Ongoing, recruitingPhase I and Phase II (Integrated)- First administration to humansInterventional

A Phase I/IIa, Randomized, Double-Blind, Placebo-Controlled, Single Dose and Single-Dose Challenge Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of Intranasal EV25 in Healthy Volunteers and in Influenza Challenge Participants

Doctors are running a study to test a new nasal spray called EV25. They want to see if it's safe, how the body handles it, and if it can help protect against or treat the flu. The study has two main parts. First, healthy volunteers will try the spray to check for any side effects and understand how it works in the body. In the second part, some participants will be given the flu virus on purpose to see if the nasal spray helps them. Another group will receive a dummy spray (placebo) for comparison. The goal is to find new ways to fight the flu.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- First administration to humans

Sponsor

Eradivir Inc.

Enrolment target

122

Start

07 Nov 2024

Virus Influenza

What is this study about?

This study is about understanding a new investigational nasal spray called EV25. The main purpose is to find out if it's safe for people to use and if it can help protect against or treat the flu. Many of us get the flu, and finding new effective ways to fight it is really important.

This study is happening in two main stages. The first stage, known as Phase I, focuses on safety. Healthy volunteers will receive either the EV25 nasal spray or a dummy spray (a placebo). Doctors will closely check for any side effects, how the body reacts to the spray, and how much of the spray stays in the body over time. This helps them understand if the spray is generally safe for people to use.

The second stage, known as Phase IIa, looks at how well the spray works. In this part, participants will intentionally be exposed to a specific flu virus. Researchers will then see if the EV25 nasal spray can help prevent them from getting sick, or make their flu symptoms less severe. This side-by-side testing of the actual spray against a placebo helps doctors determine if EV25 is truly effective against the flu virus.

Key takeaways

This study is testing a new nasal spray, EV25, for safety and effectiveness against the flu.
It involves healthy people and some who will be intentionally exposed to the flu virus.
Participants will receive either the active spray or a dummy spray (placebo).
Close medical monitoring is provided throughout the study.
The goal is to find new ways to prevent or treat influenza (the flu).

Who may be eligible?

To be considered for this study, you need to be an adult, at least 18 years old. Both men and women can take part. There are other specific health requirements that you would need to meet.

For example, you would need to be generally healthy and not have any pre-existing medical conditions that might interfere with the study or put your health at risk. You would also need to meet certain criteria related to your health history and current medications.

It's important to remember that the research team will carefully review your health information to make sure this study is suitable and safe for you. They will explain everything in detail if you are interested in participating.

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?
Are you comfortable potentially receiving a dummy spray?
Are you willing to attend multiple clinic visits?
Are you willing to be exposed to the flu virus if you are in that part of the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you might receive either the EV25 nasal spray or a placebo (a dummy spray that looks and feels the same but contains no medicine). All treatments are given through the nose.

Initially, for the safety part of the study, you'll have several check-ups where doctors will monitor your health very closely. They'll do things like blood tests, check your heart rhythm with an ECG, take your blood pressure, and perform general health checks. They will also look at your nose to see how it's reacting to the spray.

If you're part of the second stage, you'll be exposed to a flu virus, and doctors will closely watch for any flu symptoms and how your body responds to the spray. You will have regular visits to the clinic, and the total length of your participation, including follow-up, will be explained fully by the study team.

Potential risks and benefits

Participating in a study like this could offer potential benefits, such as contributing to scientific knowledge that might lead to new flu treatments. You would also receive close medical attention throughout the study. However, there are potential risks, including side effects from the nasal spray, or experiencing flu-like symptoms if you are exposed to the virus. You will be fully informed of all known and potential risks before you decide to join. Remember, taking part is completely voluntary, and you have the right to withdraw from the study at any time without giving a reason.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Belgium

Common questions

What is EV25?

EV25 is an experimental nasal spray that researchers are testing to see if it can help prevent or treat the flu.

Will I definitely get the real nasal spray?

No, this is a 'double-blind' study, meaning some participants will receive the EV25 spray, and others will receive a dummy spray (placebo). Neither you nor the study team will know which you are receiving.

What does being 'challenged' with a flu virus mean?

It means that in one part of the study, some participants will be deliberately given the flu virus under controlled medical supervision to see how the nasal spray works against it.

Will this study cure my flu?

This study is for research purposes. Its aim is to investigate the potential of EV25 to help with the flu, not to provide a direct cure for existing flu in participants.

How long will I be in the study?

The full length of your participation, including any follow-up appointments, will be clearly explained by the study team before you decide to join.