[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600137":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":11,"studyPopulation":11,"armGroups":42,"interventions":54,"overallOfficials":11,"centralContacts":64,"locations":70,"responsibleParty":95,"collaborators":11,"id":97,"slug":11,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":11,"eligibilityCriteria":102,"healthyVolunteers":103,"sex":104,"minAge":105,"maxAge":106,"enrollmentInfo":107,"targetDuration":11,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":73,"whyStopped":11,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":135},{"fullName":5,"class":6},"Shionogi Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":11},[9,13],{"measure":10,"description":11,"timeFrame":12},"Part: Number of Participants With Treatment-emergent Adverse Events (TEAEs)",null,"Day 1 through Day 364",{"measure":14,"description":11,"timeFrame":15},"Part 2: Number of Participants With TEAEs","Day 1 through Day 448",[17,20,23,25,27,29],{"measure":18,"description":11,"timeFrame":19},"Part 1: Maximum Plasma Concentration (Cmax) of S-892216 and its Metabolites","Day 1 (pre-administration, up to 12 hours post-administration) through Day 364",{"measure":21,"description":11,"timeFrame":22},"Part 2: Cmax of S-892216 and its Metabolites","Day 1 (pre-administration, up to 12 hours post-administration) through Day 70 in Treatment Period 1 and Day 85 (pre-administration, up to 12 hours post-administration) through Day 448 in Treatment Period 2",{"measure":24,"description":11,"timeFrame":19},"Part 1: Time to Reach Cmax (Tmax) of S-892216 and its Metabolites",{"measure":26,"description":11,"timeFrame":22},"Part 2: Tmax of S-892216 and its Metabolites",{"measure":28,"description":11,"timeFrame":19},"Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration After Dosing (AUC0-last) of S-892216 and its Metabolites",{"measure":30,"description":11,"timeFrame":22},"Part 2: AUC0-last of S-892216 and its Metabolites",{"allocation":32,"interventionModel":33,"interventionModelDescription":11,"primaryPurpose":34,"observationalModel":11,"timePerspective":11,"maskingInfo":35},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":36,"maskingDescription":11,"whoMasked":37},"QUADRUPLE",[38,39,40,41],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[43,50],{"label":44,"type":45,"description":46,"interventionNames":47},"Part 1 (Single Ascending Dose)","EXPERIMENTAL","Participants will receive a single dose of S-892216-LAI or placebo on Day 1.",[48,49],"Drug: S-892216-LAI","Drug: Placebo",{"label":51,"type":45,"description":52,"interventionNames":53},"Part 2 (Multiple Ascending Dose)","Participants will receive multiple doses of S-892216-LAI or placebo on Day 1 and Day 85 in treatment periods 1 and 2, respectively.",[48,49],[55,60],{"type":56,"name":57,"description":58,"armGroupLabels":59,"otherNames":11},"DRUG","S-892216-LAI","S-892216-LAI injection will be administered per schedule specified in the arm description.",[44,51],{"type":56,"name":61,"description":62,"armGroupLabels":63,"otherNames":11},"Placebo","Physiological saline will be administered per schedule specified in the arm description.",[44,51],[65],{"name":66,"role":67,"phone":68,"phoneExt":11,"email":69},"Shionogi Clinical Trials Administrator Clinical Support Help Line","CONTACT","800-849-9707","Shionogiclintrials-admin@shionogi.co.jp",[71,85],{"facility":72,"status":73,"city":74,"state":75,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":11},"ICON Clinical Research: Lenexa","RECRUITING","Lenexa","Kansas","66219","United States","US",{"type":80,"coordinates":81},"Point",[82,83],-94.73357,38.95362,{"lat":83,"lon":82},{"facility":86,"status":73,"city":87,"state":88,"zip":89,"country":77,"countryCode":78,"cosmosGeoPoint":90,"geoPoint":94,"contacts":11},"ICON Clinical Research: Salt Lake City","Salt Lake City","Utah","84124",{"type":80,"coordinates":91},[92,93],-111.89105,40.76078,{"lat":93,"lon":92},{"type":96,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100600137",false,"NCT07093580","Study of S-892216 Long-acting Injectable (LAI) in Healthy Adult Participants","Phase 1 Study of a Long-acting Injectable S-892216 in Healthy Adult Participants","Key Inclusion Criteria:\n\n* Body mass index (BMI) ≥18.5 and ≤32.0 kilograms (kg)\u002Fsquare meter (m\\^2)\n\nKey Exclusion Criteria:\n\n* Presence or history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, neurological, or ophthalmological (for example, increased intra-ocular pressure) disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data per the investigator's assessment.\n* History of cancer except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.\n* Require medication or other treatment (for example, dietary restrictions or physical therapy).\n* Participated in any other clinical study involving an investigational study intervention or any other type of medical research within 30 days, or 5 times the half-life of the investigational drug, before signing of the informed consent form (ICF) for this study or who are currently participating in such a study.\n* Positive test results of the following at screening or within 6 months prior to administration of study intervention: hepatitis B surface antigen (HBsAg); hepatitis C virus antibody (HCV); and human immunodeficiency virus (HIV) antigen\u002Fantibody.\n* Positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) reverse transcription polymerase chain reaction (RT-PCR) test result, positive transcription-mediated amplification test result, positive antigen test result, or any other test approved according to local regulations at check in for each period on admission.\n* Known allergy\u002Fsensitivity or any hypersensitivity to components of S-892216-LAI or placebo for S-892216-LAI.\n* Used cannabis (medical or recreational), tobacco, or nicotine-containing products (including e-cigarettes, pipe tobacco, cigar, chewing tobacco, nicotine patch, and nicotine gum) within 6 months prior to admission.\n\nNote: Other protocol-defined inclusion\u002Fexclusion criteria may apply.",true,"MALE","18 Years","55 Years",{"count":108,"type":109},98,"ESTIMATED","INTERVENTIONAL",[112],"PHASE1","The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics (PK) of single- and multiple-dose administration of S-892216-LAI in healthy adults.",[115],"Healthy Participants",[117,118,119,57,120,121,122,123,124],"First-in-human (FIH)","Long-acting injectable (LAI) formulation","S-892216","Severe acute respiratory syndrome coronavirus 2","SARS-CoV-2 infection","Novel Coronavirus","Coronavirus Disease 2019","COVID-19","2025-08-20",{"date":127,"type":128},"2025-08-27","ACTUAL",{"date":130,"type":128},"2025-07-29",{"date":132,"type":109},"2027-05-26",{"name":134,"class":6},"Shionogi",2]