A Phase 1, Randomized, Open-label, Parallel-Group, Single-Dose, Bioequivalence Study of Efgartigimod PH20 SC Administered Via a Prefilled Syringe Versus a Vial + Syringe Presentation in Healthy Adults

argenx2 sites in 1 country120 target enrollmentMarch 13, 2023

ConditionsBioequivalence

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Bioequivalence
Sponsor: argenx
Enrollment: 120
Locations: 2
Primary Endpoint: Primary PK parameters (Cmax)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a randomized, open-label, parallel-group, single-dose study comparing the pharmacokinetics of efgartigimod in blood following a single administration of efgartigimod PH20 SC via a prefilled syringe versus a vial + syringe in healthy participants.

Registry

clinicaltrials.gov

Start Date

March 13, 2023

End Date

May 12, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

argenx

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Is at least the local legal age of consent for participation in a clinical study and ≤55 years when signing the ICF
•Is capable of providing signed informed consent, and complying with protocol requirements
•Agrees to use contraceptive measures consistent with local regulations and the following: Women Of Child-Bearing Potential must have a negative serum hCG pregnancy test at screening and a negative urine hCG pregnancy test at baseline before receiving IMP.
•Has a BMI between 18 and 30 kg/m2 , inclusive, and a weight between 50 and 100 kg (inclusive) at screening

Exclusion Criteria

•Has a known autoimmune disease or any medical condition that, in the investigator's judgment, would interfere with an accurate assessment of clinical symptoms or puts the participant at undue risk
•Has a history of malignancy, unless considered cured by adequate treatment with no evidence of recurrence for ≥3 years before the administration of IMP. Adequately-treated participants with the following cancers can be included at any time: Basal cell or squamous cell skin cancer; Carcinoma in situ of the cervix; Carcinoma in situ of the breast; Incidental histological findings of prostate cancer.
•Has a clinically significant active infection that is not sufficiently resolved in the investigator's opinion.
•Has a positive serum test at screening for active infection with any of the following: HBV indicative of an acute or chronic infection, unless associated with a negative HBsAg or negative HBV DNA test; HCV based on HCV antibody assay unless a negative RNA test is available ; HIV based on test results (regardless of therapy treatment or not).
•Has a clinically significant disease, recent major surgery (within 3 months of screening), or intends to have surgery during the study; or any other medical condition that, in the investigator's opinion, would confound the results of the study or put the participant at undue risk.
•Received a different IMP in another clinical study \<12 weeks or 5 half-lives (whichever is longer) before screening.
•Is currently participating in another interventional clinical study. Has a known hypersensitivity to IMP or its excipients.
•Has abdominal skin condition that does not allow for absorption and assessment of local safety of the planned SC injection, as determined by the investigator.
•Has a history of (within 12 months before screening) or current alcohol, drug, or medication abuse, as assessed by the investigator.
•Is pregnant or lactating or intends to become pregnant during the study.