{"protocolSection":{"identificationModule":{"nctId":"NCT05056246","orgStudyIdInfo":{"id":"20200290"},"organization":{"fullName":"Amgen","class":"INDUSTRY"},"briefTitle":"Study of AMG 133 Administered Subcutaneously in Healthy Japanese and Caucasian Participants","officialTitle":"A Phase I, Open-label, Randomized, Parallel-arm, Single-dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AMG 133 Administered Subcutaneously in Healthy Japanese and Caucasian Subjects"},"statusModule":{"statusVerifiedDate":"2025-01","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2021-09-10","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2022-04-08","type":"ACTUAL"},"completionDateStruct":{"date":"2022-04-08","type":"ACTUAL"},"studyFirstSubmitDate":"2021-09-15","studyFirstSubmitQcDate":"2021-09-15","studyFirstPostDateStruct":{"date":"2021-09-24","type":"ACTUAL"},"resultsFirstSubmitDate":"2025-02-04","resultsFirstSubmitQcDate":"2025-02-04","resultsFirstPostDateStruct":{"date":"2025-02-25","type":"ACTUAL"},"lastUpdateSubmitDate":"2025-02-04","lastUpdatePostDateStruct":{"date":"2025-02-25","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Amgen","class":"INDUSTRY"}},"oversightModule":{"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"The primary objective of this study is to evaluate the pharmacokinetics (PK) of AMG 133 after single subcutaneous (SC) administration in healthy Japanese and Caucasian participants."},"conditionsModule":{"conditions":["Healthy Participants"],"keywords":["Maridebart Cafraglutide","Japanese participants","Caucasian participants","AMG 133"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE1"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"BASIC_SCIENCE","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":34,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Japanese Participants: AMG 133 Low Dose","type":"EXPERIMENTAL","description":"Healthy Japanese participants will receive the low dose of AMG 133 as a SC injection on Day 1 of the study.","interventionNames":["Drug: AMG 133"]},{"label":"Japanese Participants: AMG 133 Medium Dose","type":"EXPERIMENTAL","description":"Healthy Japanese participants will receive the medium dose of AMG 133 as a SC injection on Day 1 of the study.","interventionNames":["Drug: AMG 133"]},{"label":"Japanese Participants: AMG 133 High Dose","type":"EXPERIMENTAL","description":"Healthy Japanese participants will receive the high dose of AMG 133 as a SC injection on Day 1 of the study.","interventionNames":["Drug: AMG 133"]},{"label":"Caucasian Participants: AMG 133 Medium Dose","type":"EXPERIMENTAL","description":"Healthy Caucasian participants will receive the medium dose of AMG 133 as a SC injection on Day 1 of the study.","interventionNames":["Drug: AMG 133"]},{"label":"Caucasian Participants: AMG 133 High Dose","type":"EXPERIMENTAL","description":"Healthy Caucasian participants will receive the high dose of AMG 133 as a SC injection on Day 1 of the study.","interventionNames":["Drug: AMG 133"]}],"interventions":[{"type":"DRUG","name":"AMG 133","description":"Solution for SC injection","armGroupLabels":["Caucasian Participants: AMG 133 High Dose","Caucasian Participants: AMG 133 Medium Dose","Japanese Participants: AMG 133 High Dose","Japanese Participants: AMG 133 Low Dose","Japanese Participants: AMG 133 Medium Dose"],"otherNames":["maridebart cafraglutide"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Maximum Observed Plasma Concentration (Cmax) of Intact AMG 133","description":"Blood samples were collected at specific times during the study for the measurement of plasma concentrations of intact and total AMG 133 by a laboratory.","timeFrame":"Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose"},{"measure":"Cmax of Total AMG 133","description":"Blood samples were collected at specific times during the study for the measurement of plasma concentrations of intact and total AMG 133 by a laboratory.","timeFrame":"Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose"},{"measure":"Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of Intact AMG 133","description":"Blood samples were collected at specific times during the study for the measurement of plasma concentrations of intact and total AMG 133 by a laboratory.","timeFrame":"Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose"},{"measure":"AUClast of Total AMG 133","description":"Blood samples were collected at specific times during the study for the measurement of plasma concentrations of intact and total AMG 133 by a