Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

MK-3508 Multiple Ascending Dose Study in Healthy Participants

This research study is investigating a new medication, MK-3508, which is being developed to treat or prevent Respiratory Syncytial Virus (RSV). RSV is a common chest infection that can be quite serious, especially for very young children and older adults. In this 'first-in-human' study, we're giving different small doses of MK-3508 to healthy adult volunteers. The main goal is to find out if the medicine is safe and well-tolerated. We also want to understand how the body absorbs, uses, and gets rid of the medicine. This is a very early stage of research, and volunteers will be carefully monitored by doctors and nurses to ensure their well-being.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

Start

19 Sep 2023

Respiratory syncytial virus infection

What is this study about?

This study is all about a new medicine, code-named MK-3508, which we hope could one day help people with Respiratory Syncytial Virus (RSV). RSV is a common virus that often causes mild, cold-like symptoms, but it can lead to more serious breathing problems, especially in babies, young children, and older adults.

Because this is the very first time this new medicine is being given to people, we need to be extra careful. The study is designed to answer some basic but very important questions: Is MK-3508 safe? What dose can people tolerate without too many side effects? And how does the body take in, process, and get rid of the medicine?

By carefully studying healthy volunteers, we can learn a lot about MK-3508 before we ever consider giving it to people who are actually sick with RSV. This is a crucial step in developing new medicines and making sure they are as safe and effective as possible for future patients.

Key takeaways

This study is testing a new medicine (MK-3508) for RSV.
It's a very early-stage study focusing on safety in healthy adults.
Volunteers will be closely monitored for how the medicine affects them.
Participation involves clinic stays and follow-up appointments.
You must be 18 or older and in good general health to participate.

Who may be eligible?

To be part of this study, you need to be a healthy adult aged 18 years or older. This means you shouldn't have any major ongoing health problems.

Both men and women are welcome to take part. The research team will do a thorough health check to make sure participating is safe for you.

They are looking for people who are generally well and not taking too many other medications, as this helps them understand the effects of the new medicine clearly.

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.

Am I 18 years old or older?
Do I consider myself to be generally healthy?
Am I willing to stay in a research clinic for a few days?
Am I comfortable having regular blood tests and medical checks?
Am I able to attend follow-up appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have a screening visit to check your health and make sure you're suitable for the study. If you qualify, you'll be admitted to a research clinic, usually for a few days, where you'll receive a dose of the study medicine, MK-3508.

During your stay, doctors and nurses will closely monitor your health. This will involve regular blood and urine tests, checking your heart with an ECG, and monitoring your vital signs like blood pressure and temperature. They will also ask you about any symptoms you might have. After you leave the clinic, you'll have some follow-up visits, which might be in person or over the phone, to continue tracking your progress. The total time you'd be involved in the study would be several weeks, from screening to your final follow-up.

Potential risks and benefits

Taking part in this study means you could be helping researchers understand a new medicine that might one day treat a common and sometimes serious illness. However, because this is a new medicine, there's always a chance of unknown side effects. We will start with very low doses, and you will be carefully watched for any problems. You have the right to leave 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 infects the lungs and breathing passages. It usually causes mild, cold-like symptoms, but it can be serious for babies and older adults.

Why are you testing this medicine on healthy people?

Because MK-3508 is a new medicine, it's very important to check its safety and how the body handles it in healthy volunteers first, before giving it to people who are unwell. This helps us learn about potential side effects without other illnesses making things complicated.

Will I get sick from RSV in this study?

No, this study is not about making you sick with RSV. We are testing a medicine that may help against RSV, but you will not be exposed to the virus as part of this research. You need to be healthy to participate.

What does 'multiple ascending dose' mean?

It means different groups of volunteers will receive different amounts of the medicine. We start with a very small dose and gradually increase it in later groups, as long as it's shown to be safe, to see how the body reacts to varying levels.

Will I get paid for taking part?

Many early-stage clinical trials offer some payment for your time and inconvenience. The study team will explain any compensation you might receive for participating.