[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639398":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":27,"centralContacts":31,"locations":37,"responsibleParty":52,"collaborators":26,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":26,"eligibilityCriteria":60,"healthyVolunteers":61,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":26,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":40,"whyStopped":26,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"AbbVie","INDUSTRY",[8,14,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1-Bretisilocin-Japanese","EXPERIMENTAL","Participants will receive bretisilocin intramuscular (IM) injection on day 1.",[13],"Drug: Bretisilocin",{"label":15,"type":10,"description":11,"interventionNames":16},"Group 1-Bretisilocin-Han Chinese",[13],{"label":18,"type":10,"description":11,"interventionNames":19},"Group 1-Bretisilocin-Non-Asian",[13],[21],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Bretisilocin","Intramuscular Injection",[15,9,18],null,[28],{"name":29,"affiliation":5,"role":30},"ABBVIE INC.","STUDY_DIRECTOR",[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"ABBVIE CALL CENTER","CONTACT","844-663-3742","abbvieclinicaltrials@abbvie.com",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":26},"CenExel Collaborative Neuroscience Research \u002FID# 281612","RECRUITING","Los Alamitos","California","90720","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-118.07256,33.80307,{"lat":50,"lon":49},{"type":53,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100639398","phase-1-a-study-to-assess-the-adverse-events-and-how-bretisilocin-intramuscular-injection-moves-through-the-body-of-healthy-adult-participants-100639398",false,"NCT07604558","A Study to Assess the Adverse Events and How Bretisilocin Intramuscular Injection Moves Through the Body of Healthy Adult Participants","An Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single Dose of Bretisilocin in Healthy Adult Japanese, Han Chinese, and Non-Asian Volunteers","Inclusion Criteria:\n\n* Group 1: Healthy adult Japanese male or female;\n\n  • Japanese participants must be first-generation Japanese of full Japanese parentage residing outside of Japan for less than 5 years.\n* Group 2: Healthy adult Han Chinese male or female\n\n  • Han Chinese participants must be first-generation Han Chinese of full Chinese parentage residing outside of China for less than 5 years.\n* Group 3: Healthy adult male or female volunteers of African, European, or Latin American descent.\n* A condition of general good health, based upon the results of a medical history, physical and neurological examination, vital signs, laboratory profile and 12-lead ECG.\n\nExclusion Criteria:\n\n* Current diagnosis or history of any clinically significant mental health disorder, cardiovascular disorder, metabolic disorder, or other disorder requiring pharmacologic or other medical treatment. (Previous psychological support without a diagnosed history of a mental health disorder would not be considered exclusionary.)\n* Clinically significant personal or familial history (first degree relative) of epilepsy, seizures, convulsions, or other seizure disorder (excluding febrile seizures as a child), previous head trauma or other risk factor for seizure (e.g., electrolyte disturbances, or structural neurological disorders).\n* Any use of psychoactive substances (including ketamine, esketamine, MDMA, cannabinoids, or nitrous oxide) during the 6 weeks prior to confinement.",true,"ALL","18 Years","65 Years",{"count":66,"type":67},26,"ESTIMATED","INTERVENTIONAL",[70],"PHASE1","This study will assess the adverse events, tolerability, and how bretisilocin intramuscular (IM) Injection moves through the body of healthy adult Japanese, Han Chinese, and Non-Asian volunteers participants.",[73],"Healthy Volunteer",[73,23,75],"ABBV-2505","2026-06-22",{"date":78,"type":79},"2026-06-24","ACTUAL",{"date":81,"type":79},"2026-05-26",{"date":83,"type":67},"2026-09",{"name":5,"class":6},1]