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

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What is this study about?

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.

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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
SGS Belgium	Edegem	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	06.07.2023

Trial locations

Investigated drugs:

WILD-TYPE A INFLUENZA VIRUS A/BELGIUM/4217/2015 (H3N2)

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.

Investigated diseases:

Influenza

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 ID:

2023-505020-57-00

Protocol code:

F21-CLD-201

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?