Study of safety, tolerability, pharmacokinetics and pharmacodynamics of MSD-001 in healthy participants
This is an early-stage research study, often called Phase 1. It's the first time the new medicine, MSD-001, will be given to people. We are inviting healthy adult volunteers to take part. The main aim is to understand if the medicine is safe and well-tolerated, meaning if it causes any unwanted side effects. We also want to see how the body processes the medicine (how it’s absorbed, broken down, and leaves the body) and what effects it has on the body. This kind of study is important for developing new treatments, especially for conditions like mental health disorders, though this specific study is just about the fundamental properties of the drug in healthy individuals.
At a glance
What is this study about?
Imagine scientists have developed a brand new key and they want to see if it fits the lock. That's a bit like what this research study is doing, but with a new medicine called MSD-001. This is a very early step in bringing a new medicine to people who might need it. We’re inviting healthy adults, aged 18 and older, to help us out.
The main goal of this particular study isn't to treat an illness, but to understand the basics of how MSD-001 works in the human body. We'll be looking at things like whether it's safe to take, what side effects it might cause, and how much of it stays in the body and for how long. We also want to see if it has any noticeable effects on how the body functions.
Studies like this are really important. They help researchers decide if a new medicine is promising enough to be studied further in people who actually have the condition it's designed for, such as mental health disorders. Without these first steps, new treatments couldn't be developed.
Key takeaways
- This is a very early study of a new medicine (Phase 1).
- It's about checking if a new medicine (MSD-001) is safe for people.
- Healthy adults, aged 18 and over, can take part.
- The study helps us understand how the new medicine works in the body.
- Participation contributes to developing new treatments for mental health.
- You can stop taking part at any time.
Who may be eligible?
To join this study, you need to be a healthy adult, meaning 18 years old or older. Both men and women are welcome to take part. Since this is a study for healthy volunteers, the research team will ask you questions and do some tests to make sure you don't have any significant health problems.
The reason for including only healthy people at this stage is to get a clear picture of how the new medicine works without other health conditions making it complicated. This helps us understand the medicine's basic effects before we try it in people who are unwell. If you have any ongoing health issues or take regular medication, it's very important to discuss this with the study team.
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 considered a healthy adult?
- Are you comfortable potentially staying at a clinic for a period?
- Are you able to attend regular appointments for checks?
- Are you interested in helping medical research?
What does participation involve?
If you decide to join this study, you would first have a screening visit. This involves checking your general health through tests like blood samples, a physical exam, and an overview of your medical history. If you're suitable, you would then receive the study medicine, MSD-001. It's likely this would involve staying in a clinic for a short period, or coming for regular visits over a set number of weeks or months.
During your participation, the research team would closely monitor your health. This could involve more blood tests, checking your blood pressure and heart rate, and asking you how you're feeling. The total time you spend in the study, including follow-up appointments after you stop taking the medicine, would be explained to you in detail before you agree to take part.
Potential risks and benefits
Locations (1)
- —UnverifiedNetherlands
Common questions
What is MSD-001?
MSD-001 is a new medicine that's being tested for the very first time in people. We don't know much about it yet, which is why we're doing this study.
Why are you looking for healthy people?
In these early studies, we start with healthy volunteers to understand how the new medicine works in a body without other health problems, which helps us see its effects clearly.
Will I get paid for taking part?
Sometimes, studies that involve healthy volunteers offer payment for your time and travel. The study team will be able to tell you if this is the case for this specific study.
What are 'mental health disorders'?
Mental health disorders are a range of conditions that affect your mood, thinking, and behaviour, like depression or anxiety. This new medicine might one day help treat them.
Can I stop the study if I want to?
Yes, absolutely. You can decide to leave the study at any time, for any reason, and it won't affect any medical care you might need in the future.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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