Phase I, first-in-man, randomised, placebo-controlled, single dose escalation study to investigate the effects of LPH-5 on safety, tolerability, pharmacokinetic and pharmacodynamic parameters in healthy participants
This is a very early study looking at a new medicine called LPH-5, which could potentially help people with depression. It's the first time this medicine is being given to humans. We want to see if it's safe to use and how well people tolerate it. Researchers will also check how the body handles LPH-5, like how much gets into the blood and how long it stays there. Participants will be healthy adults, and some will receive the medicine while others get a dummy pill (placebo) to help compare the effects. This helps us understand if LPH-5 might be a good option for treating depression in the future.
At a glance
What is this study about?
Imagine you're trying a new recipe for the very first time. You wouldn't make a huge batch straight away, right? You'd probably try a small amount to see if it tastes good and if it's safe to eat. That's a bit like what this study is doing with a new medicine called LPH-5.
This study is for a new medicine that doctors hope could help people who feel very low or sad, a condition known as depression. Depression is a common illness that can make everyday life very difficult. Finding new and better ways to treat it is really important.
Because this is the very first time LPH-5 is being given to people, the main goal is to check its safety. Researchers want to make sure it doesn't cause serious side effects. They will also look at how the body handles the medicine – how much is absorbed, how it moves through your system, and how the body gets rid of it. This helps them understand the right dose to use in future studies.
Key takeaways
- This is a first test in humans for a new medicine called LPH-5 for depression.
- The main goal is to check if LPH-5 is safe and how the body handles it.
- Healthy adults (18 years and older) are needed for this study.
- You might receive the new medicine or a dummy pill (placebo).
- Your participation could help develop future depression treatments, though no direct benefit to you is expected.
- You can stop participating at any time.
Who may be eligible?
To be part of this study, you need to be a healthy adult, aged 18 years or older. This means you generally don't have any major ongoing health problems.
Because this is the first time the medicine is being tested in people, the study needs participants who are in good health. This helps the researchers clearly see how the new medicine affects the body without other health conditions getting in the way.
More detailed checks will happen if you show an interest, to make sure the study is right and safe for you. For example, they'll check you don't have certain medical conditions or take medicines that might react with LPH-5.
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?
- Are you generally healthy with no major ongoing medical conditions?
- Are you happy to potentially receive either the study medicine or a placebo?
- Are you able to attend several appointments at a study clinic and for follow-up?
- Do you understand that this is a very early-stage study with no guaranteed benefits for you personally?
What does participation involve?
If you decide to take part, you would first have a health check-up to make sure you're suitable for the study. If you are, you would be given a single dose of either the new medicine, LPH-5, or a placebo (a dummy pill with no medicine). You wouldn't know which one you received. You would stay at the study clinic for a period of time so medical staff can carefully monitor you for any side effects and take blood samples.
There would be several follow-up visits or phone calls over a few weeks to continue checking on your health and collect more information. The exact number of visits, tests, and the total time you would be involved will be explained in detail before you agree to take part.
Potential risks and benefits
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Common questions
What is LPH-5?
LPH-5 is a new medicine that researchers hope might help people who have depression. This study is one of the very first times it's being tested in humans.
Why is this study only for healthy people?
Because this is the first time LPH-5 is being given to humans, it's important to study it in healthy volunteers. This helps researchers clearly see how the medicine works and if it has side effects, without other health conditions making things more complicated.
What does 'first-in-man' mean?
It means this is the very first time this particular new medicine has been given to people, rather than just tested in laboratories or animals.
Will I get the actual medicine or a dummy pill?
You will be given either the new medicine (LPH-5) or a dummy pill called a placebo. The study is 'randomised', meaning you're assigned to one or the other by chance, and you won't know which one you're taking.
Do I have to pay to join the study?
No, you don't have to pay to join. In fact, you may receive some payment for your time and inconvenience for taking part.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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