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

NCT07782775 | Recruiting Phase 1

• 1 other identifier: ARGX-113-1-HV-1001
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Primary PK parameter: Cmax

  Cmax = maximum observed concentration

  Up to 9 weeks

• Primary PK parameter: AUC0-inf

  AUC0-inf = area under the curve from time 0 to infinity

  Up to 9 weeks

Secondary Outcomes (7)

• Secondary PK parameter: AUC0-t

  Up to 9 weeks

• Secondary PK parameter: AUC0-168h

  Up to 9 weeks

• Secondary PK parameter: CL/F

  Up to 9 weeks

• Secondary PK parameter: Vz/F

  Up to 9 weeks

• Secondary PK parameter: Tmax

  Up to 9 weeks

Study Arms (2)

Treatment sequence 1

EXPERIMENTAL

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; Biological: Efgartigimod PH20 SC via AI

Treatment sequence 2

EXPERIMENTAL

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; Biological: Efgartigimod PH20 SC via AI

Interventions

Efgartigimod PH20 SC via PFS BIOLOGICAL

Subcutaneous injection of empasiprubart via Prefilled syringe (PFS)

Treatment sequence 1; Treatment sequence 2

Efgartigimod PH20 SC via AI BIOLOGICAL

Subcutaneous injection of empasiprubart via Autoinjector (AI)

Treatment sequence 1; Treatment sequence 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• argenx: lead

Study Sites (1)

Altasciences

Montreal, H3P 3P1, Canada

RECRUITING

Central Study Contacts

Sabine Coppieters, MD

CONTACT

857-350-4834; clinicaltrials@argenx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 24, 2026
• Study Start: June 19, 2026
• Primary Completion (Estimated): September 18, 2026
• Study Completion (Estimated): September 18, 2026
• Last Updated: August 24, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)