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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Bioequivalence

Intervention / Treatment
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* Biological: efgartigimod PH20 SC as a prefilled syringe presentation
* Biological: efgartigimod PH20 SC as a vial + syringe presentation


Participation Criteria
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Eligibility Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Efgartigimod PH20 SC - prefilled syringe<br>efgartigimod PH20 SC administered by a prefilled syringe | Biological: efgartigimod PH20 SC as a prefilled syringe presentation<br>* efgartigimod PH20 SC as a prefilled syringe presentation<br>|
| Active Comparator: Efgartigimod PH20 SC - vial + syringe<br>efgartigimod PH20 SC administered by a vial + syringe | Biological: efgartigimod PH20 SC as a vial + syringe presentation<br>* efgartigimod PH20 SC as a vial + syringe presentation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary PK parameters (Cmax) | maximum observed plasma concentration | Up to 29 days | 
| Primary PK parameters (AUC0-inf) | area under the concentration-time curve from 0 to infinity | Up to 29 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total IgG as percent change from baseline over time |  | up to 57 days | 
| Total IgG as absolute change from baseline over time |  | up to 57 days | 
| Safety parameters (number of AEs) |  | up to 85 days | 
| Incidence of ADA against efgartigimod PH20 SC | Incidence of antidrug antibodies against efgartigimod PH20 SC | up to 57 days | 
| Second PK parameters (Tmax) | time to maximum concentration | up to 57 days | 
| Second PK parameters (AUC0-t) | area under the concentration-time curve from 0 to last quantifiable concentration | up to 57 days | 
| Second PK parameters (AUC0-168h) | area under the concentration-time curve from time 0 to168 hours | up to 57 days | 
| Second PK parameters (t1/2) | elimination half-life | up to 57 days | 
| Second PK parameters (Vz/F) | apparent volume of distribution | up to 57 days | 
| Second PK parameters (CL/F) | apparent clearance (total body clearance for extravascular administration divided by the fraction of dose absorbed, calculated using the observed value of the last nonzero concentration) | up to 57 days |