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NCT Number: NCT07782775

A Study to Assess the Bioequivalence of Efgartigimod PH20 SC Between Autoinjector and 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.

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Key information

Conditions

Healthy Volunteer Healthy Adult Participants

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Efgartigimod PH20 SC via PFS

Biological

Subcutaneous injection of empasiprubart via Prefilled syringe (PFS)

Efgartigimod PH20 SC via AI

Biological

Subcutaneous injection of empasiprubart via Autoinjector (AI)

Primary outcomes

  1. Primary PK parameter: Cmax

    Time frame: Up to 9 weeks

    Cmax = maximum observed concentration

  2. Primary PK parameter: AUC0-inf

    Time frame: Up to 9 weeks

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

Secondary outcomes

  1. 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

  2. Secondary PK parameter: AUC0-168h

    Time frame: Up to 9 weeks

    AUC0-168h = area under the curve from time 0 to 168 hours

  3. Secondary PK parameter: CL/F

    Time frame: Up to 9 weeks

    CL/F = apparent clearance from plasma after extravascular administration

  4. Secondary PK parameter: Vz/F

    Time frame: Up to 9 weeks

    Vz/F = apparent volume of distribution at steady state after extravascular administration

  5. Secondary PK parameter: Tmax

    Time frame: Up to 9 weeks

    Tmax = time to Cmax

  6. Secondary PK parameter: t½

    Time frame: Up to 9 weeks

    t½ = half-life

  7. Incidence of AEs, SAEs, and AEs leading to efgartigimod discontinuation

    Time frame: Up to 9 weeks

    AE = adverse event ; SAE = serious adverse event

Study contacts

Contact information is provided by the study sponsor or research team.

Sabine Coppieters, MD

CONTACT

[email protected]

857-350-4834

Sponsors and collaborators

Lead sponsor

argenx

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 24, 2026
Registry last updated
Aug 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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