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ARGX-213

Phase 1

Undisclosed | Monoclonal antibody | Other |argenx SE|Trials Updated: Apr 23, 2026

ARGX-213 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since May 2025

ARGX-213 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 Enrollment88

FDA Designations

No designations recorded

ARGX-213 clinical trials

ARGX-213 · 1 trial · 1 indication

Phase 1 1
NCT06968338A Study to Assess the Safety of ARGX-213 in Healthy VolunteersHealthy Volunteers
COMPLETED88 Analytics
PHASE1COMPLETED
A Study to Assess the Safety of ARGX-213 in Healthy Volunteers
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Study Endpoints

Primary Endpoints

Incidence of adverse events, serious adverse events, and adverse events leading to the discontinuation
Up to 17 weeks

Secondary Endpoints

ARGX-213 serum concentrations
Up to 17 weeks
Percent change from baseline in total IgG concentrations in serum
Up to 17 weeks
Incidence of antidrug antibodies against ARGX-213 in serum
Up to 17 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ARGX-213EXPERIMENTALParticipants receiving the experimental drug
PlaceboPLACEBO_COMPARATORParticipants receiving placebo

Interventions

NameTypeDescription
ARGX-213BIOLOGICALIntravenous or subcutaneous administrations of ARGX-213
PlaceboOTHERIntravenous or subcutaneous administrations of placebo
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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 for clinical studies and is aged 18 to 65 years, inclusive, when signing the ICF * Is a female of nonchild bearing potential (either postmenopausal or surgically sterilized) or a male * Has a body weight between 50 and 100 kg and a BM...

Countries:Canada
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Frequently asked questions about ARGX-213

What is ARGX-213?

ARGX-213 is an investigational monoclonal antibody developed by argenx SE. It is in Phase 1 clinical development, with one completed Phase 1 trial conducted in healthy adult volunteers. No approved indication has been announced for ARGX-213.

What does ARGX-213 target?

ARGX-213 targets FcRn, the neonatal Fc receptor. FcRn is a protein that recycles immunoglobulin G antibodies and extends their circulation time in the body. By binding FcRn, ARGX-213 is designed to interact with this recycling pathway.

Who makes ARGX-213?

ARGX-213 is developed by argenx SE, the Belgian immunology company listed on Nasdaq under the ticker ARGX. Argenx is the sponsor of the clinical program evaluating ARGX-213.

What phase is ARGX-213 in?

ARGX-213 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA or any other regulatory agency. The Phase 1 program has completed one trial, and no active trials are currently listed.

What clinical trials is ARGX-213 in?

ARGX-213 has been studied in one Phase 1 trial, NCT06968338, titled A Study to Assess the Safety of ARGX-213 in Healthy Volunteers. That trial was completed, enrolled 88 participants, was randomized, double blind, and placebo controlled, and was conducted in Canada.