A prospective, single-centre, randomised, double-blind, placebo-controlled, phase I, First-In-Human (FIH) trial evaluating the safety and tolerability of single and multiple ascending oral doses of IRL757 in healthy volunteers.
This study is an early-stage clinical trial looking at a new medicine named IRL757. It's designed for healthy volunteers to help researchers understand if the medicine is safe and how well different single and repeated doses are tolerated by the body. This is the very first time this medicine is being given to humans. Scientists hope that IRL757 could eventually be used to help people who experience a lack of motivation or interest, known as apathy, often seen in specific brain-related conditions. Participants will receive either the active medicine or a dummy pill, but neither they nor the study team will know which until the study ends. This helps ensure fair and accurate results.
At a glance
What is this study about?
Imagine feeling a big drop in motivation, energy, and interest in things you used to enjoy – this is called apathy. It's a common and difficult symptom for people living with certain brain conditions, making daily life challenging for them and their families. Currently, there aren't many good treatments specifically for apathy, which is why researchers are working hard to find new solutions.
This particular study is a very early step in testing a new medicine called IRL757. It's what we call a 'first-in-human' study, meaning it's the very first time people will take this medicine. The main goals are to carefully check if IRL757 is safe for people and to see how the body reacts to different amounts of the medicine – both single doses and repeated doses over a short period. This information is crucial before the medicine can be tested in people who actually have apathy.
Because this is such an early study, it's being conducted in healthy volunteers, not people with apathy. Participants will be randomly given either the active medicine or a 'dummy' pill (placebo) that looks the same but contains no medicine. To keep the results fair, neither the participant nor the study doctors will know who is getting which until the study is complete. This helps researchers get the clearest possible picture of the medicine's effects.
Key takeaways
- This is an early-stage study (Phase 1) of a new medicine called IRL757.
- It's the very first time this medicine is being given to people.
- The main goals are to check the medicine's safety and how well it's tolerated in healthy adults.
- It could potentially help with apathy, a lack of motivation in certain brain conditions.
- Participants will be healthy volunteers, randomly receiving either the medicine or a dummy pill.
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. Since the main aim of this early study is to check the medicine's safety in healthy people, you won't be able to participate if you have any significant ongoing health conditions.
Because this is the first time humans are taking this medicine, the researchers are very careful about who can join. You'll have a thorough health check-up to make sure you're suitable and that taking part would be safe for you. This will include looking at your general health, any medications you take, and your medical history.
- Are you 18 years old or older?
- Are you generally in good health?
- Do you have no significant ongoing medical conditions?
- Are you available for multiple visits to a study clinic?
- Are you able to take oral medication regularly?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to participate, you will have several visits to the study clinic. These visits will involve various health checks, such as blood tests, urine tests, having your heart checked (ECG), and regular checks of your blood pressure and heart rate. You'll be given the study medicine (either IRL757 or a dummy pill) to take, and you'll be closely monitored afterward. Some visits might require you to stay at the clinic for a short period. The study team will explain exactly what's involved at each visit, how many visits there are, and the total length of your participation, including any follow-up checks after you finish taking the medicine.
Potential risks and benefits
Locations (1)
- —Sweden
Common questions
What is apathy in neurodegenerative disorders?
Apathy means experiencing a strong lack of motivation, interest, or enthusiasm for activities, often seen in people with certain brain conditions like Parkinson's or Alzheimer's disease.
What does 'first-in-human' mean?
It means this is the very first time this new medicine is being given to people, after extensive testing in laboratories and animals.
Why are healthy volunteers needed for this study?
In early studies like this, healthy volunteers help researchers safely understand how the new medicine acts in the body and what potential side effects it might have, before testing it in patients.
What is a 'placebo'?
A placebo is a 'dummy' pill that looks just like the real medicine but contains no active ingredients. It helps researchers compare the effects of the new medicine accurately.
Will I know if I'm getting the actual medicine or the placebo?
No, this study is 'double-blind,' meaning neither you nor the study team will know if you're taking the active medicine or the placebo until the study is over. This ensures fair results.
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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