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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Efgartigimod PH20 SC - prefilled syringe | Experimental | efgartigimod PH20 SC administered by a prefilled syringe |
|
| Efgartigimod PH20 SC - vial + syringe | Active Comparator | efgartigimod PH20 SC administered by a vial + syringe |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| efgartigimod PH20 SC as a prefilled syringe presentation | Biological | efgartigimod PH20 SC as a prefilled syringe presentation |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigator site 0010209 | Tempe | Arizona | 85282 | United States | ||
| Investigator site 0010208 |
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| efgartigimod PH20 SC as a vial + syringe presentation | Biological | efgartigimod PH20 SC as a vial + syringe presentation |
|
| 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 |
| Lincoln |
| Nebraska |
| 68510 |
| United States |