Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

A Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of MK-3508 in Healthy Participants

This research is looking at a new medicine called MK-3508, which could one day help treat Respiratory Syncytial Virus (RSV) infection. RSV is a common respiratory illness, especially in young children and older adults. This is the very first time this medicine is being given to people. Researchers will test different doses in healthy adult men to see how safe it is, if it causes any side effects, and how the body processes it. This early study helps gather important information before the medicine can be tested in people who actually have RSV.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

Start

13 Mar 2023

Respiratory syncytial virus infection

What is this study about?

Imagine feeling unwell with a bad cold or flu, but it's not the flu – it could be something called Respiratory Syncytial Virus, or RSV. RSV is a common germ that can cause coughs, sneezes, and can sometimes be more serious, especially for babies and older people. The good news is, scientists are working hard to find new ways to treat it.

This study is an early step in testing a new medicine called MK-3508. Think of it like a brand new car being taken for its first test drive. The main goal right now isn't to treat RSV itself, but to carefully check how the medicine behaves in healthy people. This is really important to make sure it's safe before it can be given to people who are sick.

The researchers will be giving different, gradually increasing doses of MK-3508 to a small group of volunteers. They'll be watching very closely for any side effects and doing tests to understand how the medicine moves through the body and how quickly it leaves. This information is vital for future studies and helps doctors decide the best way to use the medicine later on.

Key takeaways

This is an early study of a new potential medicine (MK-3508) for RSV.
It's designed to check safety, side effects, and how the medicine works in the body.
Only healthy adult men aged 18 and over can take part.
Participants will receive a single dose of the study medicine.
It could help future patients by providing vital information about the new drug.

Who may be eligible?

This study is particularly looking for healthy adults. To take part, you need to be at least 18 years old.

Only men are being invited to participate in this specific study. This is common in the very early stages of testing a new medicine, as it can simplify the initial safety checks.

Crucially, you must be in good health. This means you shouldn't have any significant ongoing medical conditions or take regular medications that might interfere with how the new drug works or make it unsafe for you.

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 18 years old or older?
Are you a man?
Are you generally healthy with no major ongoing medical problems?
Are you able to attend appointments at the study clinic?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study medicine, MK-3508, in a single dose. This is a "first-in-human" study, meaning it's the first time the medicine is given to people. You would have regular check-ups with the study team. These check-ups will involve things like blood tests, urine tests, and monitoring your vital signs, such as your heart rate and blood pressure. The doctors will closely watch you for any side effects or changes in your health. You'll likely need to stay at a clinic for a short period and come back for follow-up visits to ensure the medicine has left your system and you remain well. The total time you'd be involved in the study, from your first visit to your last follow-up, would be explained fully by the study team.

Potential risks and benefits

Taking part in any research study has potential benefits and risks. For this early study, the main benefit isn't to you directly, but to help medical science learn more about this new medicine for RSV, which could help future patients. There are always potential risks with new medicines, including unexpected side effects that might be mild, serious, or even unknown at this stage. You would be closely monitored, and medical staff would be available to help with any side effects. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

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Unverified
Belgium

Common questions

What is RSV?

RSV stands for Respiratory Syncytial Virus. It's a common germ that can cause cold-like symptoms, including coughing and sneezing. It can be more serious for babies and older adults.

Why are only men eligible for this study?

In the very early stages of testing new medicines, it's common to start with a specific group like healthy men. This helps researchers carefully observe the medicine's effects without other factors that might complicate the results.

What does 'single ascending dose' mean?

It means a small number of volunteers will get one dose of the medicine. Then, new volunteers will get a slightly higher single dose, and so on, to find a safe amount.

Will I get paid to be in the study?

Payment for participation varies between studies. The study team will tell you if any reimbursement for your time and travel is available.

Is this medicine a cure for RSV?

No, this study is about checking the safety and how the body handles a new medicine, not yet about curing RSV. That would be tested in much later studies.