[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600137":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":61,"collaborators":25,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":25,"eligibilityCriteria":69,"healthyVolunteers":70,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":25,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":39,"whyStopped":25,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":102},{"fullName":5,"class":6},"Shionogi Inc.","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Part 1 (Single Ascending Dose)","EXPERIMENTAL","Participants will receive a single dose of S-892216-LAI or placebo on Day 1.",[13,14],"Drug: S-892216-LAI","Drug: Placebo",{"label":16,"type":10,"description":17,"interventionNames":18},"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.",[13,14],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","S-892216-LAI","S-892216-LAI injection will be administered per schedule specified in the arm description.",[9,16],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Placebo","Physiological saline will be administered per schedule specified in the arm description.",[9,16],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Shionogi Clinical Trials Administrator Clinical Support Help Line","CONTACT","800-849-9707","Shionogiclintrials-admin@shionogi.co.jp",[37,51],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":25},"ICON Clinical Research: Lenexa","RECRUITING","Lenexa","Kansas","66219","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-94.73357,38.95362,{"lat":49,"lon":48},{"facility":52,"status":39,"city":53,"state":54,"zip":55,"country":43,"countryCode":44,"cosmosGeoPoint":56,"geoPoint":60,"contacts":25},"ICON Clinical Research: Salt Lake City","Salt Lake City","Utah","84124",{"type":46,"coordinates":57},[58,59],-111.89105,40.76078,{"lat":59,"lon":58},{"type":62,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100600137","phase-1-study-of-s-892216-long-acting-injectable-lai-in-healthy-adult-participants-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":75,"type":76},98,"ESTIMATED","INTERVENTIONAL",[79],"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.",[82],"Healthy Participants",[84,85,86,22,87,88,89,90,91],"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":94,"type":95},"2025-08-27","ACTUAL",{"date":97,"type":95},"2025-07-29",{"date":99,"type":76},"2027-05-26",{"name":101,"class":6},"Shionogi",2]