laboratory.","timeFrame":"Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose"},{"measure":"Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf) of Intact AMG 133","description":"Blood samples were collected at specific times during the study for the measurement of plasma concentrations of intact and total AMG 133 by a laboratory.","timeFrame":"Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose"},{"measure":"AUCinf of Total AMG 133","description":"Blood samples were collected at specific times during the study for the measurement of plasma concentrations of intact and total AMG 133 by a laboratory.","timeFrame":"Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose"}],"secondaryOutcomes":[{"measure":"Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)","description":"A TEAE was defined as any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with AMG 133 that started during or after dosing, or started prior to dosing and increased in severity after dosing.\n\nClinically significant changes from baseline in clinical laboratory tests, 12-lead electrocardiograms (ECGs) and vital signs were also reported as TEAEs.","timeFrame":"Day 1 to Day 120"},{"measure":"Number of Participants With a Positive Anti-AMG 133 Binding Antibody Result","description":"Blood samples were collected at specific times during the study for the measurement of anti-AMG 133 binding antibodies from participants who received AMG 133.","timeFrame":"Days 1, 15, 29, 57 and 120"}]},"eligibilityModule":{"eligibilityCriteria":"Key Inclusion Criteria:\n\n1. Healthy male or female participants between 18 and 65 years of age (inclusive) at the time of Screening (Japanese participants must be first-generation Japanese)\n2. In good health, determined by no clinically significant findings from medical history, physical examination, ECG, vital signs measurements, and clinical laboratory evaluations\n3. Body mass index between 18 and 30 kg/m\\^2 at the time of Screening\n4. Females of nonchildbearing potential\n\nKey Exclusion Criteria:\n\n1. History or evidence, at Screening or Check-in, of clinically significant disorder, condition, or disease\n2. History or current signs or symptoms of cardiovascular disease\n3. History or evidence of clinically significant arrhythmia at Screening, including any clinically significant findings on the ECG taken at Check-in\n4. History of hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance\n5. Positive hepatitis B or hepatitis C panel and/or positive human immunodeficiency virus test at Screening\n6. History of alcoholism or drug/chemical abuse within 1 year prior to Check-in\n7. Use of tobacco- or nicotine-containing products within 6 months prior to Check-in\n8. Positive test for illicit drugs, cotinine (tobacco or nicotine use), and/or alcohol use at Screening or Check-in\n9. Female participants with a positive pregnancy test at Screening or Check-in\n10. Female participants lactating/breastfeeding or who plans to breastfeed during the study through 90 days after the end of study (EOS) visit\n11. Donation of blood from 3 months prior to Check-in, plasma from 2 weeks prior to Check-in, or platelets from 6 weeks prior to Check-in\n12. Unwilling to abide with study restrictions","healthyVolunteers":true,"sex":"ALL","minimumAge":"18 Years","maximumAge":"65 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"MD","affiliation":"Amgen","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"WCCT Global LLC","city":"Cypress","state":"California","zip":"90630-4738","country":"United States","geoPoint":{"lat":33.81696,"lon":-118.03729}}]},"referencesModule":{"seeAlsoLinks":[{"label":"AmgenTrials clinical trials website","url":"http://www.amgentrials.com"}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request","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.","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.","url":"http://www.amgen.com/datasharing"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"A total of 34 participants were enrolled and randomized in the study. All 34 participants were dosed in accordance with the protocol.","recruitmentDetails":"Healthy Japanese and Caucasian participants were enrolled at a single center in the United States between 10 September 2021 and 08 April 2022.","groups":[{"id":"FG000","title":"Japanese Participants: AMG 133 Low Dose","description":"Healthy Japanese participants received the low dose of AMG 133 as a subcutaneous (SC) injection on Day 1 of the study."},{"id":"FG001","title":"Japanese Participants: AMG 133 Medium Dose","description":"Healthy Japanese participants received the medium dose of AMG 133 as a SC injection on Day 1 of the study."