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

Testing for the first time the effects of a new medicine in healthy people

This research study is about a brand new medicine designed to help people with mental health conditions. It's the very first time this medicine is being given to humans. We're looking for healthy volunteers to help us understand how safe the medicine is and what it does in the body. This is a very early stage of testing, often called 'Phase 1'. It helps us learn important information about the medicine before it's given to people who are unwell. Our main goal is to check for any side effects and to see how the body handles the medicine, not to treat any illness yet.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Eurofins Optimed, Synendos Therapeutics AG

Enrolment target

Start

15 Jan 2024

Psychatric disorder

What is this study about?

This study is a very important first step in developing a new medicine that could one day help people with a mental health condition. Even though you might feel healthy, testing new medicines like this on volunteers helps us understand them better before they can be used more widely. It’s a bit like testing a new car engine in a controlled environment before putting it into a car on the road.

In this study, we're focusing on how safe the new medicine is and how your body reacts to it. We need to learn if it causes any unexpected side effects and how long it stays in your system. This kind of early testing is crucial because it helps us make sure that any future studies involving people with the actual condition are as safe as possible.

Your participation would provide vital information, helping researchers learn whether this new medicine could potentially become a helpful treatment option in the future. It's a fundamental part of bringing new medicines from the laboratory to patients who might need them.

Key takeaways

This is the first time this new medicine is being tested in humans.
The study is for healthy volunteers aged 18 and over.
It aims to check the medicine's safety and how it works in the body.
Your health will be closely monitored by doctors and nurses.
You won't directly benefit from the medicine, but you'll help future patients.
You can stop participating at any time.

Who may be eligible?

This study is looking for healthy adults. You must be at least 18 years old to take part. There is no upper age limit, as long as you are generally healthy.

Both men and women are welcome to join this study. The most important thing is that you are in good general health, as this helps us understand how the new medicine works without other health problems getting in the way.

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 18 years old or older?
Are you generally healthy, without any serious ongoing medical conditions?
Are you comfortable potentially taking a new medicine that has never been given to people before?
Are you able to commit to the required clinic visits and follow-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the new medicine for the first time. This would involve regular check-ups at a clinic, where doctors and nurses will carefully monitor your health. They will measure things like your heart rate, blood pressure, and take blood or urine samples. You might also be asked about how you are feeling. Throughout the study, the research team will be there to explain everything and answer any questions. The total duration of your involvement, including follow-up visits after taking the medicine, will be clearly explained to you before you agree to take part.

Potential risks and benefits

Taking part in any medical study carries some potential risks. As this is a new medicine, there is a chance of experiencing side effects that are not yet fully known. However, you will be closely monitored by medical staff to ensure your safety. On the benefit side, you won't directly gain health improvements from this medicine, but you will be contributing to valuable medical research that could help many people in the future. You are always free to change your mind and 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.

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Unverified
France

Common questions

What does 'healthy volunteers' mean for this study?

It means we're looking for people who don't have any major ongoing health problems, especially not the mental health condition the medicine is intended for. This helps us see the medicine's effects clearly.

Will I become addicted to the medicine?

The research team will carefully monitor you. The study is designed to be safe, and any potential for addiction would be a major concern that would be thoroughly investigated and explained to you.

Will I be paid for taking part?

Some studies offer payment for your time and inconvenience. This will be fully explained to you before you agree to join.

What happens after the study is finished?

Once your part in the study is complete, the research team will ensure a safe final check-up. The information gathered from you and other volunteers helps decide if the medicine can move to the next stage of testing.

Can I leave the study at any point?

Yes, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.