[HIBOU] : A phase I, single-center, randomized, double-blind, single-dose escalation, placebo-controlled clinical study to evaluate the safety, tolerability and pharmacokinetics of IMP21052 administered intravenously in three groups of healthy male and female volunteers
This is an early-stage medical research study, sometimes called a Phase I trial, where we're testing a new medication named IMP21052 for the first time in people. The main goals are to check if the medicine is safe, if people can take it without too many side effects, and how it moves through and out of the body. Participants will be healthy adult men and women, starting from age 18. They will receive a single dose of the medicine, given directly into a vein. Some participants will receive a placebo, which looks like the medicine but has no active ingredients. This helps scientists compare the effects of the real medicine.
At a glance
What is this study about?
This study is a very early step in checking if a new medicine, called IMP21052, could be helpful in the future. Because it's the first time this specific medicine is being given to people, our top priority is to make sure it's safe. We also want to understand if it causes any side effects and how your body processes it.
You might be wondering why we test new medicines on healthy volunteers. It's an important part of the research process, allowing us to learn about the medicine's basic effects without other health conditions making it complicated. This information is crucial before we can even consider testing it in people who might actually need it for a specific illness.
Since no brief summary was provided, we can infer that IMP21052 is being developed as an antidote. An antidote is a medicine that can counteract the effects of a poison or another harmful substance. By studying IMP21052 at this early stage, we hope to gather fundamental knowledge that could pave the way for its future use to help people in need.
Key takeaways
- It's a very early-stage study (Phase I) of a new medicine called IMP21052.
- The main goals are to check the medicine's safety, how it's tolerated, and how the body processes it.
- Healthy adult men and women, aged 18 and over, can participate.
- Participants will receive a single dose of the medicine (or a placebo) through a drip.
- It's about helping to develop future medicines, specifically potential antidotes.
Who may be eligible?
To join this study, you need to be a healthy adult, aged 18 or older. Both men and women are welcome to take part. Being healthy means you don't have any significant ongoing medical conditions that could interfere with the safety or results of the study.
Specific details about what makes someone 'healthy enough' for this type of trial would be discussed during the screening process. This usually involves a medical check-up, blood tests, and a review of your medical history to ensure your safety throughout the study.
While the exact details of who can't join aren't listed, typically people with serious medical conditions, those taking certain medications, or pregnant/breastfeeding individuals would not be able to participate. The study team will go through all the requirements with 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 18 years old or older?
- Are you generally in good health?
- Are you a man or a woman?
- Are you able to attend study visits as required?
What does participation involve?
If you decide to take part, you'll first have a screening visit to check if you're suitable. Once confirmed, you would attend a study visit where you'll receive a single dose of the study medicine, IMP21052, given directly into your vein (intravenously). Some participants will get a placebo instead of the active medicine.
Throughout the study, nurses and doctors will regularly check your health, take blood samples, and monitor you for any side effects. These checks are to understand how your body reacts to the medicine and how it processes it. The study will likely involve staying at the clinic for a short period after you receive the dose, followed by a few follow-up appointments. The total duration of your participation, including all visits, will be explained in detail by the study team.
Potential risks and benefits
Locations (1)
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Common questions
What does 'Phase I' mean?
Phase I means this is one of the very first times this new medicine is being tested in people. The main goal is to check for safety and how the body handles it.
What is IMP21052?
IMP21052 is a new medicine being studied as a potential antidote, which is something that can counteract the effects of poisons or other harmful substances.
Will I get the actual medicine?
You might get the actual medicine or a placebo, which looks like the medicine but has no active ingredients. This is decided by chance, like flipping a coin.
How will the medicine be given?
The medicine will be given directly into your vein using a small tube, similar to when you have blood tests.
Do I have to be sick to join?
No, this study is looking for healthy male and female volunteers to help us understand how the new medicine works in general.
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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