},{"id":"FG002","title":"Japanese Participants: AMG 133 High Dose","description":"Healthy Japanese participants received the high dose of AMG 133 as a SC injection on Day 1 of the study."},{"id":"FG003","title":"Caucasian Participants: AMG 133 Medium Dose","description":"Healthy Caucasian participants received the medium dose of AMG 133 as a SC injection on Day 1 of the study."},{"id":"FG004","title":"Caucasian Participants: AMG 133 High Dose","description":"Healthy Caucasian participants received the high dose of AMG 133 as a SC injection on Day 1 of the study."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"7"},{"groupId":"FG002","numSubjects":"7"},{"groupId":"FG003","numSubjects":"7"},{"groupId":"FG004","numSubjects":"7"}]},{"type":"Received AMG 133","achievements":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"7"},{"groupId":"FG002","numSubjects":"7"},{"groupId":"FG003","numSubjects":"7"},{"groupId":"FG004","numSubjects":"7"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"7"},{"groupId":"FG003","numSubjects":"5"},{"groupId":"FG004","numSubjects":"6"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"2"},{"groupId":"FG004","numSubjects":"1"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"1"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"2"},{"groupId":"FG004","numSubjects":"0"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Safety Population: Included all participants who received at least 1 dose of AMG 133.","groups":[{"id":"BG000","title":"Japanese Participants: AMG 133 Low Dose","description":"Healthy Japanese participants received the low dose of AMG 133 as a SC injection on Day 1 of the study."},{"id":"BG001","title":"Japanese Participants: AMG 133 Medium Dose","description":"Healthy Japanese participants received the medium dose of AMG 133 as a SC injection on Day 1 of the study."},{"id":"BG002","title":"Japanese Participants: AMG 133 High Dose","description":"Healthy Japanese participants received the high dose of AMG 133 as a SC injection on Day 1 of the study."},{"id":"BG003","title":"Caucasian Participants: AMG 133 Medium Dose","description":"Healthy Caucasian participants received the medium dose of AMG 133 as a SC injection on Day 1 of the study."},{"id":"BG004","title":"Caucasian Participants: AMG 133 High Dose","description":"Healthy Caucasian participants received the high dose of AMG 133 as a SC injection on Day 1 of the study."},{"id":"BG005","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"7"},{"groupId":"BG003","value":"7"},{"groupId":"BG004","value":"7"},{"groupId":"BG005","value":"34"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"57.3","spread":"4.80"},{"groupId":"BG001","value":"55.0","spread":"5.35"},{"groupId":"BG002","value":"52.9","spread":"13.90"},{"groupId":"BG003","value":"43.0","spread":"14.59"},{"groupId":"BG004","value":"49.0","spread":"11.93"},{"groupId":"BG005","value":"51.3","spread":"11.58"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"4"},{"groupId":"BG003","value":"1"},{"groupId":"BG004","value":"2"},{"groupId":"BG005","value":"13"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"3"},{"groupId":"BG003","value":"6"},{"groupId":"BG004","value":"5"},{"groupId":"BG005","value":"21"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"2"},{"groupId":"BG004","value":"4"},{"groupId":"BG005","value":"6"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"7"},{"groupId":"BG003","value":"5"},{"groupId":"BG004","value":"3"},{"groupId":"BG005","value":"28"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"White","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"7"},{"groupId":"BG004","value":"7"},{"groupId":"BG005","value":"14"}]},{"title":"Japanese","measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"7"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"20"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Maximum Observed Plasma Concentration (Cmax) of Intact AMG 133","description":"Blood samples were collected at specific times during the study for the measurement of plasma concentrations of intact and total AMG 133 by a laboratory.","populationDescription":"Pharmacokinetic (PK) Population: Included all participants who received at least 1 dose of AMG 133 and had evaluable PK data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"μg/mL","timeFrame":"Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose","groups":[{"id":"OG000","title":"Japanese Participants: AMG 133 Low Dose","description":"Healthy Japanese participants received the low dose of AMG 133 as a SC injection on Day 1 of the study."