Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2025-12-28 @ 6:25 AM
Study NCT ID:
NCT05817435
Status:
COMPLETED
Last Update Posted:
2023-10-31
First Post:
2023-04-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1 Bioequivalence Study of Efgartigimod PH20 SC Administered Via a Prefilled Syringe Versus a Vial+Syringe Presentation in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-05-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-30', 'studyFirstSubmitDate': '2023-04-05', 'studyFirstSubmitQcDate': '2023-04-05', 'lastUpdatePostDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary PK parameters (Cmax)', 'timeFrame': 'Up to 29 days', 'description': 'maximum observed plasma concentration'}, {'measure': 'Primary PK parameters (AUC0-inf)', 'timeFrame': 'Up to 29 days', 'description': 'area under the concentration-time curve from 0 to infinity'}], 'secondaryOutcomes': [{'measure': 'Total IgG as percent change from baseline over time', 'timeFrame': 'up to 57 days'}, {'measure': 'Total IgG as absolute change from baseline over time', 'timeFrame': 'up to 57 days'}, {'measure': 'Safety parameters (number of AEs)', 'timeFrame': 'up to 85 days'}, {'measure': 'Incidence of ADA against efgartigimod PH20 SC', 'timeFrame': 'up to 57 days', 'description': 'Incidence of antidrug antibodies against efgartigimod PH20 SC'}, {'measure': 'Second PK parameters (Tmax)', 'timeFrame': 'up to 57 days', 'description': 'time to maximum concentration'}, {'measure': 'Second PK parameters (AUC0-t)', 'timeFrame': 'up to 57 days', 'description': 'area under the concentration-time curve from 0 to last quantifiable concentration'}, {'measure': 'Second PK parameters (AUC0-168h)', 'timeFrame': 'up to 57 days', 'description': 'area under the concentration-time curve from time 0 to168 hours'}, {'measure': 'Second PK parameters (t1/2)', 'timeFrame': 'up to 57 days', 'description': 'elimination half-life'}, {'measure': 'Second PK parameters (Vz/F)', 'timeFrame': 'up to 57 days', 'description': 'apparent volume of distribution'}, {'measure': 'Second PK parameters (CL/F)', 'timeFrame': 'up to 57 days', 'description': '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)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bioequivalence']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Is at least the local legal age of consent for participation in a clinical study and ≤55 years when signing the ICF\n* Is capable of providing signed informed consent, and complying with protocol requirements\n* 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.\n* Has a BMI between 18 and 30 kg/m2 , inclusive, and a weight between 50 and 100 kg (inclusive) at screening\n\nExclusion Criteria:\n\n* 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\n* 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.\n* Has a clinically significant active infection that is not sufficiently resolved in the investigator's opinion.\n* 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).\n* 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.\n* Received a different IMP in another clinical study \\<12 weeks or 5 half-lives (whichever is longer) before screening.\n* Is currently participating in another interventional clinical study. Has a known hypersensitivity to IMP or its excipients.\n* 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.\n* Has a history of (within 12 months before screening) or current alcohol, drug, or medication abuse, as assessed by the investigator.\n* Is pregnant or lactating or intends to become pregnant during the study.\n* Previously participated in an efgartigimod clinical study and received at least 1 dose of IMP.\n* Is taking concomitant medications (except for oral contraceptives or occasional acetaminophen).\n* Has a total IgG of \\<4 g/L at screening.\n* 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."}, 'identificationModule': {'nctId': 'NCT05817435', 'briefTitle': 'A Phase 1 Bioequivalence Study of Efgartigimod PH20 SC Administered Via a Prefilled Syringe Versus a Vial+Syringe Presentation in Healthy Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'argenx'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'ARGX-113-2204'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Efgartigimod PH20 SC - prefilled syringe', 'description': 'efgartigimod PH20 SC administered by a prefilled syringe', 'interventionNames': ['Biological: efgartigimod PH20 SC as a prefilled syringe presentation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Efgartigimod PH20 SC - vial + syringe', 'description': 'efgartigimod PH20 SC administered by a vial + syringe', 'interventionNames': ['Biological: efgartigimod PH20 SC as a vial + syringe presentation']}], 'interventions': [{'name': 'efgartigimod PH20 SC as a prefilled syringe presentation', 'type': 'BIOLOGICAL', 'description': 'efgartigimod PH20 SC as a prefilled syringe presentation', 'armGroupLabels': ['Efgartigimod PH20 SC - prefilled syringe']}, {'name': 'efgartigimod PH20 SC as a vial + syringe presentation', 'type': 'BIOLOGICAL', 'description': 'efgartigimod PH20 SC as a vial + syringe presentation', 'armGroupLabels': ['Efgartigimod PH20 SC - vial + syringe']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85282', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigator site 0010209', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}, {'zip': '68510', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Investigator site 0010208', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'argenx', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}