Study to Learn How Safe EV25 is and the Amount of EV25 in the Body Over a Period of Time, When Taken [CCI] as a Dry Powder via the Nose by Adult Healthy People
This early-stage study is investigating a new medicine called EV25, designed to be taken as a dry powder through the nose. The main goals are to carefully check how safe EV25 is for people and to understand how the body processes it – specifically, how much of the medicine gets into the body and for how long. This particular study is for healthy adults, meaning people who do not have any major health issues. It's important to remember this is an early part of drug development, sometimes called a 'Phase I' study. The information gathered from healthy volunteers helps scientists learn more about EV25 before it can be tested in people who are actually ill with conditions like the flu.
At a glance
What is this study about?
Imagine scientists are trying to build a new type of shield against the flu virus. Before they can give this shield to people who are sick, they need to make sure the shield itself is safe and that the body can handle it well. That's what this study, looking at a medicine called EV25, is all about.
EV25 is a new medicine that's designed to be taken as a dry powder, right into your nose. This study is one of the very first times it will be given to people. The main aims are to carefully check if EV25 is safe and to track how the body uses it. This involves understanding how much of the medicine gets into your system and how long it stays there. This information is really important because it helps researchers work out the right dose and make sure it's as safe as possible for future studies.
This early research is a vital step in developing new medicines. By studying healthy adults first, scientists can learn a lot about EV25 without the additional complexities of someone already being unwell. This foundational knowledge then guides future studies that could eventually lead to new ways to treat or prevent illnesses like the flu, making a difference to public health in the long run.
Key takeaways
- This study is testing a new nasal powder medicine called EV25 for safety.
- It's an early-stage study (Phase I) for healthy adults aged 18 and over.
- The main goal is to understand how safe EV25 is and how the body handles it.
- Participants help advance research into potential new flu treatments.
- You would be closely monitored by medical staff if you take part.
Who may be eligible?
To be able to take part in this study, you need to be an adult, aged 18 years or older – there's no upper age limit. The study is open to both men and women.
Crucially, you must be a generally healthy person. This means you shouldn't have any major ongoing health problems that might affect how your body responds to the new medicine or how safe it would be for you to take part. The research team will do medical checks to make sure you fit this description.
Because this is an early test of a new medicine, they are looking for people who are in good health. This helps them understand how the medicine works in a typical, healthy body before trying it on people who are unwell.
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 in good health, without major ongoing medical conditions?
- Are you comfortable taking a new medicine as a dry powder through your nose?
- Are you available for multiple check-ups and potentially clinic visits?
What does participation involve?
If you decide to take part in this study, you would first have a screening visit. This is where the study team will carry out medical checks to make sure you are healthy and meet all the study requirements. If you're suitable, you would then attend a number of study visits. These visits would likely involve taking the EV25 medicine as a dry powder through your nose, having blood samples taken, and perhaps other simple tests like checking your heart rate or blood pressure. The research team would closely monitor you for any side effects.
There might be a period of time where you stay at the clinic for a short while after taking the medicine, or you might attend regular follow-up appointments. The exact number of visits, tests, and the total length of your involvement would be explained in detail by the study team before you decide to join. It's important to ask about all these details.
Potential risks and benefits
Locations (1)
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Common questions
What is EV25?
EV25 is a new medicine being developed, and in this study, it's being tested as a dry powder taken through the nose.
Why is this study only for healthy people?
This is an early study (Phase I) to check the safety of EV25 and how it works in the body before testing it in people who are sick.
Will I get the flu in this study?
No, this study is not about making you sick with the flu. It's about testing a new medicine in healthy people.
What is a 'dry powder via the nose'?
It means the medicine is in a powder form and you would breathe it in through your nose, similar to some nasal sprays, but without liquid.
Will I be paid to take part?
The study team will be able to tell you if there is any payment for your time and travel expenses if you qualify and take 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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