A randomized double-blind placebo-controlled phase 1 study on the safety, tolerability and pharmacokinetics/-dynamics of escalating single intravenous doses of AK1967 (Procizumab) in healthy male volunteers
This research is looking at a new medicine named AK1967 (also known as Procizumab). It's a very early stage study, meaning it's the first time this medicine is being given to people. The main goal is to check if the medicine is safe at different doses and how healthy men's bodies react to and process it. The study is "double-blind," which means neither the participants nor the research team will know who is getting the new medicine and who is getting a dummy treatment (placebo). This helps make sure the results are fair. It's an important first step to see if this medicine could potentially help people with conditions like circulatory shock in the future.
At a glance
What is this study about?
This study is a very early but important step in developing a new medicine called AK1967, also known as Procizumab. Think of it like a new car being tested on a track for the very first time. Before it can be driven on public roads, engineers need to make sure it's safe and performs as expected. Similarly, this study is designed to understand how the medicine behaves in the human body.
The main goals are to find out if the medicine is safe for people to take, even at different dose levels. The researchers will also be watching to see how the body absorbs, processes, and gets rid of the medicine, and what effects it might have. Because it's an early study, they are using healthy volunteers, which helps them see the basic effects of the medicine without other health conditions making it complicated.
This kind of research is crucial because it helps scientists decide if a new medicine is promising enough to move on to larger studies in people who actually have the health condition it's designed to treat, such as circulatory shock. Circulatory shock is a serious medical emergency where the body isn't getting enough blood flow. By understanding how AK1967 works in healthy people first, researchers can then plan future studies to see if it could eventually help patients in need.
Key takeaways
- This is a very early safety study of a new medicine called AK1967.
- It's the first time this medicine is being given to people.
- The study aims to check how safe it is and what it does in the body of healthy men.
- You won't know if you're getting the medicine or a dummy treatment.
- Taking part helps research for serious conditions like circulatory shock.
- You can leave the study at any time.
Who may be eligible?
To be considered for this study, you must be a male and be at least 18 years old. There isn't an upper age limit mentioned, but other health checks would be done to ensure you are generally healthy enough to take part.
Because this is a study for healthy volunteers, the research team will do medical checks to confirm you don't have any serious ongoing health conditions. This helps them to see the effects of the new medicine clearly, without other illnesses getting in the way.
In general, you wouldn't be able to join if you have certain medical conditions or are taking medications that might interfere with the study medicine. The doctors will discuss all of these details with you thoroughly to make sure taking part is safe and 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.
- Are you male?
- Are you 18 years old or older?
- Are you generally healthy and don't have any major ongoing medical conditions (as confirmed by a doctor)?
- Are you able to commit to staying at a clinic for a period and attending follow-up visits?
- Are you willing to get a single dose of medicine given into your vein?
What does participation involve?
If you decide to take part, you would receive a single dose of either the new medicine (AK1967) or a dummy treatment (placebo) given directly into your vein. Neither you nor the study doctors would know which one you received. You would need to stay at the study clinic for a set period, likely a few days, after receiving the dose, so the doctors can closely monitor you.
During your time in the study, you would have regular health checks. This might include giving blood and urine samples, having your blood pressure and heart rate checked, and sharing details about any symptoms you experience. This helps the researchers understand how the medicine is working and if there are any side effects.
After you leave the clinic, there would likely be follow-up appointments over a period of weeks or months. These visits are important to continue monitoring your health and to see if there are any longer-term effects from the medicine. The full duration of your participation, from the first visit to the last follow-up, would be clearly explained before you agree to join.
Potential risks and benefits
Locations (1)
- —UnverifiedNetherlands
Common questions
What is 'Phase I' of a clinical study?
Phase I is the very first step in testing a new medicine in people. It's mainly to check if the medicine is safe and how the body handles it, usually in a small group of healthy volunteers.
What does 'double-blind' mean?
It means that neither you (the participant) nor the study doctors will know if you're getting the actual medicine or a dummy treatment (placebo). This helps make the study results more accurate.
Why are healthy volunteers needed for this study?
By using healthy volunteers, researchers can see the direct effects of the new medicine without other health conditions making the results complicated. It's the safest way to initially check its safety and how it works in the body.
What is 'circulatory shock'?
Circulatory shock is a serious medical emergency where the body's organs and tissues aren't getting enough blood flow. It can be life-threatening if not treated quickly.
Will I get paid for taking part?
Many early-stage studies for healthy volunteers offer payment for your time and travel, but this would need to be confirmed directly with the study team.
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.