Bioequivalence
Conditions
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.
Interventions
BIOLOGICALefgartigimod PH20 SC as a prefilled syringe presentation
efgartigimod PH20 SC as a prefilled syringe presentation
BIOLOGICALefgartigimod PH20 SC as a vial + syringe presentation
efgartigimod PH20 SC as a vial + syringe presentation
Sponsors
argenx
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary PK parameters (Cmax) | Up to 29 days | maximum observed plasma concentration |
| Primary PK parameters (AUC0-inf) | Up to 29 days | area under the concentration-time curve from 0 to infinity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety parameters (number of AEs) | up to 85 days | — |
| Incidence of ADA against efgartigimod PH20 SC | up to 57 days | Incidence of antidrug antibodies against efgartigimod PH20 SC |
| Second PK parameters (Tmax) | up to 57 days | time to maximum concentration |
| Second PK parameters (AUC0-t) | up to 57 days | area under the concentration-time curve from 0 to last quantifiable concentration |
| Total IgG as percent change from baseline over time | up to 57 days | — |
| Second PK parameters (t1/2) | up to 57 days | elimination half-life |
| Second PK parameters (Vz/F) | up to 57 days | apparent volume of distribution |
| Second PK parameters (CL/F) | up to 57 days | 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) |
| Second PK parameters (AUC0-168h) | up to 57 days | area under the concentration-time curve from time 0 to168 hours |
| Total IgG as absolute change from baseline over time | up to 57 days | — |
Countries
United States
Outcome results
None listed