Study to Learn How Safe EV25 is and the Amount of EV25 in the Body Over a Period of Time, When Given as a Single Dose to Adult Healthy People [CCI]
Influenza, commonly known as the flu, is a common viral infection that can cause high temperatures, body aches, and breathing problems. While vaccines help protect people, researchers are developing new medicines to treat and prevent the virus. This study focuses on an experimental medicine named EV25. Because EV25 is at an early stage of research, doctors need to check its safety in humans for the first time. They want to see how a single dose moves through the body over time and whether it causes any unwanted side effects. To find this out, the study is inviting healthy volunteers aged 18 and over to take part. Participants will receive one dose of EV25 and then have simple health checks, including blood tests, over a set period. This essential early research helps scientists learn if EV25 could be developed into a safe treatment for the flu.
At a glance
What is this study about?
Influenza, or the flu, affects thousands of people in the UK every winter. For most, it leads to a few days in bed with chills, fever, and fatigue. However, for older adults or people with other health conditions, it can become very serious. Although annual flu jabs are vital, scientists are constantly searching for new medicines to fight flu viruses more effectively.
This trial is studying a new potential treatment called EV25. It is a 'Phase 1' clinical study, which is the very first stage where a new medicine is given to people. The main goal is not yet to see how well it treats the flu, but rather to understand how the human body processes the medicine and to ensure that it is safe to use.
Researchers will measure what happens to EV25 from the moment it enters the body until it leaves. They will look closely at how much of the medicine enters the bloodstream and how long it stays there. This process helps doctors choose the right doses for future studies.
Taking part in early research like this helps build the foundation for future medicines. By volunteering, participants provide doctors with crucial information that could lead to new ways to protect people from serious viral illnesses in the future.
Key takeaways
- Tests the safety of an experimental flu medicine called EV25.
- Open to healthy adult volunteers aged 18 and older.
- Participants receive only a single dose of the medicine.
- Involves health checks, blood tests, and follow-up visits.
- Participation is entirely voluntary and you can leave at any time.
Who may be eligible?
This study is looking for healthy adult volunteers. To take part, you must be at least 18 years of age. Because the researchers need to study how EV25 works in an otherwise healthy body, volunteers generally should not have any long-term or serious medical conditions.
You might not be able to join if you have ongoing health problems, such as heart, kidney, or liver conditions, or an active infection. People who are pregnant, planning to become pregnant, or breastfeeding will usually be excluded to protect their health and that of their baby. You may also need to avoid taking certain prescription medicines or over-the-counter supplements during the study.
The trial team will carry out a thorough health check before you join to ensure taking part is safe for you. They will explain the full list of rules and answer any questions you have about whether the trial is a good fit.
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 aged 18 or older?
- Do you consider yourself to be in generally good health?
- Are you free from serious, long-term medical conditions?
- Are you able to attend clinic visits for regular health checks?
- If relevant, are you certain you are not currently pregnant or breastfeeding?
What does participation involve?
Taking part in this study begins with a screening appointment where the research team will check your medical history, take blood pressure and blood samples, and make sure it is safe for you to participate. If you are eligible and agree to take part, you will be given a single dose of the study medicine, EV25. After receiving the dose, you will stay under the care of the medical team for observation. In Phase 1 trials, this sometimes involves a short stay in a dedicated research unit so doctors can monitor you closely. Over the following days or weeks, you will have follow-up visits so the team can check your health, ask how you are feeling, and take further small blood samples to see how much medicine remains in your system.
Potential risks and benefits
Locations (1)
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Common questions
Will I be given the flu virus during this study?
No. You will not be exposed to the flu virus. You will only receive a dose of the study medicine, EV25, so researchers can check its safety.
Is EV25 already available from my GP?
No, EV25 is an experimental medicine. It is only available through clinical trials while doctors study how it works.
Do I have to pay to take part in this trial?
No. You will not pay for the study medicine or the clinic appointments. Clinical trials often cover reasonable travel costs as well.
Can I leave the study early if I change my mind?
Yes. Taking part is completely voluntary. You can choose to stop participating at any time, and you will still receive your normal medical care.
What happens if I feel unwell during the trial?
The research team will be on hand to monitor you, and you will have emergency contact numbers to call. A doctor is always available to assist you.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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