[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"AnnJi Pharmaceutical Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":45},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":5},"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":21,"type":22},26,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29],"Healthy Male Adults","Food Effect in Healthy Volunteers",[28,31,32],"Healthy Volunteers","Food Effect","RECRUITING","2026-04-19",{"date":36,"type":37},"2026-04-24","ACTUAL",{"date":39,"type":37},"2026-04-09",{"date":41,"type":22},"2026-04-27",{"name":43,"class":44},"AnnJi Pharmaceutical Co., Ltd.","INDUSTRY",""]