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Monoclonal Antibodies

Efgartigimod PH20 SC - prefilled syringe for Bioequivalence

Phase 1
Waitlist Available
Research Sponsored by argenx
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 57 days
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing how a drug called efgartigimod behaves in the blood when given to healthy people. The drug is given either through a prefilled syringe or a vial and syringe to see if there is any difference in how it is processed by the body.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 57 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 57 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Primary PK parameters (AUC0-inf)
Primary PK parameters (Cmax)
Secondary study objectives
Incidence of ADA against efgartigimod PH20 SC
Second PK parameters (AUC0-168h)
Second PK parameters (AUC0-t)
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Efgartigimod PH20 SC - prefilled syringeExperimental Treatment1 Intervention
efgartigimod PH20 SC administered by a prefilled syringe
Group II: Efgartigimod PH20 SC - vial + syringeActive Control1 Intervention
efgartigimod PH20 SC administered by a vial + syringe
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
efgartigimod PH20 SC as a prefilled syringe presentation
2023
Completed Phase 1
~120

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

argenxLead Sponsor
71 Previous Clinical Trials
10,960 Total Patients Enrolled
~45 spots leftby Nov 2025
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