A Phase 2a Randomized, Double-blind, Placebo-controlled Trial with Open-label Dose-finding Cohorts to Evaluate the Efficacy and Safety of CR9114 Monoclonal Antibody Administered as Intranasal Doses in Healthy Adult Participants who are Challenged with a Live, Wild-type Influenza Type A Virus (A/Belgium/4217/2015 H3N2)
This study is looking at a new nose spray medicine, CR9114, to see how well it works and how safe it is for treating the flu. Healthy adult volunteers will be given a specific type of flu virus. After this, they will either receive the CR9114 nose spray, a different dose of it, or a dummy spray (placebo). Researchers will then carefully watch for flu symptoms, how severe they are, and how long they last. They will also collect information on any side effects experienced. The aim is to understand if CR9114 can help people recover from the flu more quickly and with fewer problems.
At a glance
What is this study about?
This study is a medical research project focused on a new medicine called CR9114, which is given as a nose spray. Its main goal is to find out if CR9114 can be an effective and safe way to treat the flu, specifically a common type known as H3N2 influenza. This kind of study is called a Phase 2 trial, which means it's an early step in testing new medicines in people, to see if they are promising enough to continue with larger studies.
To do this, healthy adult volunteers will first be given a controlled amount of the flu virus. This allows researchers to consistently study how the new treatment affects the illness. After being exposed to the flu virus, participants will be randomly chosen to receive either the CR9114 nose spray (at different dose levels that researchers are exploring), or a dummy spray that looks exactly the same but contains no medicine, called a placebo. This comparison helps researchers understand if any improvements are due to the CR9114 or simply the body naturally recovering.
The research team will closely monitor participants for flu symptoms, how quickly they appear, how severe they are, and how long they last. They will also look for any unwanted side effects from the treatment. By carefully collecting and comparing all this information, scientists hope to learn if CR9114 can help people get better from the flu faster, make their symptoms milder, and do so without causing serious problems. This kind of research is really important for developing new ways to fight the flu and protect public health.
Key takeaways
- This study tests a new nose spray called CR9114 for flu.
- Healthy adults will be given a flu virus and then the treatment or a dummy spray.
- The aim is to see if CR9114 helps reduce flu symptoms and how safe it is.
- Participation involves staying at a research centre for monitoring.
- Your health and safety will be carefully watched throughout the study.
Who may be eligible?
To be able to take part in this study, you need to be an adult over the age of 18. There isn't an upper age limit mentioned, so older adults could potentially join too.
Both men and women are welcome to participate. The study is specifically looking for people who are generally healthy before they join.
Because this study involves giving you a flu virus, there will be strict health checks to make sure it's safe for you to take part. Things like having certain long-term health conditions or taking certain medications might mean you can't join. The study team will discuss all of this with you in detail.
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?
- Do you understand that you will be given a flu virus?
- Are you able to commit to the study's visits and requirements?
What does participation involve?
If you decide to take part, you'll be asked to come to a research centre for an initial check-up to make sure you're suitable. Once you're confirmed for the study, you'll be given a specific type of flu virus. After this, you'll start receiving either the CR9114 nose spray or a dummy spray, as instructed by the study team.
You'll stay at the research centre for a period, where nurses and doctors will closely monitor your health. They’ll regularly check your symptoms, take samples (like nose swabs) to see how the flu virus is progressing, and ask you to fill out questionnaires about how you're feeling. This will help them measure the effectiveness of the treatment and track any potential side effects.
The exact number of visits, tests, and the total time you'll spend in the study will be fully explained to you before you agree to participate. There will also be follow-up checks after you leave the centre to ensure your recovery is going well. The total duration of your active involvement in the study, including follow-up, will be clearly outlined.
Potential risks and benefits
Locations (1)
- —UnverifiedBelgium
Common questions
What is CR9114?
CR9114 is a new medicine being tested as a nose spray for treating the flu.
Will I definitely get the flu if I join this study?
Yes, a flu virus will be given to participants in a controlled way to study the medicine's effects.
What does 'placebo' mean?
A placebo is a dummy treatment, like a nose spray that looks real but doesn't contain any medicine. It helps researchers compare the effects of the actual drug.
How long will I need to stay at the clinic?
The study team will explain the exact time you'll need to stay at the clinic, as it can vary, but typically it involves an inpatient stay.
Will I know if I'm getting the real medicine or the placebo?
No, in this type of 'double-blind' study, neither you nor the study doctors will know who is receiving the medicine or the placebo until after the study is over. This makes the results more reliable.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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