104 Participants NeededMy employer runs this trial

ARGX-124 for Healthy Volunteers

SC
IB
Overseen ByIrena Butrimiene, MD
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: argenx

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety of a new drug, ARGX-124, in healthy adults. Researchers aim to observe how the drug behaves in the body and how the immune system responds. Participants will receive either the drug or a placebo (a harmless pill with no effect) to compare outcomes. This trial suits healthy men and women who cannot have children, weigh between 50 and 120 kg, and have a BMI between 18 and 30.5. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Is there any evidence suggesting that ARGX-124 is likely to be safe for humans?

Research shows that ARGX-124 is undergoing testing to determine its safety for people. In earlier studies, researchers administered ARGX-124 to healthy volunteers to assess tolerance and effects. Although specific side effects from these studies are not detailed, the current trial phase indicates that researchers continue to gather basic safety information. They closely monitor participants' responses and any negative effects. Since ARGX-124 remains in early testing, information on its safety is limited. Participants in the trial will contribute valuable data on the treatment's tolerability.12345

Why do researchers think this study treatment might be promising?

ARGX-124 is unique because it represents a new class of experimental drugs that work by targeting specific mechanisms in the immune system. Unlike traditional treatments that often target symptoms or use broad-spectrum approaches, ARGX-124 is designed to modulate immune responses more precisely. Researchers are excited about this treatment because it has the potential to offer a more tailored approach, possibly leading to fewer side effects and improved outcomes. This precision in targeting could revolutionize how similar conditions are managed in the future.

What evidence suggests that ARGX-124 could be effective?

Research shows that ARGX-124 is a new drug being tested for safety and effects in healthy individuals. In this trial, participants will receive either ARGX-124 or a placebo. While detailed information on ARGX-124's effectiveness in treating diseases is limited, it belongs to a group of drugs known as FcRn blockers. These drugs have shown promise in reducing certain antibodies, potentially aiding in the management of autoimmune diseases. Early studies with similar drugs in healthy volunteers demonstrated a significant decrease in specific immune proteins, suggesting that ARGX-124 might help treat conditions involving an overactive immune system.12346

Are You a Good Fit for This Trial?

Inclusion Criteria

I am between 18 and 65 years old and legally able to consent.
I am either a man, or a woman who cannot become pregnant.
My weight is between 50 and 120 kg and my BMI is between 18 and 30.5.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive single and multiple ascending doses of ARGX-124 or placebo

Up to 19 weeks

Follow-up

Participants are monitored for safety, pharmacokinetics, pharmacodynamics, and immunogenicity after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • ARGX-124

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: ARGX-124Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

argenx

Lead Sponsor

Trials
76
Recruited
11,500+

Tim Van Hauwermeiren

argenx

Chief Executive Officer since 2008

B.Sc. and M.Sc. in Bioengineering from Ghent University, Executive MBA from The Vlerick School of Management

Dr. Peter Ulrichts

argenx

Chief Medical Officer since 2023

MD from Maastricht University, PhD in Molecular Immunology from Maastricht University

Citations

A Study to Assess the Safety of ARGX-124 in Healthy ...

It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...

argenx Reports First Quarter 2026 Financial Results and ...

Progressing two future FcRn molecules: ARGX-213 is Phase 3-ready and ARGX-124 is in Phase 1. Advancing empasiprubart. Empasiprubart is a first ...

A Study to Assess the Safety of ARGX-124 in Healthy Volunteers

This study aims to assess the safety of ARGX-124 in healthy adults. Another aim is to measure the amount of ARGX-124 in the blood over time ...

Argenx Opens Phase 1 Safety Trial for ARGX-124, ...

The main treatment is ARGX-124, a biological drug candidate given to healthy volunteers to see how well it is tolerated and how the immune ...

Document

It is the first approved FcRn blocker for the treatment of generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating ...

ARGX 124 - AdisInsight

ARGX 124 is a FcRn targeting candidate being developed by argenx for the treatment of an undisclosed indication.