[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650205":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":33,"centralContacts":37,"locations":43,"responsibleParty":58,"collaborators":32,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":32,"eligibilityCriteria":66,"healthyVolunteers":67,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":32,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":46,"whyStopped":32,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Amgen","INDUSTRY",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1","EXPERIMENTAL","Chinese participants will receive AMG 691 at the Level A dose administered subcutaneously (SC)",[13],"Drug: AMG 691",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort 2","Japanese participants will receive AMG 691 at the Level A dose administered SC",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Cohort 3","Chinese participants will receive AMG 691 at the Level B dose administered SC",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Cohort 4","Japanese participants will receive AMG 691 at the Level B dose administered SC",[13],[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","AMG 691","AMG 691 will be administered subcutaneously",[9,15,19,23],null,[34],{"name":35,"affiliation":5,"role":36},"MD","STUDY_DIRECTOR",[38],{"name":39,"role":40,"phone":41,"phoneExt":32,"email":42},"Amgen Call Center","CONTACT","866-572-6436","medinfo@amgen.com",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":32},"PPD - Las Vegas Research Unit","RECRUITING","Las Vegas","Nevada","89113","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-115.13722,36.17497,{"lat":56,"lon":55},{"type":59,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100650205","phase-1-a-phase-1-trial-of-amg-691-in-healthy-chinese-and-japanese-volunteers-100650205",false,"NCT07745907","A Phase 1 Trial of AMG 691 in Healthy Chinese and Japanese Volunteers","A Phase 1, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of AMG 691 Administered in Healthy Chinese and Japanese Participants","Inclusion Criteria:\n\n* Healthy male or female participants, 18 to 60 years of age.\n* First-generation Chinese ancestry (born in China, Hong Kong, Taiwan, or Macau with 2 Chinese parents and 4 Chinese grandparents) or first-generation Japanese ancestry (born in Japan with 2 Japanese parents and 4 Japanese grandparents).\n* Body mass index (BMI) 18.0 to 30.0 kg\u002Fm\\^2 (inclusive) and body weight ≥40 kg.\n* In good general health based on medical history, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory evaluations.\n* Female participants must not be pregnant or breastfeeding.\n* Participants of reproductive potential must agree to follow protocol-specified contraception requirements.\n* Willing to maintain usual diet and physical activity regimen throughout study participation.\n\nExclusion Criteria:\n\n* Clinically significant medical condition, disease, or abnormal finding that could interfere with study participation or interpretation of results.\n* Clinically significant ECG abnormalities\n* Clinically significant abnormal blood pressure or pulse rate at screening\u002Fcheck-in.\n* History of malignancy (except adequately treated in situ cervical cancer or non-melanoma skin cancer \\>5 years before dosing).\n* Deep vein thrombosis or pulmonary embolism within 3 months prior to check-in.\n* History of hypersensitivity\u002Fanaphylaxis to biologic therapies, mammalian-derived products, or AMG 691 excipients.\n* Active, chronic, recurrent, or unresolved infection; history of severe infection requiring intravenous (IV) antibiotics within the past 3 years.\n* Positive or indeterminate QuantiFERON-TB Gold test.\n* Untreated or unresolved helminth parasitic infection.\n* History of immunodeficiency.\n* Receipt of live or live-attenuated vaccines within 12 weeks before check-in or planned during the study.\n* Estimated glomerular filtration rate (eGFR) \\\u003C70 mL\u002Fmin\u002F1.73 m\\^2.\n* Alanine Aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, or direct bilirubin \\>1.5 × Upper Limit Normal (ULN).\n* Positive screening tests for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection.\n* Use of prohibited prescription, over-the-counter, herbal, vitamin, or dietary supplement products within 30 days (or 5 half-lives) before enrollment, unless approved by the investigator.\n* History of illicit drug use within 1 year, positive drug screen, or unwillingness to abstain from illicit drugs\u002Fcannabinoids during the study.\n* Use of tobacco or nicotine-containing products within 6 months prior to check-in.\n* History of alcohol abuse or excessive alcohol consumption.\n* History of non-suicidal self-injury within 5 years or unstable major depressive disorder\u002Fother severe psychiatric disorder within 2 years.\n* Participation in another investigational drug study within 90 days (or 5 half-lives) prior to check-in.\n* Previous exposure to AMG 691.\n* Recent donation of blood, plasma, or platelets.\n* Any participant considered unsuitable by the investigator or unwilling to comply with study restrictions.",true,"ALL","18 Years","60 Years",{"count":72,"type":73},28,"ESTIMATED","INTERVENTIONAL",[76],"PHASE1","The trial is designed to evaluate the pharmacokinetics, safety, tolerability, and immunogenicity of AMG 691 in healthy Chinese and Japanese participants",[79],"Healthy Participants",[29,81,82,83],"Respiratory Tract Diseases","Asthma","Lung Diseases","2026-07-30",{"date":86,"type":87},"2026-08-04","ACTUAL",{"date":89,"type":73},"2026-08-07",{"date":91,"type":73},"2027-03-31",{"name":5,"class":6},1]