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ARGX-124

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment104
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07377396A Study to Assess the Safety of ARGX-124 in Healthy VolunteersPHASE1 RECRUITING 104Jan 26, 2026Dec 31, 2026Mar 6, 20261 Canada
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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 — 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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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07377396primaryCompletionDate: changed
LOWMay 24, 2026NCT07377396studyFirstPostDate: changed