to explain why. It will not affect any healthcare you receive.

How to find out more

Director Global Clinical Services

clinicaltrials@alkermes.com 15715992702 Official trial record

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