[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606747":3},{"organization":4,"armGroups":7,"interventions":36,"overallOfficials":42,"centralContacts":42,"locations":47,"responsibleParty":72,"collaborators":42,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":42,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":42,"studyType":87,"phases":88,"briefSummary":91,"conditions":92,"keywords":42,"overallStatus":50,"whyStopped":42,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Shanghai Longwood Biopharmaceuticals Co., Ltd.","INDUSTRY",[8,15,19,23,27,31],{"label":9,"type":10,"description":11,"interventionNames":12},"Part1: LW231 Dose 1","EXPERIMENTAL","LW231 Dose Escalation Cohort 1, administered orally, QD",[13,14],"Drug: LW231","Drug: LW231 placebo",{"label":16,"type":10,"description":17,"interventionNames":18},"Part1: LW231 Dose 2","LW231 Dose Escalation Cohort 2, administered orally, BID",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"Part1: LW231 Dose 3","LW231 Dose Escalation Cohort 2, administered orally, QD",[13,14],{"label":24,"type":10,"description":25,"interventionNames":26},"Part2: LW231 treatment group 1","LW231 administered orally, BID + NUCs",[13],{"label":28,"type":10,"description":29,"interventionNames":30},"Part2: LW231 treatment group 2","LW231 administered orally, QD +NUCs",[13],{"label":32,"type":33,"description":34,"interventionNames":35},"Part2: LW231 placebo group","PLACEBO_COMPARATOR","LW231 placebo + NUCs",[14],[37,43],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"DRUG","LW231","LW231 tablets",[9,16,20,24,28],null,{"type":38,"name":44,"description":45,"armGroupLabels":46,"otherNames":42},"LW231 placebo","LW231 placebo tablets",[9,16,20,32],[48,67],{"facility":49,"status":50,"city":51,"state":52,"zip":42,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"The First Affiliated Hospital, Zhejiang University School of Medicine","RECRUITING","Hangzhou","Zhejiang","China","CN",{"type":56,"coordinates":57},"Point",[58,59],120.16142,30.29365,{"lat":59,"lon":58},[62],{"name":63,"role":64,"phone":65,"phoneExt":42,"email":66},"Yunqing Qiu","CONTACT","+86 13588189339","qiuyq@zju.edu.cn",{"facility":49,"status":68,"city":51,"state":42,"zip":42,"country":53,"countryCode":54,"cosmosGeoPoint":69,"geoPoint":71,"contacts":42},"NOT_YET_RECRUITING",{"type":56,"coordinates":70},[58,59],{"lat":59,"lon":58},{"type":73,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR","100606747","phase-1-study-of-lw231-in-participants-with-chronic-hepatitis-b-100606747",false,"NCT07179575","Study of LW231 in Participants With Chronic Hepatitis B","Phase Ib\u002FII Study of LW231 in Patients With Chronic Hepatitis B: Evaluation of Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy With Multiple-Dose, Dose-Escalation, and Combination With Nucleos(t)Ide Analogs (NUC)","Inclusion Criteria:\n\n* Part 1: treatment-naïve and currently not treated subjects: LLOQ\\\u003CHBV DNA≤20000 IU\u002Fml; 100 IU\u002FmL\\\u003CHBsAg\\\u003C10000 IU\u002Fml\n* Part 2: HBV DNA\\\u003CLLOQ or \\\u003C 20 IU\u002FmL at screening; 100 IU\u002FmL\\\u003CHBsAg\\\u003C3000 IU\u002FmL\n\nExclusion Criteria:\n\n* Co-infection with hepatitis A, C, D, E or HIV or any evidence of clinically significant liver disease of non-HBV etiology.\n* History or current evidence of cirrhosis.\n* ALT or AST\\>3×ULN; TBil\\>1.3×ULN or DBil\\>1.3×ULN; INR\\>1.3×ULN","ALL","18 Years","60 Years",{"count":85,"type":86},270,"ESTIMATED","INTERVENTIONAL",[89,90],"PHASE1","PHASE2","This is a Phase Ib\u002FII, multicenter, randomized, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of LW231 in participants with chronic hepatitis B virus (HBV) infection. The trial will include multiple-dose regimens of LW231 and assess LW231 in combination with NUCs.",[93],"Chronic HBV Infection","2025-09-28",{"date":96,"type":97},"2025-10-02","ACTUAL",{"date":99,"type":86},"2025-10",{"date":101,"type":86},"2027-11",{"name":5,"class":6},2]