Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A clinical study of MK-3508 in healthy people (MK-3508-006)

Doctors are studying a new medicine, called MK-3508, to understand how it affects healthy people. This is an early-stage study, meaning it's one of the first times the medicine is being tested in humans. The main goal is to find out if it's safe and how the body handles it. They also want to learn how much of the medicine to give and if it has any side effects. This research could eventually help protect people from Respiratory Syncytial Virus (RSV), a common virus that causes cold-like symptoms but can be more serious for some, especially young children and older adults. By studying healthy volunteers, researchers hope to gather important information that could lead to new ways of preventing or treating RSV in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

Start

23 Oct 2024

Respiratory syncytial virus infection

What is this study about?

This study, known by its scientific name MK-3508-006, is a very early step in developing a new medicine called MK-3508. The main purpose of this type of study is to understand how the medicine behaves in the human body. Researchers will be looking at things like how the body absorbs, uses, and gets rid of the medicine, as well as checking for any side effects. Because this is a new medicine, it’s only being tested in healthy people first to make sure it’s safe at different doses.

The medicine, MK-3508, is being developed to help with Respiratory Syncytial Virus (RSV) infection. RSV is a very common virus, especially in the colder months, that often causes mild, cold-like symptoms. However, it can be more serious for babies, young children, and older adults, sometimes leading to more severe breathing problems. At the moment, there's no specific cure for RSV, and prevention options are limited for many people.

By carefully studying MK-3508 in healthy volunteers, scientists hope to learn crucial information. This knowledge will help them decide if the medicine is promising enough to continue with further studies. If successful, this research could ultimately contribute to finding new and effective ways to prevent or treat RSV, potentially protecting many vulnerable people from this infection in the future.

Key takeaways

The study is testing a new medicine called MK-3508.
It's for healthy adults to check its safety and how it works in the body.
The aim is to help find new ways to tackle RSV, a common chest infection.
Participation involves regular visits, health checks, and taking the study medicine.
You'll be fully informed about the study before you decide to join.
You can stop participating at any time without giving a reason.

Who may be eligible?

To join this study, you need to be a healthy adult aged 18 or older. There is no upper age limit, meaning older adults can also take part if they meet all other health requirements.

Both men and women are welcome to participate. The researchers will have a list of health checks and other requirements to make sure it's safe for you to take part. For example, they'll want to ensure you don't have any serious ongoing health problems that could affect how your body reacts to the new medicine.

If you're interested, you'll have a screening appointment where doctors will review your medical history and do some tests to confirm you're a good fit for the study. You won't be able to join if you have certain health conditions or are taking specific medications that could interfere with the study medicine.

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?
Do you consider yourself generally healthy?
Are you able to attend regular clinic appointments?
Are you willing to take a new study medicine?
Are you comfortable with blood tests and health checks?
Do you understand that you could be male or female to join?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given the study medicine, MK-3508. The exact way it's given (for example, as a tablet, injection, or liquid) will be explained to you. You'll need to attend several visits to the clinic over a set period. During these visits, doctors and nurses will regularly check your health, take blood samples, and ask about any side effects you might be experiencing.

You'll be carefully monitored throughout the study. This might include regular health check-ups, having your vital signs (like blood pressure and heart rate) measured, and undergoing specific tests to see how the medicine is working in your body. There will also be follow-up appointments after you've finished taking the medicine, to make sure you're still doing well and to collect any final information. The total length of your involvement in the study, including all visits and follow-up, will be clearly explained to you before you agree to participate.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of joining this study is contributing to important medical research that could lead to new treatments for RSV, helping many people in the future. You will also receive careful medical monitoring and health checks throughout your participation. However, there are potential risks, as this is a new medicine and some side effects may not be known yet. You might experience uncomfortable side effects from the medicine, or the procedures involved (like blood tests). It's very important to remember that participating is entirely voluntary, and 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 virus that usually causes mild, cold-like symptoms, but it can be more serious for babies, young children, and older adults as it affects the lungs and breathing.

Why are you testing this medicine on healthy people?

Because MK-3508 is a new medicine, it's first tested in healthy people to make sure it's safe and to understand how the body handles it before trying it on people who are ill.

Will I get sick with RSV during the study?

This study is focused on understanding the new medicine's safety and how it works in healthy people. You will not be intentionally given RSV as part of this research.

Will I be paid for taking part?

Studies often offer some payment for your time and travel, but this varies. You should ask the study team about this directly.

How long will my involvement in the study last?

The total length of time you'd need to be involved, including all visits and follow-up, will be fully explained by the study team before you agree to take part.