Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2025-12-30 @ 2:12 AM
Study NCT ID:
NCT06732804
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-24
First Post:
2024-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Investigate Comparative Pharmacokinetics, Safety, Immunogenicity and Tolerability Between AVT80 and Entyvio
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Poland']}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 351}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-19', 'studyFirstSubmitDate': '2024-12-10', 'studyFirstSubmitQcDate': '2024-12-12', 'lastUpdatePostDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To demonstrate PK similarity of AVT80 with geographical region 1 Entyvio and geographical region 2 Entyvio and between geographical region 1 Entyvio and geographical region 2 Entyvio', 'timeFrame': 'Day Zero to Day 126', 'description': 'PK endpoint of Cmax.'}, {'measure': 'To demonstrate PK similarity of AVT80 with geographical region 1 Entyvio and geographical region 2 Entyvio and between geographical region 1 Entyvio and geographical region 2 Entyvio', 'timeFrame': 'Day Zero to Day 126', 'description': 'PK endpoint of AUC0-inf.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pharmacokinetics'], 'conditions': ['Healthy Male and Female Subjects']}, 'descriptionModule': {'briefSummary': 'The study has been designed as a randomised, parallel-group, double-blind, 3 arm study to investigate the comparative pharmacokinetics, safety, immunogenicity and tolerability between AVT80 and Entyvio in healthy volunteers.', 'detailedDescription': 'The study will consist of a screening period, a treatment and assessment period and an End of Study visit. Eligibility for the study will be determined during a screening period. Subjects who meet the eligibility criteria will be randomised to receive a single dose of either AVT80, geographical region 1 Entyvio or geographical region 2 Entyvio.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy male and female participant capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and in the protocol.\n* Have a body weight of 50.0 to 90.0 kg (inclusive) and body mass index (BMI) of 17.0 to 32.0 kg/m2 (inclusive).\n* Participant must be 18 to 55 years old inclusive, at the time of signing the ICF.\n\nExclusion Criteria:\n\n* Participant has a history of relevant drug and/or food allergies.\n* Participant has a history of hypersensitivity to Entyvio, AVT80, or their constituents.\n* Participant has any past or concurrent medical conditions that could potentially increase the participant's risks or that would interfere with the study evaluation, procedures, or study completion. Examples of these include medical history with evidence of clinically relevant pathology (e.g., demyelinating disorders)."}, 'identificationModule': {'nctId': 'NCT06732804', 'briefTitle': 'Study to Investigate Comparative Pharmacokinetics, Safety, Immunogenicity and Tolerability Between AVT80 and Entyvio', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alvotech Swiss AG'}, 'officialTitle': 'A Randomised, Parallel Group Treatment, Double-blind, 3-arm Study to Investigate the Comparative PK, Safety, Immunogenicity, and Tolerability Between AVT80 and Entyvio® in Healthy Male and Female Participants Aged 18 to 55 Years Inclusive', 'orgStudyIdInfo': {'id': 'AVT80-GL-P01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AVT80', 'description': 'Single subcutaneous administration of AVT80', 'interventionNames': ['Biological: AVT80']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Geographical region 1 Entyvio', 'description': 'Single subcutaneous administration of Geographical region 1 Entyvio', 'interventionNames': ['Biological: Geographical region 1 Entyvio']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Geographical region 2 Entyvio', 'description': 'Single subcutaneous administration of Geographical region 2 Entyvio', 'interventionNames': ['Biological: Geographical region 2 Entyvio']}], 'interventions': [{'name': 'AVT80', 'type': 'BIOLOGICAL', 'description': 'Single subcutaneous injection of AVT80 (108mg)', 'armGroupLabels': ['AVT80']}, {'name': 'Geographical region 1 Entyvio', 'type': 'BIOLOGICAL', 'description': 'Single subcutaneous injection of Geographical region 1 Entyvio (108mg)', 'armGroupLabels': ['Geographical region 1 Entyvio']}, {'name': 'Geographical region 2 Entyvio', 'type': 'BIOLOGICAL', 'description': 'Single subcutaneous injection of Geographical region 2 Entyvio (108mg)', 'armGroupLabels': ['Geographical region 2 Entyvio']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bayswater', 'country': 'Australia', 'facility': 'Veritus Research Pty Ltd', 'geoPoint': {'lat': -31.91686, 'lon': 115.91776}}, {'city': 'Auckland', 'country': 'New Zealand', 'facility': 'Investigational Site 0002', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}, {'zip': '8011', 'city': 'Christchurch', 'country': 'New Zealand', 'facility': 'NZCR', 'geoPoint': {'lat': -43.53333, 'lon': 172.63333}}], 'overallOfficials': [{'name': 'Eveline Schurink', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alvotech Swiss AG'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alvotech Swiss AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}