Randomized, open-label clinical trial (Phase 1) to evaluate safety, tolerability, pharmacokinetics and food effects of a single dose of IM-250 in healthy volunteers
This study is an early research step for a new medicine named IM-250. We are inviting healthy volunteers, aged 18 and over, to take part. The main goals are to check if IM-250 is safe when given as a single dose, how well people tolerate it (meaning if they have any side effects), and how the body processes the medicine. We'll also see if eating food affects how IM-250 works in the body. This is a "Phase 1" study, which means it's one of the very first times this medicine is being tested in people. It's a key step to understand if it can then be studied further for specific health conditions in the future.
At a glance
What is this study about?
Imagine scientists have developed a brand new medicine, a bit like creating a new recipe for the first time. Before it can ever be used to treat illnesses, they need to make sure it's safe for people. That's exactly what this study, called a "Phase 1" trial, is designed to do for a medicine known as IM-250.
In this study, we're asking healthy volunteers to help us. Healthy volunteers are people who don't have any major medical conditions, which helps us to see very clearly how the new medicine affects the body without other health problems confusing the results. They'll receive a single dose of IM-250, and our medical team will then carefully watch to see if there are any side effects and how the body reacts to the medicine.
We're also interested in something called "food effects." This means we want to know if taking IM-250 with food or on an empty stomach makes a difference to how the medicine is absorbed and used by your body. This information is really important because it helps us understand the best way for people to take IM-250 in the future. The information we gather will decide if this new medicine can move on to bigger studies to see if it can help people with specific health problems.
Key takeaways
- This is an early-stage study testing a new medicine called IM-250.
- It's open to healthy adults aged 18 and above.
- The main goals are to check the medicine's safety, how the body handles it, and if food affects it.
- You will receive a single dose of IM-250.
- Participation involves clinic visits for monitoring and tests.
- You can stop participating at any time.
Who may be eligible?
To be considered for this study, you need to be a healthy adult who is at least 18 years old. There's no upper age limit currently mentioned, meaning adults of any age from 18 upwards can potentially join, as long as they meet the other health criteria.
You should not have any specific medical conditions that might interfere with the study or make it unsafe for you to take the medicine being tested. The study is open to both men and women, so your gender does not affect whether you can participate.
The research team will carry out a full health check and ask detailed questions about your medical history to make sure your health is suitable for the study. This helps ensure everyone taking part is safe.
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?
- Do you consider yourself generally healthy?
- Do you not have any major ongoing medical conditions requiring regular treatment?
- Are you willing to follow study instructions, including diet restrictions if needed?
- Are you able to attend all required clinic visits?
What does participation involve?
If you decide to take part, you would receive a single dose of the study medicine, IM-250. This is done under careful medical supervision. The study team will monitor you closely for a period after you take the medicine to check for any immediate effects or side effects.
Over a set number of clinic visits, the medical team will take regular measurements, which might include blood samples and checks of your vital signs (like blood pressure and heart rate). These tests help us understand how your body handles the medicine and how quickly it leaves your system. There will also be specific times when we will look at how your body absorbs the medicine when you have eaten, compared to when you haven't.
The total amount of time you spend in the study, including all visits and follow-ups, will be explained in detail before you agree to take part. You will know the full commitment upfront.
Potential risks and benefits
Locations (1)
- —UnverifiedBulgaria
Common questions
What does 'healthy volunteer' mean?
It means you generally don't have any major ongoing illnesses or medical conditions that would affect how the new medicine works or make it unsafe for you to take part.
What is a 'single dose'?
You will only be given the study medicine one time, not multiple times over days or weeks.
What are 'food effects'?
This refers to whether taking the medicine with food, or on an empty stomach, changes how your body uses and absorbs it.
What usually happens in a 'Phase 1' study?
Phase 1 studies are the first step in testing a new medicine in humans. They mainly focus on checking if the medicine is safe and how the body handles it, rather than if it treats a specific illness.
Will I have to stay overnight at the clinic?
The study details will explain if any overnight stays are required. This information will be provided to you before you agree to take part.
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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