In short
Clinical trials investigating "INFLUENZA A VIRUS A/BELGIUM/4217/2015 (H3N2)" are studying how this influenza virus is used in research settings. The trial data focus on safety, tolerability, body levels over time, and effects on viral measures in healthy adults, including people exposed to influenza H3N2.
Key points
- Clinical trials investigating "INFLUENZA A VIRUS A/BELGIUM/4217/2015 (H3N2)" focus on a single early-stage study in healthy adults. The study is Phase 1/2 and looks at safety, tolerability, and how EV25 behaves in the body after a single intranasal dose. It also studies healthy participants exposed to influenza H3N2 to see whether EV25 changes viral AUC, meaning the total virus measured over time. Main checks include side effects, lab tests, ECG findings, vital signs, physical exams, and nasal exam findings. The trial is completed and enrolled 122 people.
Trial overview
The clinical trial data describe one interventional study, which means researchers gave a study treatment and then measured what happened. The study looked at EV25 given through the nose, and it also included a setting where participants were exposed to INFLUENZA A VIRUS A/BELGIUM/4217/2015 (H3N2).
The study was completed and enrolled 122 people. It was designed to learn about safety, tolerability, and the amount of EV25 in the body over time.
Who participated
The study included healthy adult people. Part I studied healthy participants taking a single nasal dose, and Part II studied healthy participants exposed to influenza H3N2.
This means the trial was not focused on people with severe illness or long-term disease, but on healthy volunteers in an early research setting.
What was studied
The study tested EV25 given by the intranasal route, which means through the nose. Researchers compared EV25 with a placebo nasal spray in the influenza-exposed part of the trial.
A placebo is a look-alike treatment that does not contain the active study drug, and it helps researchers compare results fairly. The study also included wild-type A Influenza Virus A/Belgium/4217/2015 (H3N2), which is the natural virus form used in the research setting.
Main endpoints
The primary safety measures in Part I were adverse events, laboratory safety assessments, 12-lead ECG findings, vital signs, physical examination findings, and intranasal administration site examination findings. These measures help researchers see whether the study treatment caused any safety concerns.
The study also aimed to measure the PK profile, which shows how much EV25 is in the body over time after a single dose. In Part II, researchers looked at the effect of single doses of EV25 on viral AUC compared with placebo in healthy participants who had positive predose values.
Viral AUC means the total amount of virus measured over time, so it gives a summary of how the virus changed during the study.
Trial phase and status
The trial was in Phase 1/2, an early stage that usually starts with safety and then begins to explore effects in the body. The study status was completed.
The trial was single-dose, meaning participants received one dose during the study. The brief summary shows that researchers separated the work into two parts: one for healthy participants and one for healthy participants exposed to influenza H3N2.
Patient-friendly terms
- Healthy participants: people without the illness being studied, used to help researchers understand safety and early effects.
- Vital signs: basic body checks like pulse and blood pressure.
- Physical examination: a doctor’s body check to look for health problems.
- Intranasal administration: treatment given through the nose.
- Laboratory safety assessments: lab tests used to watch for problems in the body.
- ECG: a heart test that records electrical signals from the heart.