Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study on the Effectiveness and Safety of CR9114 for Preventing Influenza in Healthy Adults

InvestigationalNo placebo
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 effects of a new treatment for the influenza virus, commonly known as the flu. The treatment being tested is a monoclonal antibody called CR9114, which is administered through the nose using a nasal spray. The study also involves a version of the flu virus known as Wild-Type A Influenza Virus A/Belgium/4217/2015 (H3N2) to see how well the treatment works in preventing or reducing flu symptoms.

The purpose of the study is to evaluate how effective and safe the CR9114 treatment is when given to healthy adults who are exposed to the flu virus. Participants will receive either the CR9114 treatment, a placebo, or the flu virus through a nasal spray. The study will monitor participants for a short period to observe any changes in flu symptoms and to ensure the treatment is safe.

Throughout the study, participants will be closely observed to track the occurrence and severity of any flu symptoms. The study aims to determine if the CR9114 treatment can reduce the incidence of flu symptoms and how well participants tolerate the treatment. This research is important for developing new ways to prevent and treat the flu in the future.

The research process

The trial runs in 4 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, you will be randomly assigned to receive either the CR9114 nasal spray, the wild-type A influenza virus nasal spray, or a placebo nasal solution. This process is double-blind, meaning neither you nor the researchers will know which treatment you are receiving to ensure unbiased results.

  2. Step 2

    Administration of nasal spray

    You will receive the assigned nasal spray through intranasal use. This means the solution will be administered directly into your nose. The exact dosage and frequency will be determined by the study protocol, and you will be informed of these details during the trial.

  3. Step 3

    Monitoring and assessments

    Throughout the trial, your health will be closely monitored. This includes regular check-ups and assessments to evaluate the efficacy and safety of the treatment. You will be asked to report any symptoms or side effects you experience.

    You will also undergo tests to measure the presence of the influenza virus in your body. This involves taking samples from your nose to check for viral load using a method called qRT-PCR, which is a type of test that detects the virus's genetic material.

  4. Step 4

    Completion of the trial

    The trial will conclude after a specified period, which is estimated to be around 11 days from the start of the treatment. At the end of the trial, you will have a final assessment to ensure your well-being and to gather any last data needed for the study.

Who can join the trial?

4 criteria

  • Must be a male or female between 18 and 55 years old.
  • Must have a Body Mass Index (BMI) between 19.0 and 30.0 kg/m² and weigh at least 50.0 kg. BMI is a measure of body fat based on height and weight.
  • Must be considered healthy by the study doctor, based on medical history, physical exam, vital signs, heart test (ECG), and lab tests.
  • Must have a negative test for hepatitis B and C, and HIV. This means no signs of these infections in the blood.

Who cannot join the trial?

10 criteria

  • Patients who are not within the age range specified for the study.
  • Patients who have a history of severe allergic reactions to any component of the study medication.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a medical condition that the study doctors believe would make it unsafe for them to participate.
  • Patients who are pregnant or breastfeeding.
  • Patients who have received another investigational drug within a certain period before the study starts.
  • Patients who have a history of drug or alcohol abuse that could interfere with their participation in the study.
  • Patients who have a known infection with the **HIV** virus, **Hepatitis B**, or **Hepatitis C**.
  • Patients who have received a live vaccine within a certain period before the study starts.
  • Patients who have a history of certain chronic diseases that are not well controlled.
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

CR9114 is a monoclonal antibody being tested in this clinical trial. Monoclonal antibodies are special proteins made in a lab that can attach to specific targets in the body, like viruses. In this study, CR9114 is given as a nasal spray to healthy adults. The goal is to see if it can help reduce the chances of getting sick when exposed to a specific type of flu virus, known as Influenza Type A. The study also aims to check if CR9114 is safe and if people can tolerate it well without significant side effects.

What is already known about the treatment

CR9114 – CR9114 is a monoclonal antibody administered through the nose, designed to help protect against the influenza virus, specifically targeting the H3N2 strain. It is currently being studied in clinical trials to assess its effectiveness and safety in reducing flu symptoms in healthy adults exposed to the virus. The main goal of this medication is to prevent the flu by blocking the virus from infecting cells. CR9114 belongs to a class of drugs known as monoclonal antibodies, which are lab-made proteins that mimic the immune system's ability to fight off harmful pathogens.

Investigated diseases

Influenza – Influenza, commonly known as the flu, is a contagious respiratory illness caused by influenza viruses. It primarily affects the nose, throat, and sometimes the lungs. The disease typically begins suddenly and can cause symptoms such as fever, cough, sore throat, runny or stuffy nose, muscle or body aches, headaches, and fatigue. In some cases, it can lead to more severe complications, especially in young children, elderly adults, and individuals with certain health conditions. The virus spreads through droplets when an infected person coughs, sneezes, or talks. The progression of the disease can vary, with symptoms usually appearing one to four days after exposure and lasting for about a week, although some symptoms like cough and fatigue may persist longer.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-505020-57-00Protocol codeF21-CLD-201Estimated enrolment140 patientsSponsorLeyden Laboratories B.V.

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.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).