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

NCT07782775 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-08-24

No results posted yet for this 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.

Conditions

  • Healthy Volunteer
  • Healthy Adult Participants

Interventions

BIOLOGICAL

Efgartigimod PH20 SC via PFS

Subcutaneous injection of empasiprubart via Prefilled syringe (PFS)

BIOLOGICAL

Efgartigimod PH20 SC via AI

Subcutaneous injection of empasiprubart via Autoinjector (AI)

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-19
Primary Completion
2026-09-18
Completion
2026-09-18

Countries

  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07782775 on ClinicalTrials.gov