A randomised, double-blind, placebo-controlled phase Ib trial evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple doses of ACD856 in healthy participants
This study is a Phase 1 trial, which means we are carefully testing a new medicine called ACD856 for the first time in healthy volunteers. Our main goals are to check if the medicine is safe, to see how people tolerate different doses, and to understand how the body processes it. We'll also look at what effects the medicine has. The information we gather from this early research is really important. It helps us decide if ACD856 is safe enough to be tested in people who actually have conditions like depression, problems with thinking and memory (cognitive dysfunction), or Alzheimer's disease. This is a crucial step in developing new treatments that could one day make a real difference.
At a glance
What is this study about?
Imagine your brain is like a super-smart computer. Sometimes, certain parts of this computer don't work as well as they should. This can lead to problems with mood, like in depression, or issues with memory and thinking, which happen in conditions like Alzheimer's disease.
This study is about a new medicine called ACD856. Researchers hope that this medicine might be able to help the brain function better. But before it can be given to people who are unwell, we need to understand a lot more about it. This study is the very first step in that journey. It's called a 'Phase 1' study, which means we are testing it in healthy people, not those with an illness, to make sure it's as safe as possible and to understand how it works in the body.
During the study, we will give participants either the new medicine (ACD856) or a dummy medicine (a 'placebo'). Neither you nor the study team will know who gets what until after the study is finished. This helps us get the most accurate results. We'll be looking carefully at how your body handles the medicine, whether it causes any side effects, and how much of it stays in your system over time. All of this information is vital for deciding if ACD856 could be a promising new treatment for brain-related conditions in the future.
Key takeaways
- New medicine called ACD856 is being tested in healthy volunteers.
- The main goals are to check safety and how the body uses the medicine.
- The study is 'double-blind' – neither you nor the doctor knows if you get the real medicine or a dummy pill.
- This early stage research is vital for developing future treatments for brain conditions.
- You would receive close medical supervision throughout your participation.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To join this study, you would generally need to be a healthy adult aged 18 or older. This study is open to both men and women. The researchers are looking for people who don't have any major medical problems, as the goal is to understand how the new medicine works in a healthy body before testing it in people who are unwell.
There will be a more detailed list of things that could mean you can’t take part. These might include having certain health conditions, taking particular medications, or other factors that could affect your safety or the study's results. A doctor on the study team would carefully check your medical history to make sure it's safe for you to participate.
- Are you 18 years old or older?
- Are you generally in good health?
- Are you comfortable with regular medical check-ups and blood tests?
- Are you able to attend appointments at the study clinic?
- Are you potentially able to stop taking certain medications if required?
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 would first have a screening visit to check if you are suitable. If you qualify, you would receive either the study medicine (ACD856) or a dummy medicine (placebo). This would involve taking single doses initially, followed by multiple doses over a period. You would have regular check-ups and medical tests, such as blood tests, to see how your body is reacting and to monitor the medicine levels. The study team would track any side effects you might experience. The total duration of your participation would involve a number of visits to the clinic, and possibly some follow-up calls, over several weeks or months, depending on the specific schedule of doses and checks.
Potential risks and benefits
Locations (1)
- —Sweden
Common questions
What is a 'Phase 1' study?
Phase 1 is the first stage of testing a new medicine in people. It's usually done in healthy volunteers to check if the medicine is safe and how the body handles it.
What does 'double-blind' mean?
It means neither you nor the doctors giving you the medicine will know if you're getting the actual medicine or a dummy pill (placebo). This helps make the study fair and accurate.
Why apply to healthy people for conditions like Alzheimer's?
Testing in healthy people first helps us understand the medicine's basic safety and how it works in the body before we introduce it to people who are already unwell. This reduces risks for patients.
Will I get paid for taking part?
Many clinical trials offer some payment for your time and expenses. This would be fully explained before you agree to join.
What if I experience side effects?
The study team will monitor you very closely. If you experience any side effects, you should tell the study doctor or nurse immediately, and they will provide care and advice.
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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