A First-in-Human, randomised, double blind, placebo-controlled, single ascending dose trial to evaluate safety, tolerability, and pharmacokinetics of APC148 in healthy adults.
This research is looking at a new potential medicine called APC148. This is the very first time it will be given to people, so we're starting with healthy adults. The main goals are to check if it's safe, to understand any side effects it might cause, and to see how the body uses and gets rid of it. We'll be giving different people different doses of APC148, or a dummy medicine called a placebo, without anyone knowing who gets what. This is an important initial step to see if APC148 could eventually be a new treatment for urinary tract infections (UTIs) in the future. Finding safe and effective treatments for UTIs is important for many people.
At a glance
What is this study about?
This study is a very early step in testing a new medicine called APC148. Imagine it like the first test drive of a brand new car model, but for medicine. The main reason for doing this study is to make sure the medicine is safe when given to people for the first time. We also want to understand if it causes any side effects and how it travels through the body.
At this stage, we are not trying to treat any illness. Instead, we are giving the medicine to healthy volunteers. This helps us learn about how APC148 works in general before it's given to people who are unwell. The information we gather will help scientists decide if it's safe to move forward with larger studies in people who actually have urinary tract infections (UTIs).
Urinary tract infections can be uncomfortable and sometimes serious for many people. Developing effective and safe new treatments is important. This study is a crucial foundation for that process. It's a 'double-blind' study, meaning neither you nor the study team will know if you're getting the new medicine or a dummy pill (placebo). This helps us get the most accurate results possible.
Key takeaways
- This is a first-time test of a new medicine, APC148, in healthy people.
- The main goals are to check for safety and side effects, and see how the body handles the medicine.
- Participants will receive either APC148 or a placebo, without knowing which.
- The study aims to contribute to developing new treatments for UTIs.
- You will be closely monitored by medical professionals if you take part.
- You can withdraw from the study at any time.
Who may be eligible?
To join this study, we are looking for healthy adults. You must be at least 18 years old; there is no upper age limit. Both men and women are welcome to take part.
Because this is a very first-in-human study, there will be strict health checks to make sure you are in good general health. If you have any ongoing medical conditions, are taking certain medications, or have any other health concerns, these would be discussed with the study team to see if you can safely participate. The aim is to protect your health while gathering important information about the new medicine.
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?
- Are you happy to attend multiple clinic visits?
- Are you comfortable not knowing if you receive the study medicine or a placebo?
What does participation involve?
If you decide to take part, you would receive either the new study medicine, APC148, or a placebo (a dummy pill with no active ingredient). This would be given as a single dose. You wouldn't know which one you received, and neither would the study team, to keep things fair and unbiased.
You would need to attend the study clinic for several visits. During these visits, the study team would carefully monitor your health. This would involve checks like blood tests, urine tests, measuring your heart rate and blood pressure, and asking you about any symptoms or how you are feeling. These checks are to ensure your safety and to see how the medicine is working in your body.
After receiving the dose, there would be follow-up appointments scheduled over a period of time to continue monitoring your health and collect more information. The exact number of visits and the total duration would be explained in detail by the study team.
Potential risks and benefits
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Common questions
What is a 'first-in-human' study?
It means this is the very first time the new medicine, APC148, is being given to people. It's an early stage to check its safety and how it works in the body.
What is a 'placebo'?
A placebo is a dummy pill or treatment that looks exactly like the study medicine but contains no active ingredient. It helps us compare the effects of the real medicine accurately.
Will I know if I'm getting the actual medicine or the placebo?
No, this is a 'double-blind' study, meaning neither you nor the study team will know who receives the study medicine and who receives the placebo until the study is over.
Why use healthy adults instead of people with UTIs?
Starting with healthy adults helps us understand the basic safety and how the medicine behaves in the body before giving it to people who are already unwell. This is a very common and safe way to begin testing new medicines.
What are Urinary Tract Infections (UTIs)?
UTIs are common infections that can affect any part of the urinary system, including the bladder, kidneys, and urethra. They can cause pain, burning, and frequent urges to urinate.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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