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

A Single-Ascending-Dose Study of MK-4318 in Healthy Participants

This is a very early study for a new medicine called MK-4318, which is being explored for treating pain. It's the first time this medicine is being tested in people. The main goal is to check how safe it is and how much the body can tolerate. Healthy adult volunteers will be given single doses of the medicine, starting with a very small amount and gradually increasing it, to see how their bodies react. This type of study, called a Phase I trial, is crucial for understanding new medicines before they can be tested in larger groups of people who actually have pain. The information gathered from this study will help decide if MK-4318 has the potential to be a future treatment for both short-term and long-term pain.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Merck Sharp & Dohme LLC, Merck Sharp & Dohme LLC

Enrolment target

Start

26 Apr 2023

Acute and chronic pain

What is this study about?

This research study is about a new medicine, called MK-4318, that might help with different kinds of pain. Pain can be short-term, like after an injury, or long-term (chronic pain), like arthritis, which can affect someone's daily life significantly. Researchers are always looking for better and safer ways to manage pain, and this new medicine is one of those potential options.

This particular study is a very early step in checking if MK-4318 could be a good pain treatment. It's called a 'Phase I' study, which means it's the very first time the medicine is being given to people. The main purpose at this stage is not to treat pain, but to carefully check a few important things in healthy volunteers. We want to understand if the medicine is safe when given to humans, how their bodies react to it, and what are the safe amounts (doses) that can be given.

The findings from this study will help scientists decide if MK-4318 is promising enough to continue testing in larger groups of people, including those who actually live with pain. If successful, this new medicine could potentially offer a new way to help people manage their pain in the future.

Key takeaways

This is an early study for a new pain medicine, MK-4318.
It's the first time this medicine is being tested in people.
The main aim is to check its safety and how the body reacts to it.
Healthy adults, aged 18 and over, are needed as volunteers.
Participation helps advance medical research for future pain treatments.

Who may be eligible?

This study is looking for healthy adults to take part. This means you should generally be in good health, without any major ongoing medical conditions that might affect how your body handles the study medicine.

To be considered, you need to be at least 18 years old. There isn't an upper age limit mentioned, but you would still need to be healthy for your age. Both men and women are welcome to participate.

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 appointments at the study clinic?
Are you willing to follow study instructions carefully?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a screening visit to make sure you are healthy and meet all the study requirements. This would involve medical checks, blood tests, and a review of your health history.

If you qualify, you would then receive a single dose of the study medicine, MK-4318. The dose you receive would be carefully chosen by the study doctors, starting very low and increasing in small steps for different groups of volunteers. You would be closely monitored by medical staff for a period after taking the medicine to see how your body reacts and to check for any side effects. There might be several follow-up visits or phone calls to check on your well-being after you leave the clinic. The total duration of your participation, including all visits and follow-ups, would be explained to you in detail.

Potential risks and benefits

Participating in a study like this might not directly benefit your health, as the medicine isn't given to treat a condition you have. However, you would be contributing to medical science and helping to find new potential treatments for pain that could help many others in the future. As with any new medicine, there's a chance you might experience side effects, some of which could be unexpected or unpleasant. The study team will explain all known potential risks to you. 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 a Phase I study?

It's the first time a new medicine is given to people, usually healthy volunteers. The main goal is to check its safety and how the body handles it.

Will this medicine treat my pain?

No, this study is not designed to treat pain. It's for healthy volunteers to test the medicine's safety and how the body reacts to it.

How old do I need to be to join?

You need to be at least 18 years old. There isn't an upper age limit, but you must be in good general health.

Will I have to stay overnight at the clinic?

The study team will explain the exact schedule. Depending on the monitoring required, some visits might be longer, but it's not always an overnight stay.

What does 'single-ascending-dose' mean?

It means different groups of volunteers will each receive just one dose of the medicine, with each new group getting a slightly higher dose to find a safe amount.