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

2 1

What is this study about?

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.

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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
SGS Belgium Edegem Belgium

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
17.10.2024

Trial locations

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.

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 ID:
2024-514832-26-00
Trial Phase:
Phase I and Phase II (Integrated) – First administration to humans

Other Trials to Consider

  • Study on Immune Responses to Avian Influenza Vaccine with A/Turkey/Turkey/1/05 (H5N1)-Like Strain in Patients with Avian and Seasonal Influenza

    Recruiting

    3 1 1 1
    Investigated diseases:
    Finland
  • Study on the Effectiveness of High-Dose vs. Standard-Dose Quadrivalent Influenza Vaccine in Preventing Flu in Adults Aged 65-79 in Galicia, Spain

    Recruiting

    3 1 1 1
    Investigated diseases:
    Spain