CompletedPhase IIInterventional

Evaluate the efficacy, safety and dose-response of S-337395

This research is looking at a new experimental medicine called S-337395 to see if it can help people who get sick with Respiratory Syncytial Virus (RSV). RSV can cause serious breathing problems, especially in babies, older people, and those with certain health conditions. Healthy people aged 18 to 55 will be invited to take part. After some checks, they will be given the RSV virus in a special quarantine facility. Then, they will randomly receive either the new study drug or a 'placebo' (a dummy drug). Doctors will closely watch how they respond to RSV and the treatment. The main goals are to check if the new drug is safe, how well it works, and what dose might be best. The study is funded by Shionogi B.V. and will happen in London.

At a glance

Status

Completed

Phase

Phase II

Sponsor

Shionogi BV

Enrolment target

114

Start

03 Apr 2024

Estimated completion

04 Sep 2024

Respiratory Syncytial Virus (RSV)

What is this study about?

This study is testing a new medicine called S-337395, which doctors hope might help treat Respiratory Syncytial Virus, or RSV. RSV is a common germ that can cause cold-like symptoms, but it can also lead to more serious breathing illnesses like bronchitis or pneumonia. These serious conditions are particularly risky for very young children, older adults (especially those over 65), and people with existing heart, lung problems, or weaker immune systems.

The study aims to find out if S-337395 is effective against RSV and if it's safe for people to take. To do this, healthy volunteers will be carefully given the RSV virus in a controlled setting. This allows researchers to see how the new medicine helps, or doesn't help, the body fight off the infection. Some participants will receive S-337395, while others will get a 'placebo' — a dummy medicine that looks the same but has no active ingredients. This helps researchers compare the effects accurately.

Researchers will be looking closely at how participants react to the virus and the medicine. They want to understand if the new drug can reduce the symptoms or length of RSV illness, and if there are any side effects. This kind of research is very important for developing new treatments that could one day help protect vulnerable people from the more serious effects of RSV.

Key takeaways

This study is testing a new medicine (S-337395) for RSV.
Healthy volunteers (18-55 years old) are needed.
Participants will be given the RSV virus in a controlled setting.
You will receive either the study drug or a dummy drug (placebo).
Expect a 16-day stay in a quarantine facility.
The total study commitment is about 4 months.

Who may be eligible?

To be considered for this study, you need to be a healthy adult aged between 18 and 55 years old. You should have a healthy body weight for your height, and generally be in good health without any major medical problems or unusual test results that a doctor would be concerned about.

Importantly, you must also be someone who is likely to catch the RSV virus easily. This means you wouldn't have a strong natural protection against it already. Before joining, a doctor will check your medical history and do some examinations to make sure you meet all these health requirements.

There might be other reasons why this study isn't suitable for you, even if you meet these main points. For instance, sometimes certain medications you're taking or other health conditions discovered during the initial checks could mean you cannot take part. The study team will explain everything fully.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 55 years old?
Are you generally healthy with no major medical conditions?
Do you have a healthy weight for your height (BMI between 18 and 35)?
Are you likely to be susceptible to the RSV virus (not have strong existing immunity)?
Are you able to stay in a quarantine facility for about 16 days?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will last about four months in total, from your first check-up to your final visit. It involves three main stages:

First, there's the **Screening Phase**. This happens 2 to 3 months before the main study. You'll have medical checks to make sure you're healthy enough and meet all the study requirements. If you qualify and agree to participate, you'll sign a consent form.

Next is the **Quarantine Phase**. You'll stay in a special facility for about 16 days. On 'Day 0' of your stay, you will be given the RSV virus. You'll then receive either the study drug, S-337395, or a placebo (dummy drug). Medical staff will closely monitor your health, symptoms, and any side effects throughout this time. You'll usually leave around day 13, but might need to stay a bit longer if the doctors think it's necessary.

Finally, the **Follow-up Phase** takes place about 28 days after you were given the virus. You'll have a last check-up, where doctors will review your health, symptoms, and make sure everything is okay.

Potential risks and benefits

There are no direct health benefits for you personally from taking part in this study; it won't improve your existing health. However, you will get a general health check during the screening, and you might develop some immunity to RSV after being exposed to the virus. There's always a chance of unexpected risks with any new medicine or medical procedure. These risks, including those related to the study drug or the virus itself, will be fully explained in a detailed consent form. While you are in the quarantine facility, medical staff will be on hand 24/7 to closely monitor your condition and provide any necessary medical help. You are free to withdraw from the study at any time without giving a reason.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

hVIVO Services Limited
City only
London, England
hVIVO Services Limited
City only
London, England

Common questions

What is RSV?

RSV stands for Respiratory Syncytial Virus. It's a common virus that usually causes mild, cold-like symptoms, but it can be more serious for babies, older adults, or people with certain health conditions, leading to breathing problems like bronchitis or pneumonia.

What is S-337395?

S-337395 is a new experimental medicine that researchers are testing to see if it can help treat people infected with the RSV virus.

Will I definitely get the active drug?

No, not everyone will receive the active drug. Some participants will be randomly given a 'placebo', which is a dummy medicine that looks like S-337395 but doesn't contain any active ingredients.

How long will I have to stay in quarantine?

You will need to stay in a special quarantine facility for about 16 days. You'll typically leave around Day 13, but might need to stay a bit longer if the doctors feel it's necessary for your health.

Who is paying for this study?

The study is being funded by Shionogi B.V., a company based in the Netherlands.

How to find out more

Madhuri Patel

m.patel@hvivo.com +44 20 7756 1300 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.