A phase I randomized, investigator and participant-blind, adaptive, multiple-ascending dose, parallel and four-way crossover, placebo-controlled study to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, and drug interactions (with midazolam) of RO7308480 following oral administration in healthy participants.
This research is looking at a new medication called RO7308480. It's a very early-stage study, meaning we're testing it for the first time in people. We want to understand if it's safe to take, what side effects it might cause, and how much of it stays in the body over time. We're also checking if it impacts how another medicine (midazolam) works. Healthy adults are taking part, and neither they nor the doctors giving the medicine will know who is receiving the new drug and who is getting a placebo (a dummy pill). This helps us get clearer results. The aim is to gather essential information before potentially testing the drug in people with specific illnesses.
At a glance
What is this study about?
This study is an important first step in understanding a potential new medicine called RO7308480. When a new drug is developed, it goes through several stages of testing. This particular study is in the very first stage, often called 'Phase 1'. This means we are carefully introducing the medicine to healthy volunteers for the first time to primarily check its safety. We want to ensure it doesn't cause unexpected or severe problems.
Beyond safety, we're also learning how the body handles this new medicine. This includes understanding how much of it gets absorbed, how long it stays in your system, and how the body breaks it down and gets rid of it. This information, often called 'pharmacokinetics', helps us figure out the best way to give the medicine in the future. We're also looking for 'pharmacodynamics', which tells us what the drug does to the body.
Another key part of this study is checking for 'drug interactions'. We'll see if RO7308480 changes how another commonly used medicine, called midazolam, works in the body. This is crucial because many people take more than one medicine, and it's important to know if they can be taken together safely. All this information is vital for deciding whether to continue developing RO7308480 for future use in patients.
Key takeaways
- This is an early-stage (Phase 1) study for a new medicine.
- The main goals are to check safety and how the medicine works in healthy people.
- Participation involves taking the study medicine (or a dummy pill) and attending clinic visits.
- Researchers are also checking how the new medicine interacts with another common drug.
- You won't know if you're getting the active drug or a placebo.
- Your contribution could help develop future treatments.
Who may be eligible?
This study is looking for healthy adult volunteers. This means you should generally be in good health and not have any serious ongoing medical conditions, nor be taking regular medications for a chronic illness.
To be considered, you need to be at least 18 years old. There is no upper age limit specified, but overall health will be assessed. Both men and women are welcome to participate in this research.
Before you can join, the study team will ask you a series of questions about your health and may run some tests to make sure it's safe for you to take part. This is to ensure your well-being throughout the study.
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 at least 18 years old?
- Are you generally in good health?
- Are you able to attend multiple clinic visits, potentially including overnight stays?
- Are you willing to take study medicine and have blood/urine samples taken?
- Are you comfortable with not knowing if you're receiving the active drug or a placebo?
What does participation involve?
If you decide to take part, you would receive the study medicine, RO7308480, or a placebo (a dummy pill). You wouldn't know which you're getting, and neither would the doctors giving it to you – this is called 'blinding'. You would come to the study clinic for several visits, which might involve staying overnight sometimes. During these visits, the study team will take blood and urine samples, measure your heart rate and blood pressure, and ask you about how you're feeling to check for any side effects. You will also be given midazolam at certain times to test for drug interactions. The study is designed with different 'parts' and 'crossover periods', meaning you might receive the medicine in different ways or at different doses. The total duration of your involvement could vary depending on which part of the study you are in, and this would be fully explained before you agree to participate.
Potential risks and benefits
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Common questions
What does 'Phase 1' mean?
Phase 1 means this is the very first time the new medicine is being tested in people, mainly to check its safety and how the body handles it.
Will I know if I'm getting the new medicine or a dummy pill?
No, neither you nor the study team giving the medicine will know. This is called 'blinding' and helps ensure the study results are clear.
What is 'midazolam' and why am I taking it?
Midazolam is a common medicine. We're using it to see if the new drug, RO7308480, affects how other medicines work in your body.
How long will I be involved in the study?
The exact duration will depend on which part of the study you join, but it will involve multiple visits, potentially including overnight stays. This will be fully explained before you agree.
Do I have to pay to join the study?
No, you will not have to pay to participate. Any study-related care and medication will be provided by the research team.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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