[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653128":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":38,"studyPopulation":38,"armGroups":45,"interventions":57,"overallOfficials":38,"centralContacts":67,"locations":73,"responsibleParty":92,"collaborators":38,"id":94,"slug":95,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":38,"eligibilityCriteria":100,"healthyVolunteers":101,"sex":102,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":38,"studyType":108,"phases":109,"briefSummary":111,"conditions":112,"keywords":38,"overallStatus":76,"whyStopped":38,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"argenx","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":38},[9,13],{"measure":10,"description":11,"timeFrame":12},"Primary PK parameter: Cmax","Cmax = maximum observed concentration","Up to 9 weeks",{"measure":14,"description":15,"timeFrame":12},"Primary PK parameter: AUC0-inf","AUC0-inf = area under the curve from time 0 to infinity",[17,20,23,26,29,32,35],{"measure":18,"description":19,"timeFrame":12},"Secondary PK parameter: AUC0-t","AUC0-t = area under the curve from time 0 to the last measurable time point",{"measure":21,"description":22,"timeFrame":12},"Secondary PK parameter: AUC0-168h","AUC0-168h = area under the curve from time 0 to 168 hours",{"measure":24,"description":25,"timeFrame":12},"Secondary PK parameter: CL\u002FF","CL\u002FF = apparent clearance from plasma after extravascular administration",{"measure":27,"description":28,"timeFrame":12},"Secondary PK parameter: Vz\u002FF","Vz\u002FF = apparent volume of distribution at steady state after extravascular administration",{"measure":30,"description":31,"timeFrame":12},"Secondary PK parameter: Tmax","Tmax = time to Cmax",{"measure":33,"description":34,"timeFrame":12},"Secondary PK parameter: t½","t½ = half-life",{"measure":36,"description":37,"timeFrame":12},"Incidence of AEs, SAEs, and AEs leading to efgartigimod discontinuation","AE = adverse event ; SAE = serious adverse event",null,{"allocation":40,"interventionModel":41,"interventionModelDescription":38,"primaryPurpose":42,"observationalModel":38,"timePerspective":38,"maskingInfo":43},"RANDOMIZED","CROSSOVER","TREATMENT",{"masking":44,"maskingDescription":38,"whoMasked":38},"NONE",[46,53],{"label":47,"type":48,"description":49,"interventionNames":50},"Treatment sequence 1","EXPERIMENTAL","Participants randomized to receive Efgartigimod PH20 SC via AI in period 1 and Efgartigimod PH20 SC via PFS in period 2",[51,52],"Biological: Efgartigimod PH20 SC via PFS","Biological: Efgartigimod PH20 SC via AI",{"label":54,"type":48,"description":55,"interventionNames":56},"Treatment sequence 2","Participants randomized to receive Efgartigimod PH20 SC via PFS in period 1 and Efgartigimod PH20 SC via AI in period 2",[51,52],[58,63],{"type":59,"name":60,"description":61,"armGroupLabels":62,"otherNames":38},"BIOLOGICAL","Efgartigimod PH20 SC via PFS","Subcutaneous injection of empasiprubart via Prefilled syringe (PFS)",[47,54],{"type":59,"name":64,"description":65,"armGroupLabels":66,"otherNames":38},"Efgartigimod PH20 SC via AI","Subcutaneous injection of empasiprubart via Autoinjector (AI)",[47,54],[68],{"name":69,"role":70,"phone":71,"phoneExt":38,"email":72},"Sabine Coppieters, MD","CONTACT","857-350-4834","clinicaltrials@argenx.com",[74],{"facility":75,"status":76,"city":77,"state":38,"zip":78,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":86,"contacts":87},"Altasciences","RECRUITING","Montreal","H3P 3P1","Canada","CA",{"type":82,"coordinates":83},"Point",[84,85],-73.58781,45.50884,{"lat":85,"lon":84},[88],{"name":89,"role":70,"phone":90,"phoneExt":38,"email":91},"Gaetano Morelli, MD","514-381-2546","gamorelli@altasciences.com",{"type":93,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR","100653128","phase-1-a-study-to-assess-the-bioequivalence-of-efgartigimod-ph20-sc-between-autoinjector-and-prefilled-syringe-in-healthy-adult-participants-100653128",false,"NCT07782775","A Study to Assess the Bioequivalence of Efgartigimod PH20 SC Between Autoinjector and Prefilled Syringe in Healthy Adult Participants","A Phase 1, Open-Label, Randomized, Single-Dose, 2-Period Crossover, Bioequivalence Study of Efgartigimod PH20 SC Administered Via Autoinjector Versus Prefilled Syringe in Healthy Adult Participants","Inclusion Criteria:\n\n* Is at least the local legal age of consent and aged 18 to 55 years, inclusive, when signing the ICF.\n* Has a body weight between 50 and 100 kg and a BMI between 18 and 30 kg\u002Fm2, inclusive.\n\nExclusion Criteria:\n\n* Has any current or past clinically meaningful medical or psychiatric condition that, in the investigator's opinion, would confound the study results or put the participant at undue risk.\n* Has received any medications, including nonprescription and prescription medications, within 2 weeks before the first IMP administration, except for hormonal contraceptives and hormone replacement therapy in female participants. The occasional use of acetaminophen or ibuprofen is allowed.\n* Previously participated in an efgartigimod clinical study and received at least 1 dose of IMP.",true,"ALL","18 Years","55 Years",{"count":106,"type":107},32,"ESTIMATED","INTERVENTIONAL",[110],"PHASE1","The aim of this study is to compare the amount of efgartigimod in the blood over time after it is injected via Prefilled syringe (PFS) and Autoinjector (AI).\n\nThe study will comprise 2 study periods of 3 weeks each. Each participant receives both efgartigimod PH20 SC AI and PFS treatments, in a different order.\n\nParticipants will be in the study for up to approximately 9 weeks.",[113,114],"Healthy Volunteer","Healthy Adult Participants","2026-08-20",{"date":117,"type":118},"2026-08-24","ACTUAL",{"date":120,"type":118},"2026-06-19",{"date":122,"type":107},"2026-09-18",{"name":5,"class":6},1]