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

NCT05817435 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-10-31

No results posted yet for this study

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

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-03-13
Primary Completion
2023-05-12
Completion
2023-05-12
FDA Drug
Yes

Countries

  • United States

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 NCT05817435 on ClinicalTrials.gov