A Phase 1 Bioequivalence Study of Efgartigimod PH20 SC Administered Via a Prefilled Syringe Versus a Vial+Syringe Presentation in Healthy Adults

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.
• •Previously participated in an efgartigimod clinical study and received at least 1 dose of IMP.
• •Is taking concomitant medications (except for oral contraceptives or occasional acetaminophen).
• •Has a total IgG of \<4 g/L at screening.
• •Had a positive COVID-19 test result on day -1 or contact with someone with a known COVID-19 infection within 2 weeks before receiving IMP.