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efgartigimod PH20 as a prefilled syringe presentation

Phase 1

Bioequivalence | Monoclonal antibody | Other |argenx SE|Last Updated: Oct 31, 2023

Target and mechanism

ModalityMonoclonal antibody

Also known as efgartigimod PH20 SC as a prefilled syringe presentation

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment120

FDA Designations

No designations recorded

Clinical trial landscape

efgartigimod PH20 as a prefilled syringe presentation · 1 trial · 1 indication

Phase 1 1
NCT05817435A Phase 1 Bioequivalence Study of Efgartigimod PH20 SC Administered Via a Prefilled Syringe Versus a Vial+Syringe Presentation in Healthy AdultsBioequivalence
COMPLETED120 Analytics
PHASE1COMPLETED
A Phase 1 Bioequivalence Study of Efgartigimod PH20 SC Administered Via a Prefilled Syringe Versus a Vial+Syringe Presentation in Healthy Adults
Bioequivalence
NCT05817435120
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Study Endpoints

Primary Endpoints

Primary PK parameters (Cmax)
Up to 29 days

maximum observed plasma concentration

Primary PK parameters (AUC0-inf)
Up to 29 days

area under the concentration-time curve from 0 to infinity

Secondary Endpoints

Total IgG as percent change from baseline over time
up to 57 days
Total IgG as absolute change from baseline over time
up to 57 days
Safety parameters (number of AEs)
up to 85 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeOTHER

Treatment Arms

ArmTypeDescription
Efgartigimod PH20 SC - prefilled syringeEXPERIMENTALefgartigimod PH20 SC administered by a prefilled syringe
Efgartigimod PH20 SC - vial + syringeACTIVE_COMPARATORefgartigimod PH20 SC administered by a vial + syringe

Interventions

NameTypeDescription
efgartigimod PH20 SC as a prefilled syringe presentationBIOLOGICALefgartigimod PH20 SC as a prefilled syringe presentation
efgartigimod PH20 SC as a vial + syringe presentationBIOLOGICALefgartigimod PH20 SC as a vial + syringe presentation
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Is at least the local legal age of consent for participation in a clinical study and ≤55 years when signing the ICF * Is capable of providing signed informed consent, and complying with protocol requirements * Agrees to use contraceptive measures consistent with local regulati...

Countries:United States
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