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Phase I Study (PHU-001)

This is an early research study, known as a Phase I trial. In these types of studies, researchers usually test a new treatment or medicine for the first time in a small group of people. The main goal is often to see if it's safe, figure out the right dose, and check for any side effects. At the moment, the full details of this specific study are not available to the public. This is a common practice in early-stage research. The good news is that all the information, including exactly what they are studying and who can take part, will be made public within 30 months after the study has officially come to an end. It's open to adults aged 18 to 90, for all genders.

At a glance

What is this study about?

This study is a 'Phase I' trial. In medical research, studies like this are the very first step when a new treatment or medicine is being explored in people. The main aims of a Phase I study are usually to check if the new treatment is safe, to find the best dose, and to see how the body reacts to it. It's a really important stage, helping researchers learn fundamental information before moving on to larger studies.

At this time, many of the specific details about what this study is investigating, such as the exact condition it's for or the treatment being tested, are not yet public. This isn't unusual for early-stage trials. The organisation running the study has decided to keep these details private for a set period.

However, it's reassuring to know that all the information will eventually be made available. Within 30 months after the study has completely finished, a full report with all the scientific details will be shared. This commitment ensures transparency in the long run, even if the information isn't immediately available.

Key takeaways

  • This is an early-stage (Phase I) medical research study.
  • The main focus of Phase I studies is usually safety and finding the right dose of a new treatment.
  • Full details of this study are currently confidential but will be released publicly within 30 months after it finishes.
  • Anyone aged 18 to 90, regardless of gender, could potentially be eligible.
  • You would be closely monitored for safety if you joined, and you can withdraw at any time.

Who may be eligible?

To join this study, you must be an adult. This means you need to be at least 18 years old. The study is open to older adults too, up to the age of 90 years.

Whether you are male or female, you can be considered for this study, as it is open to all genders.

Beyond these age and gender requirements, the full list of other health conditions or medications that might make you suitable or unsuitable for this study are not yet publicly known. These details will be released once the study is complete, within 30 months.

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 90 years old?
  2. Are you comfortable with the idea that specific study details aren't public yet?
  3. Are you prepared to attend multiple appointments and undergo medical tests?
  4. Are you generally in good health, or do you have a specific condition that a new treatment might target (once details are known)?
Answer every question to see your result.

What does participation involve?

Because the full details of this study are not yet public, we don't have information on what taking part would specifically involve. However, in a typical Phase I study, you might:

* Have several clinic visits for health checks, blood tests, and possibly scans. * Receive the study treatment, which could be a new medicine or therapy. * Undergo regular assessments to see how you're responding and to monitor for any side effects. * Have follow-up appointments after you stop the main treatment, to ensure your health is stable.

The overall duration of participation would be explained during the consent process, but could range from weeks to several months depending on the treatment and monitoring required. All these specifics would be clearly explained if you were invited to participate.

Potential risks and benefits

Participating in any research study comes with potential benefits and risks. For a Phase I study, potential benefits are usually indirect, contributing to medical knowledge that might help others in the future. There's a chance you might personally benefit from a new treatment, but this is not guaranteed, and the main goal is often safety. Potential risks could include side effects from the experimental treatment, which are not fully known beforehand. However, your safety is paramount, and you would be closely monitored. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Portsmouth Hospitals University NHS Trust
    City only
    Portsmouth, England

Common questions

What is a 'Phase I' study?

It's the first stage of testing a new treatment in people, focusing on safety, dosage, and how the body handles it.

Why aren't all the details available yet?

For early-stage studies, it's common for some details to be kept private for a period. This will be released later.

When will the full study details be available?

All the details, including what was studied and who could take part, will be made public within 30 months after the study has ended.

Who can take part in this study?

Adults between 18 and 90 years old, of any gender, can potentially take part. Other specific criteria are not yet known.

Will I get the actual medicine or just a placebo?

In Phase I studies, there's usually a focus on how people react to the new treatment itself. The study design would explain whether a placebo is used and how.

How to find out more

Guglielmo Niccolò Piozzi

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

Discussion

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