RecruitingPHASE1INTERVENTIONAL

Phase 1 Single Ascending Doses (SAD) of M5542 in Healthy Participants

This study is an early investigation (Phase 1) into a new medicine, M5542. It's designed for healthy volunteers aged 18 to 50. The main goal is to find out if M5542 is safe, what side effects it might cause, and how the body processes it after a single dose given under the skin. Researchers will also look at how the body reacts to the medicine and if it creates an immune response. This type of study is crucial for understanding new treatments before they are tested in people who are unwell, helping to ensure future patient safety.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Enrolment target

Start

12 Sep 2024

Estimated completion

09 Mar 2027

Healthy

What is this study about?

This research is an early-stage study, often called 'Phase 1', which is the first time a new medicine is given to people. In this particular study, the new medicine is named M5542. The main purpose is to carefully check if M5542 is safe and well-tolerated when given in different dose amounts. Because it's so early, it's being tested in healthy volunteers, rather than people with a specific illness. This helps researchers understand the basic effects of the medicine without other health conditions making it complicated.

The medicine, M5542, will be given as a single injection under the skin. We'll be looking to see if there are any side effects, how the body deals with the medicine over time (like how long it stays in the system), and if it triggers any immune response. The information gathered from this study is really important. It helps scientists decide if M5542 is safe enough to continue testing in later studies with more people, including those who have the condition M5542 might eventually treat.

Think of it like testing a new car engine for the first time – you want to make sure it runs smoothly and safely before you put it into a full car and take it on the road. This study is doing the same for M5542, gathering essential safety information to guide its development.

Key takeaways

This is an early-stage study of a new medicine called M5542.
It's primarily checking the safety and how the body handles M5542 in healthy volunteers.
You will receive a single injection under the skin.
Participation involves medical checks, a clinic stay, and follow-up visits.
You must be a healthy adult between 18 and 50 years old.
You could receive either the active medicine or a placebo.

Who may be eligible?

To join this study, you need to be a healthy adult between 18 and 50 years old. You must weigh between 50 and 100 kilograms (roughly 7 stone 12 pounds to 15 stone 10 pounds) and have a body mass index (BMI) between 18 and 30, which is considered a healthy weight range.

There are several reasons why you might not be able to participate. For example, if you have any serious long-term health conditions affecting your breathing, digestion, kidneys, heart, or immune system, or if you've had cancer in the past. You also can't have had any significant infections recently or received any vaccines within the last 6 weeks, or plan to have a vaccine in the next three months after getting the study medicine.

The research team will carry out a thorough health check to make sure it's safe for you to take part and that nothing in your health history would affect the study's results.

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 50 years old?
Do you feel generally healthy, with no major ongoing health problems?
Is your weight between 50 and 100 kg (about 7 stone 12 lbs to 15 stone 10 lbs)?
Have you not had any recent significant infections (e.g., flu with hospitalisation in last 6 months)?
Have you not had any vaccinations in the last 6 weeks, or do you plan to have one in the next 3 months?
Have you never had cancer?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have a screening visit where doctors will check your health to make sure you're suitable. This includes a physical exam, blood tests, and checking your medical history. If you're eligible, you'll then be admitted to a clinic for a short stay. During this time, you will receive a single dose of either M5542 or a placebo (a dummy medicine with no active ingredient) as an injection under your skin. You won't know which one you're receiving.

Throughout your stay, and during follow-up visits, the study team will closely monitor you. They will take blood and urine samples, check your vital signs, and ask about any side effects you might be experiencing. The total duration of your participation, from the initial screening to the last follow-up, will be explained in detail by the study team, but typically involves several visits over a period of weeks to months.

Potential risks and benefits

The potential benefits for you as an individual in a Phase 1 study are generally limited, as the main goal is to gather information for future patients. However, you will receive thorough medical checks and contribute to medical science. As with any new medicine, there are potential risks, including discomfort or bruising at the injection site, and unexpected side effects that are not yet known. The study team will explain all known or potential risks to you. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Clinical Pharmacology Unit of Nuvisan GmbH
Verified postcode
Neu-Ulm, Germany· Recruiting

Common questions

What is M5542?

M5542 is a new medicine being developed that is in its very early stages of testing. Its specific purpose isn't shared at this stage, as the focus is solely on its safety in healthy people.

Will I get the actual medicine or a dummy?

You will either receive M5542 or a placebo (a dummy medicine with no active ingredient). You won't know which one you're given, nor will the study team.

How will the medicine be given?

The medicine will be given as a single injection under your skin, similar to some common vaccines.

What does 'healthy participants' mean?

It means you should be generally well, without any major ongoing health problems or recent serious illnesses, as determined by a full health check by the study doctors.

How long will I be involved in the study?

The total time you'd be involved, from initial checks to final follow-up, will be fully explained by the study team. It typically involves a short stay at a clinic and then follow-up appointments over several weeks.

How to find out more

Communication Center

service@emdgroup.com +49 6151 72 5200 Official trial record

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