[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635225":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":25,"locations":32,"responsibleParty":52,"collaborators":24,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":24,"eligibilityCriteria":60,"healthyVolunteers":61,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":24,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":75,"overallStatus":35,"whyStopped":24,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"AnnJi Pharmaceutical Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A (Japanese)","EXPERIMENTAL","Japanese Participants",[13],"Drug: AJ201",{"label":15,"type":10,"description":16,"interventionNames":17},"Arm B (White)","White Participants",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","AJ201","All participants are planned to be administered a single dose of AJ201 for each period (fed and fasted).",[9,15],null,[26],{"name":27,"role":28,"phone":29,"phoneExt":30,"email":31},"Andy Chen, PhD","CONTACT","+886223655677","801","andy.chen@ajpharm.com",[33],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"AnnJi Investigational Site","RECRUITING","Los Alamitos","California","90720","United States","US",{"type":42,"coordinates":43},"Point",[44,45],-118.07256,33.80307,{"lat":45,"lon":44},[48],{"name":49,"role":28,"phone":50,"phoneExt":24,"email":51},"CNS Outreach","844-424-9494","cns.outreach@cenexel.com",{"type":53,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100635225","phase-1-a-study-to-evaluate-the-effect-of-food-on-the-bioavailability-of-aj201-and-safety-tolerability-and-pharmacokinetics-of-aj201-in-japanese-and-white-healthy-male-participants-100635225",false,"NCT07549919","A Study to Evaluate the Effect of Food on the Bioavailability of AJ201, and Safety, Tolerability, and Pharmacokinetics of AJ201 in Japanese and White Healthy Male Participants","A Phase 1, Randomized, Single-dose, Open-label, Two-way, Crossover Study to Evaluate the Effect of Food on AJ201, and to Evaluate the Safety, Tolerability, and Pharmacokinetics of AJ201 in Japanese and White Healthy Male Participants","Key Inclusion Criteria:\n\n* Male, non-smokers (no use of tobacco or nicotine products within 3 months prior to Screening), ≥ 18 and ≤ 55 years of age, with body mass index (BMI) ≥ 18.5 and ≤ 30.0 kg\u002Fm2 and body weight ≥ 50.0 kg.\n* Normal renal function at Screening.\n* Healthy as defined by:\n\n  * The absence of clinically significant illness and surgery within 4 weeks prior to study drug administration.\n  * The absence of a clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, depression, attempted suicide, gastrointestinal, renal, hepatic, and metabolic disease.\n* Participants must be either Japanese or White.\n* Able to understand the study procedures and provide signed informed consent to participate in the study.\n\nKey Exclusion Criteria:\n\n* Any clinically significant abnormal finding at physical examination.\n* Clinically significant abnormal laboratory test results or positive serology test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen and antibody, at Screening.\n* Positive urine drug screen, urine cotinine test, or alcohol breath test.\n* History of significant allergic reactions to any drug.\n* Clinically significant ECG abnormalities or vital signs abnormalities at Screening.\n* History of drug abuse of any soft drugs or hard drugs.\n* History of alcohol abuse.\n* History of smoking or uses other nicotine-containing products.\n* Undergone major surgery ≤ 3 months before first study drug administration.\n* History of clinically significant opportunistic infection or serious local infection or significant medical\u002Fsurgical procedure or trauma or any current infection.\n* Use of medications for the timeframes specified in the protocol.\n* Presence of orthodontic braces or orthodontic retention wires, or any physical findings in the mouth or tongue that would interfere with the dosing procedure.",true,"MALE","18 Years","55 Years",{"count":66,"type":67},26,"ESTIMATED","INTERVENTIONAL",[70],"PHASE1","This is a Phase 1, randomized, single-dose, open-label, two-way crossover study to evaluate the effect of food on AJ201, and to evaluate the safety, tolerability, and pharmacokinetics of AJ201 in Japanese and White healthy male participants.",[73,74],"Healthy Male Adults","Food Effect in Healthy Volunteers",[73,76,77],"Healthy Volunteers","Food Effect","2026-04-19",{"date":80,"type":81},"2026-04-24","ACTUAL",{"date":83,"type":81},"2026-04-09",{"date":85,"type":67},"2026-04-27",{"name":5,"class":6},1]