},{"id":"OG001","title":"Japanese Participants: AMG 133 Medium Dose","description":"Healthy Japanese participants received the medium dose of AMG 133 as a SC injection on Day 1 of the study."},{"id":"OG002","title":"Japanese Participants: AMG 133 High Dose","description":"Healthy Japanese participants received the high dose of AMG 133 as a SC injection on Day 1 of the study."},{"id":"OG003","title":"Caucasian Participants: AMG 133 Medium Dose","description":"Healthy Caucasian participants received the medium dose of AMG 133 as a SC injection on Day 1 of the study."},{"id":"OG004","title":"Caucasian Participants: AMG 133 High Dose","description":"Healthy Caucasian participants received the high dose of AMG 133 as a SC injection on Day 1 of the study."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"7"},{"groupId":"OG003","value":"7"},{"groupId":"OG004","value":"6"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"12.3","spread":"57.3"},{"groupId":"OG001","value":"22.7","spread":"24.1"},{"groupId":"OG002","value":"44.9","spread":"34.6"},{"groupId":"OG003","value":"22.5","spread":"33.9"},{"groupId":"OG004","value":"55.0","spread":"26.7"}]}]}]},{"type":"PRIMARY","title":"Cmax of Total AMG 133","description":"Blood samples were collected at specific times during the study for the measurement of plasma concentrations of intact and total AMG 133 by a laboratory.","populationDescription":"PK Population: Included all participants who received at least 1 dose of AMG 133 and had evaluable PK data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"μg/mL","timeFrame":"Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose","groups":[{"id":"OG000","title":"Japanese Participants: AMG 133 Low Dose","description":"Healthy Japanese participants received the low dose of AMG 133 as a SC injection on Day 1 of the study."},{"id":"OG001","title":"Japanese Participants: AMG 133 Medium Dose","description":"Healthy Japanese participants received the medium dose of AMG 133 as a SC injection on Day 1 of the study."},{"id":"OG002","title":"Japanese Participants: AMG 133 High Dose","description":"Healthy Japanese participants received the high dose of AMG 133 as a SC injection on Day 1 of the study."},{"id":"OG003","title":"Caucasian Participants: AMG 133 Medium Dose","description":"Healthy Caucasian participants received the medium dose of AMG 133 as a SC injection on Day 1 of the study."},{"id":"OG004","title":"Caucasian Participants: AMG 133 High Dose","description":"Healthy Caucasian participants received the high dose of AMG 133 as a SC injection on Day 1 of the study."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"7"},{"groupId":"OG003","value":"7"},{"groupId":"OG004","value":"6"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"13.2","spread":"56.3"},{"groupId":"OG001","value":"24.8","spread":"25.6"},{"groupId":"OG002","value":"48.4","spread":"32.0"},{"groupId":"OG003","value":"20.8","spread":"24.5"},{"groupId":"OG004","value":"58.7","spread":"24.8"}]}]}]},{"type":"PRIMARY","title":"Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of Intact AMG 133","description":"Blood samples were collected at specific times during the study for the measurement of plasma concentrations of intact and total AMG 133 by a laboratory.","populationDescription":"PK Population: Included all participants who received at least 1 dose of AMG 133 and had evaluable PK data. Only participants with available data are included.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"h*ug/mL","timeFrame":"Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose","groups":[{"id":"OG000","title":"Japanese Participants: AMG 133 Low Dose","description":"Healthy Japanese participants received the low dose of AMG 133 as a SC injection on Day 1 of the study."},{"id":"OG001","title":"Japanese Participants: AMG 133 Medium Dose","description":"Healthy Japanese participants received the medium dose of AMG 133 as a SC injection on Day 1 of the study."},{"id":"OG002","title":"Japanese Participants: AMG 133 High Dose","description":"Healthy Japanese participants received the high dose of AMG 133 as a SC injection on Day 1 of the study."},{"id":"OG003","title":"Caucasian Participants: AMG 133 Medium Dose","description":"Healthy Caucasian participants received the medium dose of AMG 133 as a SC injection on Day 1 of the study."},{"id":"OG004","title":"Caucasian Participants: AMG 133 High Dose","description":"Healthy Caucasian participants received the high dose of AMG 133 as a SC injection on Day 1 of the study."