All studies
CompletedPhase IInterventional

Phase I Trial: Sponsor code: X11-201-00001

This study, known by the code X11-201-00001, is a very early stage (Phase I) clinical trial. This means it's one of the first times a new treatment is being tested in people. The main goal of these early studies is to see if the treatment is safe and to understand how it behaves in the body, rather than checking if it cures a specific illness. Because it's so new, the full details about what the study is looking at and what the treatments involve aren't available to the public yet. These details will be released within 30 months after the study has officially ended. Both men and women of all ages can potentially take part. More information will become available in due course.

At a glance

Status
Completed
Phase
Phase I
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Enrolment target
72
Start
31 Mar 2025
Estimated completion
06 May 2026

What is this study about?

This clinical trial is called X11-201-00001, and it's a very early-stage study, known as 'Phase I'. When new treatments are developed, they go through several stages of testing. Phase I is usually the first time a new medicine or treatment is given to people. The main purpose at this stage is to find out if the treatment is safe and to understand what dose might be appropriate.

Because this is such an early step, the organisers of the study have decided not to share all the specific details about the conditions it's investigating or the exact treatments being used just yet. This is quite normal for Phase I trials, to protect the privacy of the research and any new discoveries.

All the detailed information will be made public within 30 months after the study has completely finished. This ensures transparency while allowing the researchers to conduct their initial work without immediately revealing all their methods. It's a careful process designed to ensure new treatments are thoroughly checked before they can be more widely used.

Key takeaways

  • This is a very early (Phase I) study of a new treatment.
  • The main goal is to check the treatment's safety.
  • Full details about the study are not yet public but will be released later.
  • Both men and women of all ages may be eligible.
  • Potential personal benefit is not the primary aim at this early stage.
  • You can withdraw from the study at any time.

Who may be eligible?

At this very early stage, the full details about who can join this study are not publicly available yet. This includes specific health conditions that might allow you to join (inclusion criteria) or reasons why you might not be able to participate (exclusion criteria).

What we do know is that this study is open to both men and women, and people of all ages can be considered. However, even within these broad categories, there will be specific medical requirements that need to be met.

Once the full details are released, you would be able to see if your own health situation matches what the researchers are looking for. For now, if you are interested in this type of research, you would need to speak with your doctor or the study team directly for the most up-to-date and specific guidance on eligibility.

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 male or female?
  2. Are you of any age?
  3. Are you willing to speak with the study team to learn more specific health requirements?
  4. Are you aware that full details on who can join are not yet released?
Answer every question to see your result.

What does participation involve?

Since the full details of this study are not yet public, we can't tell you exactly what taking part would involve. In a typical early-stage (Phase I) study like this, participants usually attend regular appointments at a clinic or hospital. These visits often include checks like blood tests, physical examinations, and scans to monitor health and see how the new treatment is affecting the body. You would likely be given a new medicine or treatment, and the study team would closely watch for any side effects.

The number of visits, how long you stay at each visit, and the total length of the study vary greatly. There would also be a follow-up period after you stop taking the treatment to ensure your well-being. All participants have the right to withdraw from the study at any time, for any reason, without it affecting their usual medical care.

Potential risks and benefits

In early-stage (Phase I) trials like this one, potential benefits to participants are not the main goal. The main aim is to understand safety and how the treatment works, which could help future patients. There's a chance you might not personally benefit from the new treatment being tested. As with any new medicine, there are potential risks, including side effects that are not yet fully known. The study team would carefully explain all known and potential risks before you decide to join. Remember, you can also decide to leave the study at any time without giving a reason, and your medical care will not be affected.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • MAC Clinical Research, Early Phase Unit
    City only
    Manchester, Greater Manchester, England
  • MAC Clinical Research Centre
    Unverified
    Prescot, Merseyside, England

Common questions

What does 'Phase I Trial' mean?

It means this is one of the first times a new treatment is being tested in people, primarily to check if it's safe and to understand how it works in the body.

Why can't I see all the details now?

Because it's such an early stage, the study organisers are keeping some information private for now. All details will be released within 30 months after the study finishes.

Who can take part in this study?

The study is open to both men and women, of all ages. However, more specific health requirements will apply, but those details aren't public yet.

Will I get better if I join this study?

The main goal of Phase I studies is to check safety, not usually to cure an illness. While some people might feel better, it's not guaranteed, and personal benefit isn't the primary aim.

Can I leave the study if I change my mind?

Yes, absolutely. You have the right to leave the study at any point, for any reason, without it affecting your regular medical care.

How to find out more

Neel Bhatt

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

Discussion

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