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Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

A study of the safety of the new investigational drug CVN293 in healthy volunteers, and how CVN293 is taken up and processed by the human body.

This study is about a brand-new medicine, called CVN293, which hasn't been given to people before. The main goal is to check if it's safe for healthy volunteers to take. Researchers also want to understand how the body absorbs, uses, and gets rid of CVN293. This is the very first step in testing a new medicine in humans. The medicine is being developed to potentially help people with 'neurodegenerative disorders'. These are conditions that affect the brain and nerves over time, like Alzheimer's or Parkinson's, although this study isn't treating those conditions directly. Finding out if CVN293 is safe is a crucial first step for future research into these types of illnesses.

At a glance

Status
Ongoing, recruiting
Phase
Human Pharmacology (Phase I)- First administration to humans
Sponsor
Cerevance Inc.
Enrolment target
64
Start
15 Aug 2023

What is this study about?

This research study is focused on a brand-new medicine, which for now is called CVN293. This is the very first time CVN293 will be given to people. The main aim of a study like this is to carefully check if the new medicine is safe. Researchers will be giving CVN293 to healthy volunteers, not people with an illness, to see how their bodies react to it.

Another really important part of this study is to understand how the body handles CVN293. This means finding out how much of the medicine gets into the blood, how long it stays there, and how the body eventually gets rid of it. This information is key because it helps scientists work out the right dose to use in the future, and how often a medicine might need to be taken.

While this study is for healthy people and isn't designed to treat any illness, the new medicine, CVN293, is being developed because it might one day help people with 'neurodegenerative disorders'. These are serious conditions that affect the brain and nerves, causing problems with things like memory, movement, or thinking, which can get worse over time. Finding out if CVN293 is safe for people is a vital first step in the long process of developing new treatments for these challenging conditions.

Key takeaways

  • This is the first time a new medicine, CVN293, is being given to people.
  • The main goals are to check if CVN293 is safe and how the body handles it.
  • The study needs healthy adults (18+) as volunteers.
  • It could help future treatments for brain and nerve conditions.
  • Participation involves clinic visits and careful health checks.

Who may be eligible?

To join this study, you need to be a healthy adult aged 18 or older. Both men and women can take part. This study is specifically looking for people who are generally well and don't have any major ongoing health problems.

Because this is the very first time this new medicine is being given to people, the research team needs to be very careful. They will check your health thoroughly to make sure taking part is safe for you. This will likely involve looking at your medical history and doing some health checks.

There will also be other specific requirements that the study team will discuss with you. These could be things related to other medicines you take, certain medical conditions you might have had in the past, or specific lifestyle factors. It's important to discuss any health questions or concerns with the study team to see if this study is right for you.

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. Am I 18 years old or older?
  2. Am I generally healthy and don't have any major ongoing medical conditions?
  3. Am I available for multiple clinic visits, potentially including overnight stays?
  4. Am I comfortable with regular health checks, including blood tests?
  5. Am I willing to follow the study instructions carefully?
Answer every question to see your result.

What does participation involve?

Taking part in this study means you would be given the new medicine, CVN293, for the first time. You would have several visits to the study clinic, and some of these might involve staying overnight for a short period. During these visits, the research team would do various health checks. This could include taking blood and urine samples, checking your blood pressure and heart rate, and asking you about how you are feeling.

These checks are important to see how your body is reacting to the new medicine and to make sure you are safe. After you've taken the medicine, there will be follow-up appointments to continue monitoring your health. The total time you would be involved in the study, from your first visit to your last, will be explained in detail by the study team. They will also let you know how often you would need to visit the clinic and for how long each visit might be.

Potential risks and benefits

Potential benefits from taking part in this study are mainly knowing you are contributing to important medical research that could, in the future, help people with serious brain and nerve conditions. You will also receive careful medical monitoring throughout the study. However, because this is a new medicine, there are potential risks. You might experience side effects that are currently unknown, or the medicine could affect your body in unexpected ways. The research team will explain all known potential risks and side effects to you. It's very important to remember that joining a study is always your choice, and you have the right to withdraw 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.
  • Unverified
    Netherlands

Common questions

What kind of conditions is CVN293 meant for?

CVN293 is being developed to potentially help people with 'neurodegenerative disorders', which are conditions affecting the brain and nerves over time.

Will taking part in this study cure my illness?

No, this study is for healthy volunteers and not designed to treat any illness. It's about testing the safety of a new medicine.

How old do I need to be to join?

You need to be 18 years old or older to take part in this study.

Will I have to stay at the clinic?

Some visits might involve staying overnight at the clinic, but the study team will give you all the details.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time, for any reason, and it won't affect any future medical care you receive.

How to find out more

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

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