Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study to investigate VMX-C001 in healthy volunteers.

This research is looking at a new medicine called VMX-C001. It's a study in healthy people to understand how the medicine works in the body and if it's safe. The goal of this new medicine is to help people who are taking blood thinning medications (like DOACs) and are experiencing bleeding. It could also be used for those who need to stop their blood thinner working quickly before having urgent surgery. This is an early stage of testing, meaning it's the first time the medicine is being given to people. The information gathered will help researchers decide if VMX-C001 can be tested in patients who might benefit from it in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

VarmX B.V.

Enrolment target

Start

29 May 2024

To restore coagulation in patients taking DOACs who are experiencing bleeding or who require reversal of anticoagulation prior to urgent surgery.

What is this study about?

This study is a very early step in developing a new medicine called VMX-C001. Imagine your blood has a natural way to clot and stop bleeding. Some medicines, called blood thinners (like DOACs), are given to prevent harmful blood clots. While these medicines are very helpful, they can also increase the risk of bleeding, or make it hard to stop bleeding if it happens.

VMX-C001 is designed to quickly reverse the effects of these blood thinners. This could be incredibly important for people who are bleeding because of their blood thinner, or for those who need urgent surgery and can't wait for the blood thinner to wear off naturally. By quickly making the blood clot normally again, it could prevent serious problems.

Because this is an early study, researchers are giving VMX-C001 to healthy volunteers. This helps them understand how the medicine behaves in the body, what dose is safe, and if there are any side effects, before giving it to people who are unwell. This careful approach is a standard and important part of bringing new medicines to patients.

Key takeaways

Tests a new medicine, VMX-C001, in healthy volunteers.
Aims to reverse effects of blood thinners for bleeding or urgent surgery.
It's an early-stage study to check safety and how it works.
Open to healthy adults, both men and women, aged 18 and over.
Participation involves clinic visits and close monitoring.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for healthy adults to take part. To be eligible, you need to be at least 18 years old. There is no upper age limit, meaning older adults can also participate.

Both men and women are welcome and encouraged to join this study. The researchers want to understand how the new medicine works in a diverse group of people.

Because this is a study for healthy volunteers, you would likely need to be in good general health. If you have any ongoing medical conditions or take regular medications, the study team would check if you're suitable. They will make sure it's safe for you to take part.

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 able to attend several clinic visits?
Are you comfortable with blood tests and medical checks?
Are you not currently taking any medicines that might affect your eligibility (the study team will check this)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be given the new medicine, VMX-C001, at set times. Because this is an early study, you would likely have several visits to a clinic or hospital for doctors and nurses to monitor your health very closely. They would check your vital signs, take blood samples, and ask you about how you are feeling. The total time you would be involved in the study would depend on the specific plan but would be explained in full before you agree to take part.

Potential risks and benefits

Taking part in any study has potential benefits and risks. For healthy volunteers in an early study like this, there isn't a direct health benefit to you, but you would be helping to advance medical knowledge that could benefit many patients in the future. Potential risks could include side effects from the new medicine, discomfort from blood tests or procedures, or unexpected reactions. However, the study team will monitor you closely for your safety, 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
Netherlands

Common questions

What is the main goal of this study?

The main goal is to understand how a new medicine, VMX-C001, works in healthy people and to check if it's safe.

Why are healthy people needed for this study?

Testing new medicines in healthy people first helps researchers understand how they work and what side effects might occur before giving them to patients who are unwell.

What kind of medicine is VMX-C001 for?

It's designed to quickly stop bleeding caused by blood thinners, or to reverse their effect before urgent surgery.

Will I get paid for taking part?

The study team will tell you if there is any payment for your time and travel, as this can vary between studies.

What happens after this study?

If VMX-C001 is found to be safe and works as expected, it will move on to further studies in patients who could benefit from it.