AuthorisedHuman Pharmacology (Phase I)- First administration to humansInterventional

A First in Human Study to Assess Safety, Tolerability and Pharmacokinetics of a single dose of REGN22044 in Healthy Adults

This is a very early-stage study, called a Phase 1 trial, looking at a new medicine called REGN22044. It’s the first time this medicine will be given to people. The main goals are to check if it’s safe and how well healthy adults tolerate a single dose. We also want to understand how the body processes the medicine – how it’s absorbed, distributed, broken down, and removed. By carefully observing healthy volunteers, researchers can learn important information about REGN22044 before it might be tested in people with specific diseases. This helps make sure future studies are as safe as possible.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Regeneron Pharmaceuticals Inc.

Enrolment target

Start

11 May 2026

Heathy volunteer trial

What is this study about?

This study is a very important first step in bringing a new medicine, called REGN22044, to people. Think of it like a new car model being tested on a private track before it's allowed on public roads. For this study, scientists are giving a single dose of REGN22044 to healthy adults for the very first time.

The main reasons for doing this study are to make sure the medicine is safe and that people can tolerate it without too many problems. They'll also be looking at how the body handles the medicine – how much of it gets into the blood, how long it stays there, and how the body gets rid of it. This information is crucial because it helps researchers decide on the right dose and how often it might be given in future studies.

Because this is the very first time REGN22044 is being given to humans, it's called a 'Phase 1' study. These studies are designed with great care and have strict safety checks. The information gathered from healthy volunteers in this study will help researchers understand if it's safe to continue testing this medicine in the future, possibly for a specific illness.

Key takeaways

This study is testing a new medicine (REGN22044) for the first time in people.
It's a Phase 1 study, focusing on safety, how the body handles the medicine, and how well people tolerate it.
Only healthy adults, aged 18 and over, of any gender can participate.
You would receive a single dose and have regular health check-ups.
Your participation helps future medical research, but there's no direct health benefit to you.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for healthy adults. This means you should generally be in good health and not have any serious medical conditions.

To take part, you must be at least 18 years old. There is no upper age limit, meaning older adults can also participate, as long as they meet the other health requirements.

Both men and women are welcome to join this study. The researchers want to include a diverse group of people to understand how the medicine affects different individuals.

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 at least 18 years old?
Do you consider yourself generally healthy?
Are you able to attend several clinic visits?
Are you comfortable potentially taking an experimental medicine?
Are you male or female?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve several visits to a clinic. You would receive a single dose of the study medicine, REGN22044. Before and after taking the medicine, you would have various assessments. These typically include physical examinations, blood tests, urine tests, and monitoring of your vital signs, like blood pressure and heart rate. You might need to stay at the clinic for a short period after receiving the dose so doctors can carefully watch for any immediate effects. You would also have follow-up visits to ensure your health is good and to collect more information about how your body is handling the medicine. The total duration of your involvement could range from a few weeks to a couple of months, depending on the specific schedule of visits and follow-ups outlined by the study team.

Potential risks and benefits

Taking part in this study means you could help scientists learn important information about a new potential medicine. While there's no direct personal health benefit for you from taking part, your contribution helps advance medical research for others. There are potential risks, as with any new medicine, including possible side effects that are not yet fully known. The study team will explain all known risks to you. 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
Belgium

Common questions

What does 'first in human study' mean?

It means this is the very first time this new medicine is being given to people to see how it affects them.

Why is this study for healthy people?

Researchers test new medicines in healthy people first to understand basic safety and how the body handles it before testing in people who are already unwell.

What does 'single dose' mean?

It means you would only receive the medicine once during the study, not multiple times.

What is 'pharmacokinetics'?

This is a fancy way of saying we want to understand what the body does to the medicine – how it gets into your system, moves around, and leaves the body.

Will I get paid to take part?

Sometimes studies offer payment for your time and travel, but this is something you should ask the study team directly.