Study to look at the safety, tolerability, and how the body processes the study medicine WAL0623 after single or repeated doses, with or without food, in healthy volunteers
This early-stage study is testing a new medicine called WAL0623 for the first time in people. We're looking for healthy volunteers aged 18 and over to help us. The main goal is to find out if the medicine is safe and if healthy people can tolerate it well. We also want to understand how the body takes in, uses, and gets rid of WAL0623. To do this, we'll try different amounts of the medicine, both as a single dose and over a longer period. We'll also see if eating a meal affects how the medicine works. This information is key to understanding if WAL0623 could be a helpful treatment for kidney diseases in the future.
At a glance
What is this study about?
This research study is about a new medicine called WAL0623. When a new medicine is developed, it must go through several stages of testing to make sure it's safe and effective before it can be offered to patients. This study is one of the very first steps in that process – it's called a 'Phase I' study. This means we are testing WAL0623 for the very first time in people. Because we are looking at a new medicine, we start by testing it in healthy volunteers rather than people who are unwell. This helps us understand the basic effects of the medicine on the body without other health conditions making things complicated.
The main aim of this study is simple: we want to understand if WAL0623 is safe for people to take and how well their bodies cope with it. We'll be looking closely for any side effects and how healthy people feel after taking the medicine. We'll also be studying how the body handles WAL0623 – how much of it gets absorbed, how long it stays in the body, and how it's eventually removed. This helps us work out the right doses for future studies.
We will be testing different amounts of WAL0623, sometimes as a single dose and sometimes as repeated doses over a short period. We'll also investigate whether taking the medicine with or without food makes a difference to how the body processes it. All the information we gather from healthy volunteers in this study is crucial. It will help doctors and researchers decide if WAL0623 can safely move on to further studies in people with kidney conditions, particularly those known as 'glomerular kidney diseases with proteinuria', where the kidneys leak too much protein.
Key takeaways
- This is a very early study of a new medicine called WAL0623.
- It's being tested for the first time in healthy adult volunteers (ages 18+).
- The main goals are to check for safety, how well people tolerate it, and how the body handles the medicine.
- Information from this study will help determine if it's safe to test in people with certain kidney diseases.
- Participation involves clinic visits, possibly overnight stays, and regular health checks.
Who may be eligible?
To take part in this study, you need to be a healthy volunteer. This means you do not have any known long-term health conditions that could affect how the medicine works or put you at extra risk. Both men and women are welcome to take part.
You must be at least 18 years old to join this study. There is no upper age limit, meaning that as long as you are healthy, people of all adult ages can be considered. The doctors and nurses running the study will check your health carefully to make sure it's safe for you to participate.
- Are you 18 years old or older?
- Do you consider yourself to be in good general health?
- Are you able to commit to several clinic visits, possibly including overnight stays?
- Are you comfortable with regular blood and urine tests?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part, you will be given the study medicine, WAL0623, either as a single dose or several doses over a short period. You will come to the clinic for several visits, including overnight stays for some parts of the study, so doctors and nurses can closely monitor you. During these visits, we will take blood and urine samples often to see how your body is processing the medicine. We will also check your general health, such as blood pressure, heart rate, and temperature, and ask you about how you are feeling. We will be looking for any changes or side effects. The total time you spend in the study, including follow-up visits, will vary depending on the specific group you are in, but the study team will explain everything fully before you agree to take part.
Potential risks and benefits
Locations (1)
- —Italy
Common questions
What does 'glomerular kidney diseases with proteinuria' mean?
These are kidney conditions where the filters in your kidneys (called glomeruli) are damaged, causing too much protein to leak into your urine. This new medicine aims to help with such conditions in the future.
Why are you testing this medicine on healthy people first?
Testing on healthy volunteers helps us understand how the medicine works in the body and if it's safe, without other illnesses making the results unclear. This is a standard first step for new medicines.
Will I get paid for taking part?
Sometimes compensation is offered for time and travel, but this varies. The study team will give you full details about this if you contact them.
How long will I be in the study if I participate?
The exact duration will depend on which part of the study you join. It could involve several visits, possibly with overnight stays. The study team will explain the full schedule.
What happens after this study?
If WAL0623 is found to be safe and well-tolerated in this study, it may move on to further studies involving people who have the kidney conditions it aims to treat.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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