A study to investigate the safety, pharmacodynamics and pharmacokinetics of increasing doses of subcutaneously administered deuterated DMT (CYB004) in healthy subjects
This study is testing a new medicine called CYB004. It's a special version of a substance known as DMT. The main goals are to find out if the medicine is safe when given as injections under the skin, and to understand how it affects the body and how long it stays in the system. We'll be giving different amounts of the medicine to healthy volunteers to see these effects. This early-stage research is important because medicines like CYB004 are being explored as potential treatments for conditions such as depression and anxiety. This study is the first step to understanding if it could eventually be helpful for patients.
At a glance
What is this study about?
This research study is about a new investigational medicine called CYB004. Think of CYB004 as a specially modified version of something called DMT. Researchers are keen to see if this new version could eventually be used to help people who have depression or anxiety problems. This is a very early study, meaning it's one of the first times this specific medicine is being tested in people.
The main things the researchers want to find out are quite simple: Firstly, they want to check if CYB004 is safe when given as an injection under the skin. Secondly, they want to understand how the medicine behaves inside the body – for example, how much of it reaches the bloodstream and how long it stays there. They also want to see what effects it has on the body at different doses. By giving different amounts of the medicine to healthy volunteers, they can learn a lot about how it works.
This type of study is called a 'Phase I' trial. It's like the very first step in a long journey to develop a new medicine. Even though the medicine is being tested in healthy people now, the information gathered is crucial. It helps scientists decide if it's safe enough to continue testing in people who actually have conditions like depression or anxiety in the future. Learning about CYB004's safety and how it works is vital for potentially developing new ways to treat these mental health conditions.
Key takeaways
- This study is testing a brand new medicine called CYB004.
- It's primarily looking at the safety and how the medicine works in healthy individuals.
- The medicine is given as an injection under the skin.
- Only healthy female volunteers, 18 years or older, are being considered for this specific study.
- Findings from early studies like this are crucial for developing future treatments for depression and anxiety.
Who may be eligible?
To join this study, participants need to be adults, aged 18 years or older. There is no upper age limit mentioned. At this stage, the study is specifically looking for healthy female volunteers.
Being 'healthy' means that you don't have any major ongoing medical conditions that could affect how the medicine works or put you at extra risk. The research team will do a thorough health check to make sure it's safe for you to take part.
If you are a woman and are 18 years or older, and generally feel well, you might be a good fit for this study. The researchers will discuss all the requirements with you in detail.
- Are you 18 years old or older?
- Are you female?
- Do you consider yourself generally healthy?
- Are you comfortable with receiving injections under the skin?
- Are you able to attend several clinic visits for assessments?
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 in this study, you would first have a screening visit to check your health and make sure you're suitable. If you qualify, you would then receive the study medicine, CYB004, as an injection under your skin. You would be given different doses over time. You would need to attend several visits to the study clinic, where researchers would take measurements, blood samples, and check your overall health and how you're feeling. These visits help them understand how the medicine is affecting your body. There would also be follow-up appointments after you've received the medicine to monitor your health. The total duration of your involvement, including all visits and follow-up, would be explained clearly by the study team.
Potential risks and benefits
Locations (1)
- —Netherlands
Common questions
What is CYB004?
CYB004 is a new, investigational medicine that is a modified version of DMT. It's being studied to see its safety and effects in the body.
What is the purpose of this study?
The study aims to understand if CYB004 is safe when given by injection and how it works in the bodies of healthy people.
Will I get better if I have depression or anxiety?
This study is for healthy volunteers and is not designed to treat depression or anxiety. It's an early step to see if the medicine could eventually be used for those conditions.
How will the medicine be given?
The medicine, CYB004, will be given as injections under the skin.
Can I leave the study if I change my mind?
Yes, you are free to leave the study at any time without giving a reason, and it won't affect your future medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.