Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-25 @ 9:44 PM
Study NCT ID:
NCT05885451
Status:
COMPLETED
Last Update Posted:
2023-06-02
First Post:
2023-05-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of AMG 592 in Healthy Japanese Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092122', 'term': 'Bronchiolitis Obliterans Syndrome'}], 'ancestors': [{'id': 'D000092124', 'term': 'Organizing Pneumonia'}, {'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}, {'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2019-04-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-23', 'studyFirstSubmitDate': '2023-05-23', 'studyFirstSubmitQcDate': '2023-05-23', 'lastUpdatePostDateStruct': {'date': '2023-06-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Observed Serum Concentration (Cmax) of AMG 592', 'timeFrame': 'Up to Day 43'}, {'measure': 'Time of Maximum Observed Concentration (tmax) of AMG 592', 'timeFrame': 'Up to Day 43'}, {'measure': 'Area Under the Serum Concentration-time Curve to the Last Measurable Point (AUClast) of AMG 592', 'timeFrame': 'Up to Day 43'}, {'measure': 'Area Under the Concentration-time Curve (AUC) from Time Zero to Infinity (AUCinf)', 'timeFrame': 'Up to Day 43'}], 'secondaryOutcomes': [{'measure': 'Number of Participants who Experience Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'Day 1 to Day 43'}, {'measure': 'Number of Participants who Experience Anti-AMG 592 Antibodies Formation', 'timeFrame': 'Up to Day 43'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Graft-versus-Host Disease', 'AMG 592', 'Inflammatory Conditions'], 'conditions': ['Chronic Graft-versus-Host Disease (cGVHD)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to characterize the pharmacokinetics (PK) profile of a single dose of AMG 592 administered subcutaneously in healthy Japanese participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant must be first generation Japanese (4 grandparents, biologic parents, and subject born in Japan and of Japanese heritage)\n* Male and female participants must be ≥ 18 and ≤ 55 years of age with a body mass index (BMI) of ≥ 18.5 and ≤ 25.0 kg/m\\^2 at the time of screening\n\nExclusion Criteria:\n\n* Participant with history of prior malignancy within the last 5 years except malignancy (in situ) fully excised or treated with curative intent and with no known active disease present for ≥3 years before enrollment and felt to be at low risk for recurrence by the treating physician, non-melanoma skin cancers, cervical or breast ductal carcinoma in situ\n* Participants with a known history of autoimmune disease\n* Participants who have donated or lost ≥ 500 mL of blood or plasma within 8 weeks of administration of the first dose of IP\n* Participants with any active infection for which systemic anti-infectives were used within 4 weeks prior to Day 1\n* Positive for Hepatitis B surface antigen (HBsAg) (indicative of chronic hepatitis B or recent acute hepatitis B)\n* Participant has positive test results for Human Immunodeficiency Virus (HIV)\n* Participant has a positive test for tuberculosis during screening defined as either a positive purified derivative (PPD) (\\>= 5 mm of induration at 48 to 72 hours after test is placed) OR a positive QuantiFERON test'}, 'identificationModule': {'nctId': 'NCT05885451', 'briefTitle': 'A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of AMG 592 in Healthy Japanese Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Phase I, Double Blind, Placebo-controlled, Randomized, Parallel, Single Ascending Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of AMG 592 Administered Subcutaneously in Healthy Japanese Subjects', 'orgStudyIdInfo': {'id': '20180132'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1: AMG 592 Dose 1', 'description': 'Participants will receive AMG 592 dose 1 subcutaneously', 'interventionNames': ['Drug: AMG 592']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2: AMG 592 Dose 2', 'description': 'Participants will receive AMG 592 dose 2 subcutaneously', 'interventionNames': ['Drug: AMG 592']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 3: Placebo', 'description': 'Participants will receive placebo subcutaneously', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'AMG 592', 'type': 'DRUG', 'description': 'Administered as SC injection', 'armGroupLabels': ['Arm 1: AMG 592 Dose 1', 'Arm 2: AMG 592 Dose 2']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Administered as SC injection', 'armGroupLabels': ['Arm 3: Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2031', 'city': 'Randwick', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Research Site', 'geoPoint': {'lat': -33.91439, 'lon': 151.24895}}], 'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'ipdSharingStatementModule': {'url': 'http://www.amgen.com/datasharing', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.', 'ipdSharing': 'YES', 'description': 'De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.', 'accessCriteria': 'Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}