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

First-in-human study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of VTX-PID in healthy male volunteers

This is a very early study, the first time this new medicine, VTX-PID, is being given to people. It's happening in the UK and involves healthy male volunteers. The main goals are to check if the medicine is safe and how well people tolerate it, meaning if there are any side effects. Researchers also want to understand how the body absorbs, uses, and gets rid of the medicine, and what effects it has. Participants need to have specific antibodies called 'Neutralising antibodies (NAbs) against AAV' in their blood. This kind of study helps us learn essential information about new treatments before they can be tested in larger groups of people who might have a particular illness.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Vivet Therapeutics

Enrolment target

Start

28 Sep 2023

Healthy volunteers with circulating Neutralising antibodies (NAbs) against AAV

What is this study about?

This study is an important first step in understanding a new medicine called VTX-PID. Think of it like taking a new car for its very first test drive – you want to make sure it's safe to drive, that all the parts work as expected, and how it handles on the road. In this case, the 'car' is VTX-PID, and the 'test drivers' are healthy male volunteers.

The main reasons for doing this study are to see if VTX-PID is safe when given to people for the first time, and if people can tolerate it without too many problems. Researchers will also be looking at how the body processes the medicine, like how long it stays in the system and what changes it might cause. This information is absolutely vital because it helps scientists decide if the medicine is promising enough to be studied further in people who might benefit from it in the future.

It's important to know that this is not a study looking to treat a specific illness yet. Instead, it's about gathering fundamental information on how VTX-PID behaves in humans. Knowing this helps to pave the way for bigger studies in the future, which might look at whether VTX-PID could help people with certain health conditions.

Key takeaways

This is an early-stage study testing a new medicine (VTX-PID) for the first time in humans.
It aims to check safety, how the body handles the medicine, and what it does.
Only healthy men, aged 18 and over, can take part.
Participants must have specific 'Neutralising antibodies (NAbs) against AAV' in their blood.
Taking part helps advance medical research, but the full side effects are not yet known.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to be a healthy man, aged 18 or older. There isn't an upper age limit mentioned, but you'll need to be in generally good health.

One specific requirement for this study is that you must have what are called 'Neutralising antibodies (NAbs) against AAV' in your blood. These are natural antibodies that your body might have developed, and the study team will test for them to see if you qualify.

If you're a healthy man over 18 and think you might have these specific antibodies (though most people wouldn't know without a test), this study could be an option for you to consider.

Quick self-check

Are you a man?
Are you 18 years old or older?
Are you generally healthy?
Are you willing to have blood tests to check for specific antibodies?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

Taking part in this study would involve several visits to a clinic over a period of time. You would first have a screening visit to check if you meet all the requirements, including blood tests for the specific antibodies. If you qualify, you would receive the study medicine, VTX-PID. This will be the very first time this medicine is given to humans, so you would be closely monitored by doctors and nurses.

Throughout the study, you'd likely have regular check-ups, blood tests, and other assessments to see how you're feeling, how the medicine is affecting you, and if there are any side effects. The exact number of visits, how long each visit lasts, and the total duration of your involvement in the study would be explained in detail by the study team. You'll also learn about any follow-up appointments after you've finished taking the medicine. Your study doctor will explain all these details fully.

Potential risks and benefits

The main benefit of taking part in a study like this is contributing to medical science and helping develop new medicines that could benefit others in the future. As this is the first time VTX-PID is being given to humans, there are potential risks, as the full range of side effects is not yet known. These might include mild side effects like a headache or feeling tired, or more serious, though less likely, reactions. All known potential risks will be explained clearly by the study team. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

—
Germany

Common questions

What is VTX-PID?

VTX-PID is a new medicine that is being tested for the very first time in humans.

What does 'Phase 1 study' mean?

Phase 1 means it's an early safety study, helping researchers learn if the medicine is safe and how it acts in the body.

Do I need to be ill to join?

No, this study is specifically looking for healthy male volunteers.

What are 'Neutralising antibodies (NAbs) against AAV'?

These are natural antibodies in your blood that the study team will test for to see if you can join.

Will I be paid to take part?

While this information isn't given here, studies often cover travel costs or offer compensation for your time. This would be discussed by the study team.