NCT05817435

A Phase 1 Bioequivalence Study of Efgartigimod PH20 SC Administered Via a Prefilled Syringe Versus a Vial+Syringe Presentation in Healthy Adults

A Phase 1, Randomized, Open-label, Parallel-Group, Single-Dose, Bioequivalence Study of Efgartigimod PH20 SC Administered Via a Prefilled Syringe Versus a Vial + Syringe Presentation in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: argenx · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, open-label, parallel-group, single-dose study comparing the pharmacokinetics of efgartigimod in blood following a single administration of efgartigimod PH20 SC via a prefilled syringe versus a vial + syringe in healthy participants.

Conditions

• Bioequivalence

Interventions

Type	Name	Description
BIOLOGICAL	efgartigimod PH20 SC as a prefilled syringe presentation	efgartigimod PH20 SC as a prefilled syringe presentation
BIOLOGICAL	efgartigimod PH20 SC as a vial + syringe presentation	efgartigimod PH20 SC as a vial + syringe presentation

Timeline

• Start date: 2023-03-13
• Primary completion: 2023-05-12
• Completion: 2023-05-12
• First posted: 2023-04-18
• Last updated: 2023-10-31

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study