Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2025-12-25 @ 2:26 PM
Study NCT ID:
NCT07214766
Status:
RECRUITING
Last Update Posted:
2025-12-04
First Post:
2025-10-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Assess the Bioequivalence of Trastuzumab Via Different Subcutaneous Delivery Platforms in Healthy Male Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068878', 'term': 'Trastuzumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 312}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-04-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2025-10-06', 'studyFirstSubmitQcDate': '2025-10-06', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-04-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part 1: Area Under the Concentration-Time Curve from Hour 0 to 21 days Postdose (AUC0-21days) of Trastuzumab', 'timeFrame': 'Up to Day 57'}, {'measure': 'Part 1: Maximum Observed Concentration (Cmax) of Trastuzumab', 'timeFrame': 'Up to Day 57'}, {'measure': 'Part 2: AUC0-21days of Trastuzumab', 'timeFrame': 'Up to Day 57'}, {'measure': 'Part 2: Cmax of Trastuzumab', 'timeFrame': 'Up to Day 57'}, {'measure': 'Percentage of Participants with Adverse Events (AEs)', 'timeFrame': 'Up to Day 57'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Participants']}, 'descriptionModule': {'briefSummary': 'This two-part study will evaluate the bioequivalence, safety, and tolerability of a single SC dose of trastuzumab administered via handheld syringe/syringe pump (HHS/SP) with infusion set (IS) and an on-body delivery system (OBDS).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Within body mass index (BMI) range 18 to 38 kilogram per meter square (kg/m2), inclusive. Body weight \\<=100 kg\n* Left ventricular ejection fraction (LVEF) \\>= 55 percent (%) measured by echocardiogram (ECHO)\n* Negative test result for drugs of abuse\n* Negative test result for hepatitis B surface antigen, hepatitis C virus (HCV), or human immunodeficiency virus (HIV) antibody screen\n* Negative test for latent Tuberculosis (TB) infection by QuantiFERON® TB Gold\n* Agree to use contraception and will refrain from sperm donation\n\nExclusion Criteria:\n\n* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, respiratory, gastrointestinal, immunological, neurological, or psychiatric disorder; acute infection; or other unstable medical disease\n* History of moderate or severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins\n* Known sensitivity to recombinant hyaluronidase or other form of hyaluronidase\n* History or presence of atrial fibrillation\n* History of any clinically significant or clinically relevant cardiac condition\n* History or presence of clinically significant electrocardiogram (ECG) abnormalities\n* History of uncontrolled hypertension, hyperlipidemia, thyroid disorder, or diabetes\n* Family history of clinically significant and clinically relevant hypersensitivity, allergy, or severe cardiac diseases\n* History of previous anti-cancer treatments including pertuzumab, trastuzumab, anthracyclines, or any cardiotoxic drugs\n* History of active or latent TB, regardless of treatment history\n* Poor peripheral venous access\n* History or presence of any malignancy, with the exception of completely excised basal cell or squamous cell carcinoma of the skin'}, 'identificationModule': {'nctId': 'NCT07214766', 'briefTitle': 'A Study to Assess the Bioequivalence of Trastuzumab Via Different Subcutaneous Delivery Platforms in Healthy Male Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genentech, Inc.'}, 'officialTitle': 'A Phase 1, Randomized, Two-Part, Parallel-Group Study to Assess the Bioequivalence of Subcutaneously Administered Trastuzumab Via Different Subcutaneous Delivery Platforms in Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'GP44770'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1', 'description': 'Participants will receive formulation 1 of trastuzumab SC via OBDS or HHS/SP with IS.', 'interventionNames': ['Drug: Trastuzumab']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2', 'description': 'Participants will receive formulation 2 of trastuzumab SC via OBDS or HHS/SP with IS.', 'interventionNames': ['Drug: Trastuzumab']}], 'interventions': [{'name': 'Trastuzumab', 'type': 'DRUG', 'description': 'Trastuzumab will be administered to participants as a solution for injection.', 'armGroupLabels': ['Part 1', 'Part 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Anaheim Clinical Trials', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '32117', 'city': 'Daytona Beach', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Daytona Beach Clinical Rsch Unit', 'geoPoint': {'lat': 29.21081, 'lon': -81.02283}}, {'zip': '65802-4842', 'city': 'Springfield', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'QPS Bio-Kinetic', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '75247', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Fortrea Clinical Research Unit - Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'centralContacts': [{'name': 'Reference Study ID Number: GP44770 https://forpatients.roche.com/', 'role': 'CONTACT', 'email': 'global-roche-genentech-trials@gene.com', 'phone': '888-662-6728 (U.S. and Canada)'}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Genentech, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}