Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study on the Safety and Effects of Intranasal EV25 in Healthy Adults with and without Influenza Virus Exposure

Investigational
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the safety and effects of a new treatment called EV25, which is administered as a nasal spray. The study is particularly interested in how EV25 works in healthy adults and in those who are exposed to the Influenza A Virus, specifically the H3N2 strain. The trial will compare the effects of EV25 to a placebo, which is a substance with no active drug, to understand its impact better.

The purpose of the study is to assess how safe and tolerable a single dose of EV25 is when given through the nose. Participants will receive either the EV25 nasal spray or a placebo. The study will also look at how much of the drug is present in the body over time and its effects on the body, especially in those who have been exposed to the Influenza A Virus. The study will be conducted in two parts: the first part involves healthy participants, and the second part involves participants who are exposed to the virus.

Participants will be monitored for any side effects and changes in their health through various assessments, including laboratory tests and physical examinations. The study aims to gather information on the safety and potential benefits of EV25 in preventing or reducing the effects of the Influenza A Virus. This research is important for developing new treatments that could help manage or prevent flu infections in the future.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant will have already signed an informed consent form. This indicates understanding of the study's purpose and procedures, and willingness to participate.

  2. Step 2

    Initial assessment

    Participants will undergo an initial assessment to ensure they meet the study's criteria. This includes confirming that female participants are not pregnant or breastfeeding and agree not to donate eggs during the study period.

  3. Step 3

    Part I: single dose administration

    Participants will receive a single dose of the study medication, EV25, administered as a nasal spray. This is done to assess the safety and tolerability of the medication in healthy individuals.

  4. Step 4

    Monitoring and assessments

    After receiving the dose, participants will be monitored for any adverse effects and undergo various assessments. These include laboratory tests, heart monitoring through a 12-lead ECG, checking vital signs, and physical examinations.

  5. Step 5

    Part II: exposure to influenza

    In this part, participants will be exposed to the influenza virus to further assess the safety and effects of the EV25 nasal spray. The goal is to understand how the medication affects the virus in the body.

  6. Step 6

    Final assessments

    Participants will undergo final assessments to evaluate the overall safety and effectiveness of the medication. This includes reviewing any adverse effects and the results of all tests conducted during the study.

Who can join the trial?

5 criteria

  • The participant must sign an Informed Consent Form (ICF) voluntarily before any study-related procedure is performed. This means they understand the purpose of the study and agree to participate.
  • Female participants must not be pregnant or breastfeeding, and they should not plan to become pregnant or start breastfeeding during the study period, which lasts from the screening to 30 days after receiving the study treatment.
  • Female participants must agree not to donate eggs from the time of screening to 30 days after receiving the study treatment.
  • The study is open to both male and female participants.
  • The study includes participants who are considered a vulnerable population, which means they might need special protection or consideration.

Who cannot join the trial?

10 criteria

  • Participants who are not in the age range of 18 to 65 years old.
  • Individuals who are not healthy. This means anyone with ongoing medical conditions or illnesses.
  • People who have a known allergy or sensitivity to the study medication or its ingredients.
  • Women who are pregnant or breastfeeding.
  • Individuals who have participated in another clinical trial within the last 30 days.
  • People who have a history of drug or alcohol abuse within the past year.
  • Individuals with a history of respiratory diseases, which affect the lungs and breathing.
  • Anyone who has received a flu vaccine within the last 6 months.
  • Participants who have a history of severe allergic reactions, known as anaphylaxis.
  • Individuals who are currently taking medications that might interfere with the study.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

EV25 is a medication being tested in this clinical trial. It is given as a spray into the nose, which is known as intranasal administration. The main goal of this study is to see if EV25 is safe and well-tolerated when given to healthy people. The trial also aims to understand how the body processes EV25 after it is administered. In the second part of the study, researchers are looking at how EV25 affects people who have been exposed to a specific type of flu virus, called influenza H3N2. They want to see if EV25 can help reduce the amount of virus in the body compared to those who do not receive the medication. This study is important to determine if EV25 could be a potential treatment for flu infections in the future.

What is already known about the treatment

EV25 – EV25 is administered as a nasal spray, which means it is applied directly into the nose. Currently, it is being studied in clinical trials to understand its safety and effectiveness, particularly in relation to the flu virus. The main use of EV25 is to help manage and potentially reduce the effects of the influenza virus, specifically the H3N2 strain. At the molecular level, EV25 works by interacting with the virus in the nasal passages, potentially preventing it from spreading and causing illness. It is classified as an antiviral medication, which means it is designed to fight viruses.

Investigated diseases

Influenza – Influenza, commonly known as the flu, is a viral infection that primarily affects the respiratory system, including the nose, throat, and lungs. It is caused by influenza viruses, which are classified into types A, B, and C, with type A being the most common and often responsible for seasonal outbreaks. The disease typically begins suddenly with symptoms such as fever, chills, muscle aches, cough, congestion, runny nose, headaches, and fatigue. As the infection progresses, symptoms can become more severe, leading to complications such as pneumonia, especially in vulnerable populations like the elderly and those with weakened immune systems. Influenza is highly contagious and spreads through respiratory droplets when an infected person coughs, sneezes, or talks. The course of the illness usually lasts about one to two weeks, with most people recovering without requiring medical intervention.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2024-514832-26-00Estimated enrolment122 patientsSponsorEradivir Inc.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.