Recruiting
Phase 1

Efgartigimod

Sponsor:

argenx

Code:

NCT07782775

Conditions

Healthy Volunteer

Healthy Adult Participants

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

Efgartigimod PH20 SC via PFS

Efgartigimod PH20 SC via AI

Study Details

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

Study ID

NCT07782775

Start date

Jun 19, 2026

Status verified date

Aug, 2026

Completion date

Sep 18, 2026

Anticipated

Primary completion date

Sep 18, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

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 Design

Enrollment

32 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

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

Interventions

Efgartigimod PH20 SC via PFS

Subcutaneous injection of empasiprubart via Prefilled syringe (PFS)

Efgartigimod PH20 SC via AI

Subcutaneous injection of empasiprubart via Autoinjector (AI)

Primary outcome measure

  • Primary PK parameter: Cmax [ Time Frame: Up to 9 weeks ]
  • Primary PK parameter: AUC0-inf [ Time Frame: Up to 9 weeks ]

Central Contacts and Locations

Central contacts

Sabine Coppieters, MD

857-350-4834clinicaltrials@argenx.com

Locations

Altasciences

Recruiting

Montreal, Canada, H3P 3P1

Contacts

Gaetano Morelli, MD

514-381-2546gamorelli@altasciences.com

More Information

Sponsor

argenx

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by argenx on 2026-08-24.