NCT07782775 A Study to Assess the Bioequivalence of Efgartigimod PH20 SC Between Autoinjector and Prefilled Syringe in Healthy Adult Participants
| NCT ID | NCT07782775 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | argenx |
| Condition | Healthy Volunteer |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2026-06-19 |
| Primary Completion | 2026-09-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 32 participants in total. It began in 2026-06-19 with a primary completion date of 2026-09-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07782775 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Healthy Volunteer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07782775 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07782775 currently recruiting?
Yes, NCT07782775 is actively recruiting participants. Contact the research team at clinicaltrials@argenx.com for enrollment information.
Where is the NCT07782775 trial being conducted?
This trial is being conducted at Montreal, Canada.
Who is sponsoring the NCT07782775 clinical trial?
NCT07782775 is sponsored by argenx. The trial plans to enroll 32 participants.