[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651129":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":41,"responsibleParty":59,"collaborators":17,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":17,"eligibilityCriteria":67,"healthyVolunteers":68,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":17,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":43,"whyStopped":17,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Chengdu Zenitar Biomedical Technology Co., Ltd","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ZL65 Tables","EXPERIMENTAL","ZL65",[13],"Drug: This group of participants take ZL-65 tablet",{"label":15,"type":16,"description":17,"interventionNames":18},"ZL65-Placebo Tables","PLACEBO_COMPARATOR",null,[19],"Drug: This group of participants take ZL-65 placebo tablet",[21,26],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":17},"DRUG","This group of participants take ZL-65 tablet","ZL65 Tablet 5mg ZL65 Tablet 10mg ZL65 Tablet 25mg ZL65 Tablet 50mg ZL65 Tablet 75mg ZL65 Tablet 100mg ZL65 Tablet 125mg",[9],{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":17},"This group of participants take ZL-65 placebo tablet","ZL65 Placebo Tablet 5mg ZL65 Placebo Tablet 10mg ZL65 Placebo Tablet 25mg ZL65 PlaceboTablet 50mg ZL65 Placebo Tablet 75mg ZL65 Placebo Tablet 100mg ZL65 Placebo Tablet 125mg",[15],[31],{"name":32,"affiliation":33,"role":34},"Yong Xiaolan, Doctor","Chengdu Xinhua Hospital","PRINCIPAL_INVESTIGATOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":17,"email":40},"Wang Fangmei","CONTACT","+8613808086495","fangmei.wang@zenitar.cn",[42],{"facility":33,"status":43,"city":44,"state":45,"zip":17,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"RECRUITING","Chengdu","Sichuan","China","CN",{"type":49,"coordinates":50},"Point",[51,52],104.06667,30.66667,{"lat":52,"lon":51},[55],{"name":56,"role":38,"phone":57,"phoneExt":17,"email":58},"Xie Daiyan","+86 158 8132 2123","cdxhyyll@126.com",{"type":60,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR","100651129","phase-1-phase-i-clinical-study-of-zl-65-tablet-in-healthy-adult-participants-in-china-100651129",false,"NCT07757152","Phase I Clinical Study of ZL-65 Tablet in Healthy Adult Participants in China","Phase I Clinical Study of ZL-65 Tablet in Healthy Adult Participants in China: Randomized, Double-blind, Placebo-controlled, Single\u002FMultiple Oral Dose Escalation for Safety Tolerability, Pharmacokinetics, Preliminary Pharmacodynamics, and Food Effect","Inclusion Criteria:\n\n1. Healthy adult participants for the Chinese trial, gender-neutral, aged 18 to 45;\n2. Male trial participants weighing \\>= 50.0 kg, female trial participants weighing \\>=45.0 kg, with a body mass index (BMI) between 19.0 and 28.0 kg\u002Fm\\^2;\n3. Those who can understand the informed consent form, voluntarily participate in the experiment, and sign the informed consent form.\n\nExclusion Criteria:\n\n1. Individuals with allergies or a history of clinically significant food, drug allergies, or other allergic diseases as determined by researchers; Or those who are known to be allergic to NLRP3 inhibitors or to the excipients contained in the test drug;\n2. .Individuals with any serious illness or medical history of cardiovascular system, digestive system, urinary system, respiratory system, nervous system, immune system, endocrine system, malignant tumors, mental illness, etc;\n3. Pregnant or lactating women or women of childbearing age who have had unprotected sexual intercourse with their partners within 14 days prior to screening; Or those with positive results in blood pregnancy test;\n4. Within 48 hours prior to administration, consuming any food or beverage containing caffeine, or fruits or vegetables containing grapefruit juice, soybeans, flavonoids that may affect metabolic enzymes, or consuming foods or beverages containing alcohol。",true,"ALL","18 Years","45 Years",{"count":73,"type":74},108,"ESTIMATED","INTERVENTIONAL",[77],"PHASE1","To evaluate the tolerability and safety of a single oral dose of ZL-65 tablets in healthy adult trial participants through dose escalation; and to preliminarily assess the pharmacokinetic and pharmacodynamic characteristics of a single oral dose of ZL-65 tablets.Exploring the impact of food intake on the PK of orally administered ZL-65 tablets in healthy adult trial participants.",[80],"Healthy Participants Study",[11],"2026-08-05",{"date":84,"type":85},"2026-08-11","ACTUAL",{"date":87,"type":85},"2026-07-23",{"date":89,"type":74},"2027-12-30",{"name":5,"class":6},1]