Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A randomized, single-blind, placebo-controlled, study to examine the safety, tolerability, and pharmacokinetics of M6229 administered as a 120-hour continuous infusion at two dose levels versus placebo in healthy subjects

This early research study is investigating a new medicine, known as M6229. We're giving it to healthy volunteers to understand if it's safe to use and how the body handles it. This type of study, called a Phase 1 trial, is a very early step in developing new treatments. The goal is to see if there are any side effects and how the medicine moves through the body over time. This information is crucial before testing the medicine in people who are actually unwell, especially those with serious conditions like sepsis. It helps us make sure that any future studies are as safe as possible for patients.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Matisse Pharmaceuticals B.V.

Enrolment target

Start

16 Oct 2024

Sepsis and Septic Shock

What is this study about?

This study is an early research step for a new medicine called M6229. Imagine testing a new car engine for the first time; you'd want to make sure it runs safely and you understand how it works before putting it into a car for everyday use. In the same way, this study is about checking if M6229 is safe when given to healthy people and to see how their bodies handle it.

The main aim is to understand if there are any side effects and how much of the medicine stays in the body and for how long. We'll be comparing M6229 to a 'dummy' treatment (placebo) to help us see the true effects of the real medicine. This is a very common and important way to test new medicines safely.

The information we gather from healthy volunteers in this study will help us decide if M6229 can go on to be tested in people who have serious health conditions like sepsis. Sepsis is a life-threatening reaction to an infection. It's vital that we thoroughly check new medicines for safety before giving them to patients who are already very poorly.

Key takeaways

This is an early study of a new medicine called M6229.
It aims to check the safety and how the medicine acts in healthy adults.
The information helps determine if M6229 can be tested for serious conditions like sepsis later.
Participation involves staying at a clinic for a few days for close monitoring.
You would contribute to important medical research.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to be a healthy adult, aged 18 or older. Both men and women can take part.

You will have a thorough check-up to make sure you are healthy enough to participate. This is to ensure your safety throughout the study.

More detailed information about who can and cannot join will be given by the study team, as it's important that each participant meets specific health requirements.

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 generally in good health?
Are you comfortable with potentially staying in a clinic for several days?
Are you able to attend follow-up visits or calls?
Are you willing to contribute to medical research?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be given the study medicine (M6229) or a dummy treatment (placebo) continuously for five days, likely through a drip in your arm. During this time, you would stay at the study clinic.

The research team will closely monitor you. This will involve regular check-ups, taking blood and urine samples, and recording any changes in how you feel. These checks help us understand how your body is reacting to the medicine.

After the five-day treatment period, there will be follow-up visits or calls to see how you are doing. The exact number and timing of these follow-up checks will be explained by the study team. The overall duration of your involvement, from the first screening visit to the last follow-up, will be detailed to you.

Potential risks and benefits

The main potential benefit of taking part in this early study is that you would be contributing to medical research that could one day help people with serious illnesses like sepsis. You might also receive free medical check-ups during the study. However, because this is an early study with a new medicine, there might be unknown side effects or discomfort. You would be closely monitored by the study team to identify and manage any issues. Remember, you can choose 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
Germany

Common questions

What is M6229?

M6229 is a new medicine that is being tested for the very first time in people in this study.

Why is this study only looking at healthy people?

Testing new medicines in healthy people first helps us understand their basic safety and how they work in the body before we give them to people who are unwell.

What is sepsis?

Sepsis is a very serious and life-threatening reaction your body has to an infection.

Will I know if I'm getting the real medicine or the dummy treatment?

No, this study is 'single-blind', meaning you won't know if you're getting M6229 or the placebo. This helps us get clearer results.

Will I be paid to take part?

Information about any payment for your time and inconvenience will be explained by the study team.