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A Study to Assess the Bioequivalence of Efgartigimod PH20 SC Between Autoinjector and Prefilled Syringe in Healthy Adult Participants
Sponsor: argenx
Summary
The aim of this study is to compare the amount of efgartigimod in the blood over time after it is injected via Prefilled syringe (PFS) and Autoinjector (AI). The study will comprise 2 study periods of 3 weeks each. Each participant receives both efgartigimod PH20 SC AI and PFS treatments, in a different order. Participants will be in the study for up to approximately 9 weeks.
Official title: A Phase 1, Open-Label, Randomized, Single-Dose, 2-Period Crossover, Bioequivalence Study of Efgartigimod PH20 SC Administered Via Autoinjector Versus Prefilled Syringe in Healthy Adult Participants
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
32
Start Date
2026-06-19
Completion Date
2026-09-23
Last Updated
2026-10-14
Healthy Volunteers
Yes
Interventions
Efgartigimod PH20 SC via PFS
Subcutaneous injection of empasiprubart via Prefilled syringe (PFS)
Efgartigimod PH20 SC via AI
Subcutaneous injection of empasiprubart via Autoinjector (AI)
Locations (1)
Altasciences
Montreal, Canada