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

A PHASE 1, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED SINGLE CENTER STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SINGLE ASCENDING DOSES OF REGN7999, A TMPRSS6 ANTAGONIST, IN HEALTHY ADULT SUBJECTS

This is an early-stage research study, called a Phase 1 trial, looking into a new medicine named REGN7999. We're testing it in healthy adult volunteers to understand how safe it is and how well the body tolerates it. We're also checking how much medicine stays in the body over time and what effects it might have. REGN7999 is being developed to potentially help people with health problems caused by having too much iron in their body. The study involves giving different single doses of the medicine or a dummy treatment (placebo) to see if there are any side effects. Our main goal is to identify any unwanted reactions from the treatment.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Regeneron Pharmaceuticals Inc.

Enrolment target

Start

03 Oct 2022

Healthy - R7999 being developed for the treatment of diseases associated with iron overload.

What is this study about?

This study is an early step in developing a new medicine called REGN7999. Think of it like taking a brand-new car for its first test drive – we want to make sure it's safe to use before we try it out more widely. In this Phase 1 trial, we will be carefully checking how REGN7999 affects healthy people.

The main things we want to find out are if the medicine is safe and if people can take it without too many problems. We'll also be looking at how the body absorbs and processes the medicine, and what effects it might have. This information is really important because REGN7999 is being developed to help people who have health conditions because they have too much iron in their body. By understanding how it works in healthy individuals first, we can ensure it's safe to move on to studies with patients who have these conditions.

You might be wondering why we're testing it in healthy people if it's for people with a condition. In these very first studies, it's safer to test new medicines on healthy volunteers because we don't want to complicate the results with existing health issues. This way, we can clearly see any effects the medicine has on its own.

Key takeaways

This is an early-stage study (Phase 1) of a new medicine called REGN7999.
It aims to check the safety and how the body handles REGN7999 in healthy adults.
REGN7999 is being developed for conditions caused by too much iron in the body.
Participants will receive either the medicine or a dummy treatment (placebo).
The study involves regular visits over 5 to 6 months to monitor health and collect samples.

Who may be eligible?

This study is looking for healthy adult volunteers. To be able to take part, you need to be at least 18 years old. There's no upper age limit mentioned.

Both men and women can participate in this study. The most important thing is that you are generally healthy and don't have certain medical conditions that might interfere with the study medicine or results.

A healthcare professional will review your medical history and conduct some checks to make sure this study is right for you and that you meet all the 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 or older?
Are you generally healthy?
Are you able to attend study visits for up to 6 months?
Are you comfortable with receiving either an IV or subcutaneous injection?
Are you comfortable with regular blood tests?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would be assigned to either receive the new medicine, REGN7999, or a dummy treatment (placebo). Neither you nor the study team would know which you are receiving, which helps make the results fair.

You would receive a single dose of the treatment, either given into a vein (intravenously, or IV) or as an injection under the skin (subcutaneously, or SC). Over the course of the study, you would come in for several visits. These visits would involve check-ups, blood tests to see how the medicine is working and to check for any side effects, and generally monitoring your health. The total duration of your participation would be either 20 weeks (about 5 months) or 26 weeks (about 6 months), depending on which group you are in. Throughout this time, your health would be carefully monitored.

Potential risks and benefits

As with any new medicine, there are potential risks involved. You might experience side effects, which could be mild or, in rare cases, more serious. The study team will carefully monitor you for any such reactions. While this is an early-stage study primarily focused on safety, any information learned will help in developing treatments for iron overload conditions. 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
Belgium

Common questions

What does 'Phase 1' mean?

Phase 1 is the first time a new medicine is tested in people. It's mainly to check if it's safe and how the body handles it.

What is a 'placebo'?

A placebo is a dummy treatment, often a sugar pill or saline injection, that looks exactly like the real medicine but contains no active ingredients. It helps us compare the effects of the actual medicine fairly.

Why are you testing in healthy people?

We test in healthy people first to make sure the medicine is safe on its own and to understand its basic effects without complications from other health conditions.

What is REGN7999 for?

REGN7999 is being developed to treat conditions where people have too much iron in their body.

What does a 'single ascending dose' mean?

It means different groups of volunteers will receive one dose of the medicine, and each group will get a slightly higher dose than the previous one, as long as it remains safe.