[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"healthy-male-adults\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:healthy-male-adults":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"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":45},"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",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":16,"sex":17,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":45},"100620707","phase-2-plan-a-occlusion-and-reversal-system-feasibility-study-100620707","NCT07361120","Plan A Occlusion and Reversal System Feasibility Study","Prospective, Multicenter, Single-arm, Open Label, Interventional Clinical Trial Investigating the Safety and Effectiveness of the Plan A Male Contraceptive System.","Inclusion Criteria:\n\n1. Male subject who is seeking and suitable to undergo a vasectomy as a long-term form of contraception\n2. Male subject who has voluntarily signed and dated the Institutional Review Board (IRB)\u002FEthics Committee (EC) approved informed consent form (ICF) for this study prior to initiation of any screening or study specific procedures\n3. 25 to 65 years of age at the time of consent\n4. Body Mass Index (BMI) \\\u003C31 kg\u002Fm2\n5. Good health for undergoing a vasectomy as confirmed by medical history, physical examination and clinical laboratory tests of blood and urine at the time of screening\n6. Normal semen analysis defined by the WHO Laboratory Manual for the Examination and Processing of Human Semen (6th Edition), based on the average of two semen samples ≥2 days and ≤7 days apart\n7. In the opinion of the Investigator, subject is suitable to undergo a vasectomy as a form of long-term contraception\n8. Agreement to use an effective method of contraception during the entire clinical trial until the planned vasectomy\n9. Lives in close proximity to the trial site to enable provision of fresh semen samples unless the subject agrees to provide semen samples at the trial site or laboratory\n\nExclusion Criteria:\n\n1. (On exam, has any of the following); one or both vasa not present, abnormal scrotum, large varicocele, hydrocele, filariasis or elephantiasis of scrotum, or intrascrotal mass that would make the subject not suitable for the study.\n2. Prior testicular surgery, testicular injury or prior vasectomy with vasovasostomy (vasectomy reversal)\n3. Recurrent pain with ejaculations\n4. Has known allergic reaction to sulfur-containing products or has had a prior severe allergic response to injectable or implantable devices\n5. Has local genital infections such as balanitis, scrotal skin infection, epididymitis, or orchitis, or tender (inflamed) tip of the penis, but may be enrolled after resolution of an acute infection\n6. History of prostatitis or benign prostatic hypertrophy requiring treatment\n7. Has undergone prior chemotherapy\n8. Has known current coagulopathy or other bleeding disorders\n9. Currently taking or planning to take any type of systemic medication which could affect sperm count or ejaculation (e.g., anabolic steroids, chemotherapy, alpha blocker)\n10. Subjects with cystic fibrosis\n11. Subjects with a history of inguinal hernia repair\n12. Vulnerable subjects (e.g., subjects with cognitive challenges, incarcerated, etc.)\n13. Currently participating in another study involving an investigational device or drug (or has participated in a study within the last 30 days prior to screening).\n14. Any site staff member with delegated study responsibilities or a family member of a site staff member with delegated study responsibilities\n15. In the opinion of the Investigator, there are issues or concerns that may compromise the safety of the subject or confound the reliability of compliance and information acquired in this study\n16. Has any condition that, in the opinion of the Investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results.","25 Years","65 Years",{"count":56,"type":22},40,[58],"PHASE2","Prospective, multicenter, single-arm, open label, interventional clinical trial investigating the safety and effectiveness of the Plan A Male Contraceptive System to occlude the vas deferens to block the passage of sperm and then be reversed to subsequently allow the passage of sperm through the vas deferens.",[61,62,28],"Fertility","Fertility, Male",[64],"Vasectomy, Fertility, Reproductive Health, Male Contraception, Vas Occlusion, No Scalpel Vasectomy,","2026-01-14",{"date":67,"type":37},"2026-01-22",{"date":69,"type":22},"2026-01",{"date":71,"type":22},"2026-09",{"name":73,"class":44},"Next Life Sciences"]