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"7"},{"groupId":"OG003","value":"5"},{"groupId":"OG004","value":"6"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"10600","spread":"45.2"},{"groupId":"OG001","value":"19400","spread":"36.0"},{"groupId":"OG002","value":"33500","spread":"20.5"},{"groupId":"OG003","value":"17200","spread":"42.4"},{"groupId":"OG004","value":"35700","spread":"31.1"}]}]}]},{"type":"PRIMARY","title":"AUClast of Total AMG 133","description":"Blood samples were collected at specific times during the study for the measurement of plasma concentrations of intact and total AMG 133 by a laboratory.","populationDescription":"PK Population: Included all participants who received at least 1 dose of AMG 133 and had evaluable PK data. Only participants with available data are included.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"h*ug/mL","timeFrame":"Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose","groups":[{"id":"OG000","title":"Japanese Participants: AMG 133 Low Dose","description":"Healthy Japanese participants received the low dose of AMG 133 as a SC injection on Day 1 of the study."},{"id":"OG001","title":"Japanese Participants: AMG 133 Medium Dose","description":"Healthy Japanese participants received the medium dose of AMG 133 as a SC injection on Day 1 of the study."},{"id":"OG002","title":"Japanese Participants: AMG 133 High Dose","description":"Healthy Japanese participants received the high dose of AMG 133 as a SC injection on Day 1 of the study."},{"id":"OG003","title":"Caucasian Participants: AMG 133 Medium Dose","description":"Healthy Caucasian participants received the medium dose of AMG 133 as a SC injection on Day 1 of the study."},{"id":"OG004","title":"Caucasian Participants: AMG 133 High Dose","description":"Healthy Caucasian participants received the high dose of AMG 133 as a SC injection on Day 1 of the study."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"7"},{"groupId":"OG003","value":"5"},{"groupId":"OG004","value":"6"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"14800","spread":"41.8"},{"groupId":"OG001","value":"28300","spread":"37.2"},{"groupId":"OG002","value":"47700","spread":"21.1"},{"groupId":"OG003","value":"20800","spread":"41.4"},{"groupId":"OG004","value":"49600","spread":"30.9"}]}]}]},{"type":"PRIMARY","title":"Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf) of Intact AMG 133","description":"Blood samples were collected at specific times during the study for the measurement of plasma concentrations of intact and total AMG 133 by a laboratory.","populationDescription":"PK Population: Included all participants who received at least 1 dose of AMG 133 and had evaluable PK data. Only participants with available data are included.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"h*ug/mL","timeFrame":"Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose","groups":[{"id":"OG000","title":"Japanese Participants: AMG 133 Low Dose","description":"Healthy Japanese participants received the low dose of AMG 133 as a SC injection on Day 1 of the study."},{"id":"OG001","title":"Japanese Participants: AMG 133 Medium Dose","description":"Healthy Japanese participants received the medium dose of AMG 133 as a SC injection on Day 1 of the study."},{"id":"OG002","title":"Japanese Participants: AMG 133 High Dose","description":"Healthy Japanese participants received the high dose of AMG 133 as a SC injection on Day 1 of the study."},{"id":"OG003","title":"Caucasian Participants: AMG 133 Medium Dose","description":"Healthy Caucasian participants received the medium dose of AMG 133 as a SC injection on Day 1 of the study."},{"id":"OG004","title":"Caucasian Participants: AMG 133 High Dose","description":"Healthy Caucasian participants received the high dose of AMG 133 as a SC injection on Day 1 of the study."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"7"},{"groupId":"OG003","value":"5"},{"groupId":"OG004","value":"6"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"10700","spread":"44.9"},{"groupId":"OG001","value":"19600","spread":"36.4"},{"groupId":"OG002","value":"33900","spread":"20.4"},{"groupId":"OG003","value":"17300","spread":"43.3"},{"groupId":"OG004","value":"36000","spread":"31.6"}]}]}]},{"type":"PRIMARY","title":"AUCinf of Total AMG 133","description":"Blood samples were collected at specific times during the study for the measurement of plasma concentrations of intact and total AMG 133 by a laboratory.","populationDescription":"PK Population: Included all participants who received at least 1 dose of AMG 133 and had evaluable PK data. 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