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

August 20, 2026 updated by: argenx

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment sequence 1
Participants randomized to receive Efgartigimod PH20 SC via AI in period 1 and Efgartigimod PH20 SC via PFS in period 2
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)
Experimental: Treatment sequence 2
Participants randomized to receive Efgartigimod PH20 SC via PFS in period 1 and Efgartigimod PH20 SC via AI in period 2
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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary PK parameter: AUC0-t
Time Frame: Up to 9 weeks
AUC0-t = area under the curve from time 0 to the last measurable time point
Up to 9 weeks
Secondary PK parameter: AUC0-168h
Time Frame: Up to 9 weeks
AUC0-168h = area under the curve from time 0 to 168 hours
Up to 9 weeks
Secondary PK parameter: CL/F
Time Frame: Up to 9 weeks
CL/F = apparent clearance from plasma after extravascular administration
Up to 9 weeks
Secondary PK parameter: Vz/F
Time Frame: Up to 9 weeks
Vz/F = apparent volume of distribution at steady state after extravascular administration
Up to 9 weeks
Secondary PK parameter: Tmax
Time Frame: Up to 9 weeks
Tmax = time to Cmax
Up to 9 weeks
Secondary PK parameter: t½
Time Frame: Up to 9 weeks
t½ = half-life
Up to 9 weeks
Incidence of AEs, SAEs, and AEs leading to efgartigimod discontinuation
Time Frame: Up to 9 weeks
AE = adverse event ; SAE = serious adverse event
Up to 9 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

argenx

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2026

Primary Completion (Estimated)

September 18, 2026

Study Completion (Estimated)

September 18, 2026

Study Registration Dates

First Submitted

August 20, 2026

First Submitted That Met QC Criteria

August 20, 2026

First Posted (Actual)

August 24, 2026

Study Record Updates

Last Update Posted (Actual)

August 24, 2026

Last Update Submitted That Met QC Criteria

August 20, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • ARGX-113-1-HV-1001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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