A Study to Assess the Bioequivalence of Efgartigimod PH20 SC Between Autoinjector and Prefilled Syringe in Healthy Adult Participants

NCT07782775 · tracked via the Priya Life Science Canada tracker

Sponsor

argenx

Phase

Phase 1

Started

2026-06-19

Last updated

2026-08-24

Condition(s) studied

Healthy VolunteerHealthy Adult Participants

Investigational drug(s) / intervention(s)

Efgartigimod PH20 SC via PFSEfgartigimod PH20 SC via AI

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)

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

55 Years

Healthy volunteers

Accepted

Inclusion Criteria: * Is at least the local legal age of consent and aged 18 to 55 years, inclusive, when signing the ICF. * Has a body weight between 50 and 100 kg and a BMI between 18 and 30 kg/m2, inclusive. Exclusion Criteria: * Has any current or past clinically meaningful medical or psychiatric condition that, in the investigator's opinion, would confound the study results or put the participant at undue risk. * Has received any medications, including nonprescription and prescription medications, within 2 weeks before the first IMP administration, except for hormonal contraceptives and hormone replacement therapy in female participants. The occasional use of acetaminophen or ibuprofen is allowed. * Previously participated in an efgartigimod clinical study and received at least 1 dose of IMP.

Primary outcome measure(s)

Primary PK parameter: Cmax — Up to 9 weeks
Cmax = maximum observed concentration
Primary PK parameter: AUC0-inf — Up to 9 weeks
AUC0-inf = area under the curve from time 0 to infinity

Trial sites (1)

Facility	City	Region	Status
Altasciences	Montreal	Canada	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07782775 on ClinicalTrials.gov ↗ ← All trials in Canada