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Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study on the effects of a new drug on the sensitivity of the nerves in healthy volunteers

This is an early stage research study, often called a Phase 1 trial, and it's looking at a new medicine. The main goal is to understand how this new medicine affects the nerves in healthy adult volunteers. Researchers want to see if it changes how sensitive nerves are, which could be important for conditions where nerves are too active or 'hyperexcitable'. By studying healthy people first, they can learn about the medicine's effects and safety before it's tested in people with specific health problems. It's a way to gather important information about how the medicine works in the body.

At a glance

Status
Ongoing, recruiting
Phase
Human Pharmacology (Phase I)- Other
Sponsor
Quralis Corp.
Enrolment target
24
Start
05 Sep 2024

What is this study about?

Imagine your body's nerves are like tiny electrical wires sending messages. Sometimes, these wires can become too 'sensitive' or 'overactive' – medical professionals call this 'hyperexcitability'. This can lead to various uncomfortable feelings and conditions. Researchers are developing a new medicine that they hope might help to calm these overactive nerves.

This particular study is a very early step in testing this new medicine. It's called a 'Phase 1' study, and its main purpose is to see how the medicine acts in the body and if it's safe. Instead of testing it on people who already have health problems, they're looking for healthy volunteers. This helps them understand the basic effects of the medicine without other health conditions making it complicated.

By taking part, healthy volunteers will help scientists understand if this new medicine can affect nerve sensitivity and how their bodies react to it. This information is really important because it lays the groundwork for future studies that might one day help people suffering from conditions caused by overactive nerves.

Key takeaways

  • This is an early study of a new medicine for overactive nerves.
  • It's looking at how the medicine works in healthy adults.
  • It helps gather important safety information.
  • Your participation could help future patients.
  • You'll be carefully monitored throughout the study.

Who may be eligible?

To join this study, you need to be a healthy adult aged 18 or older. Both men and women are welcome to take part. Since this is an early study, they are looking for people who are generally well and don't have any significant health issues that might affect how the new medicine works or make it unsafe for them.

The research team will carry out several checks to make sure you are suitable and that participating would be safe for you. This will usually involve looking at your medical history and doing some health tests. It's important that you openly share all relevant health information with the study team.

Quick self-check
  • Are you 18 years old or older?
  • Are you generally in good health?
  • Are you male or female?
  • Are you willing to attend regular study visits?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you'll be given the new medicine under careful supervision. This study will involve a series of visits to the research clinic. During these visits, the study team will monitor your health closely, take blood samples, and perform other tests to see how your body is reacting to the medicine and if it's affecting your nerves. The total duration of your involvement, including all visits and follow-up, will be explained in detail by the study team. You will have plenty of opportunities to ask questions about what's involved before you commit.

Potential risks and benefits

The potential benefit of taking part is contributing to medical science and helping develop new medicines that could one day help people with nerve conditions. However, like all medicines, this new drug may have some side effects, which could be mild or, in rare cases, more serious. The research team will explain all known or potential risks to you. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

  • Netherlands

Common questions

What does 'hyperexcitability nerve disorder' mean?

It's a medical term for conditions where your nerves are unusually sensitive or too active, which can cause various symptoms.

Why are healthy volunteers needed for this study?

Studying healthy people helps researchers understand how the medicine works in the body and its basic safety without other health problems complicating the results.

Will I be paid for taking part?

Payment for participation or reimbursement for expenses varies by study. The research team will give you all the details on this.

What happens if I change my mind after joining?

You are free to leave the study at any time, for any reason, without it affecting your medical care or relationship with your doctor.

How long will I be involved in the study?

The total time you'll spend in the study, including all your visits, will be clearly explained by the research team before you agree to take part.

How to find out more

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

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