[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Tune Therapeutics, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":48},{"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":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100567661","phase-1-phase-1b-open-label-study-of-tune-401-to-assess-safety-pk-and-pd-in-adults-with-chronic-hepatitis-b-100567661",false,"NCT06671093","Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B","Phase 1b Multicenter, Open-Label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Tune-401 in Participants With Chronic Hepatitis B Infection","Inclusion Criteria:\n\n* M\u002FF, BMI ≥ 18.5 kg\u002Fm² at screening, age 18-75, inclusive\n* Diagnosed with Chronic Hepatitis B\n* On nucleos(t)ide analogue\n* HBeAg-negative or positive\n\nExclusion Criteria:\n\n* ALT\u002F AST ≥ 1.5 × upper limit of normal (ULN) and total bilirubin ≥ 1. 5 × ULN\n* Participants with any evidence or history of liver disease of non-HBV etiology\n* Other protocol defined Inclusion\u002FExclusion criteria may apply","ALL","18 Years","75 Years",{"count":20,"type":21},36,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This study will be conducted to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of Tune-401 in adult participants with Chronic Hepatitis B.",[27,28,29,30],"Chronic Hep B","Chronic Hepatitis b","Chronic Hepatitis","HBV",[32,33,34],"Tune-401","Tune-401-001","CHB","RECRUITING","2026-01-02",{"date":38,"type":39},"2026-01-06","ACTUAL",{"date":41,"type":39},"2024-11-29",{"date":43,"type":21},"2028-10-30",{"name":45,"class":46},"Tune Therapeutics, Inc.","INDUSTRY",3,""]