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ARGX-213

Phase 1

Healthy Volunteers | Monoclonal antibody | Other |argenx SE|Last Updated: Apr 23, 2026

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

Clinical trial landscape

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 used for?

ARGX-213 is an investigational monoclonal antibody being studied in healthy volunteers. It is currently in Phase 1 clinical development, with a completed trial assessing its safety in this population. The drug is not approved for any indication and remains under investigation.

Who makes ARGX-213?

ARGX-213 is being developed by argenx SE, a biopharmaceutical company traded on the NASDAQ under the ticker ARGX. The company is conducting clinical trials to evaluate the safety of this investigational monoclonal antibody in healthy volunteers.

What phase is ARGX-213 in?

ARGX-213 is in Phase 1 clinical development. A Phase 1 trial, NCT06968338, has been completed, evaluating the safety of the drug in healthy volunteers. As an investigational agent, ARGX-213 is not yet approved and is still in early-stage clinical testing.

What clinical trials is ARGX-213 in?

ARGX-213 has one completed Phase 1 clinical trial, NCT06968338, titled 'A Study to Assess the Safety of ARGX-213 in Healthy Volunteers.' This randomized, double-blind, placebo-controlled study enrolled 88 participants in Canada, with a minimum age of 18 years.

Is ARGX-213 a monoclonal antibody?

Yes, ARGX-213 is a monoclonal antibody. It is being developed by argenx SE as an investigational therapy. Currently, it is in Phase 1 clinical trials, with a completed study assessing its safety in healthy volunteers.