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ARGX-124

Phase 1

Healthy Volunteers | Monoclonal antibody | Other |argenx SE|Last Updated: Mar 6, 2026

Target and mechanism

Molecular targetFcRn
Target classProtein
ModalityMonoclonal antibody

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment104

FDA Designations

No designations recorded

Clinical trial landscape

ARGX-124 · 1 trial · 1 indication

Phase 1 1
NCT07377396A Study to Assess the Safety of ARGX-124 in Healthy VolunteersHealthy Volunteers
RECRUITING104 Analytics
PHASE1RECRUITING
A Study to Assess the Safety of ARGX-124 in Healthy Volunteers
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Study Endpoints

Primary Endpoints

Incidence of AEs, SAEs and AEs leading to ARGX-124 discontinuation
Up to 23 weeks

AE : adverse event ; SAE : serious adverse event.

Secondary Endpoints

Maximum observed serum concentration (Cmax)
Up to 23 weeks
Percent change from baseline in total IgG levels in serum over time
Up to 23 weeks
Incidence of ADA against ARGX-124 in serum
Up to 23 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ARGX-124EXPERIMENTALParticipants receiving the experimental drug
PlaceboPLACEBO_COMPARATORParticipants receiving placebo

Interventions

NameTypeDescription
ARGX-124BIOLOGICALAdministrations of ARGX-124
PlaceboOTHERAdministrations of placebo comparator
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Is at least the local legal age of consent and aged 18 to 65 years, inclusive, when signing the ICF. * Is a female of Nonchildbearing Potential (postmenopausal or surgically sterilized) or a male. * Has a body weight between 50 and 120 kg and a BMI between 18 and 30.5 kg/m2, i...

Countries:Canada
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Frequently asked questions about ARGX-124

What is ARGX-124 used for?

ARGX-124 is an investigational monoclonal antibody being studied for use in healthy volunteers. It is currently in Phase 1 clinical development, with a trial assessing its safety in healthy participants. The drug is not yet approved and is still in clinical trials.

What does ARGX-124 target?

ARGX-124 targets the neonatal Fc receptor (FcRn), a protein involved in antibody recycling. By targeting FcRn, the drug may modulate IgG levels, though its exact therapeutic application is still under investigation. This mechanism is being evaluated in early-stage clinical trials.

Who is developing ARGX-124?

ARGX-124 is being developed by argenx SE, a biopharmaceutical company listed on the stock exchange under the ticker ARGX. The company is conducting a Phase 1 clinical trial to evaluate the safety of ARGX-124 in healthy volunteers.

What phase is ARGX-124 in?

ARGX-124 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The ongoing Phase 1 trial is designed to assess the safety of ARGX-124 in healthy volunteers.

What clinical trials is ARGX-124 in?

ARGX-124 is being studied in a Phase 1 clinical trial with the identifier NCT07377396. This randomized, double-blind, placebo-controlled study is recruiting 104 healthy volunteers in Canada to assess the safety of ARGX-124. The trial is currently active and recruiting participants.