[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Neuracle Science Co., LTD.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":51},{"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":27,"conditions":28,"keywords":31,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100535291","phase-1-a-phase-1b2a-study-evaluating-the-safety-pkpd-and-efficacy-of-ns101-in-healthy-volunteers-and-ssnhl-patients-100535291",false,"NCT06249919","A Phase 1b\u002F2a, Study Evaluating the Safety, PK\u002FPD and Efficacy of NS101 in Healthy Volunteers and SSNHL Patients","A Phase 1b\u002F2a, Double-blinded, Placebo-controlled, Multiple Doses, 2 Step-up Study Evaluating the Safety, Tolerability, PK\u002FPD and Efficacy of Systemic NS101 in Healthy Volunteers and SSNHL Patients","Part A: healthy volunteers\n\nPart B:\n\nInclusion Criteria:\n\n* unilateral ideopathic SSNHL greater than 45dB at the average of 4 frequencies in PTA (contralateral hearing is less than 30dB)\n* Subject who has completed investigator-recognized standard treatment within 30 days of symptom onset and is able to undergo randomization visit within 35 days.\n* Subjects who, in the opinion of the investigator, have received sufficient systemic steroid therapy for approximately 2 weeks recovery\n* A combination regimen consisting of approximately 2 weeks of systemic steroid therapy and intratympanic steroid administration\n\nExclusion Criteria:\n\n* other otologic or systemic diseases\n* retrocochlear lesion",true,"ALL","19 Years","70 Years",{"count":21,"type":22},138,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","The goal of this 2 step-up, exploratory study is to test safey, tolerability and PK\u002FPD profiles in healthy volunteers and safety, tolerability and efficacy in sudden sensorineural hearing loss patients as an early salvage therapy.\n\nThe main questions it aims to answer are:\n\n1. whether is it safe and tolerable when healthy volunteers and sudden sensorineural hearing loss patients take multiple doses of NS101 against FAM19A5\n2. whether is it effective in reversing hearing capability in sudden sensorineural hearing loss patients who fails to show sufficient recovery despite of oral standard steroid therapy.\n\nPatients and heathly volunteers will be given NS101 15mg\u002Fkg or 30mg\u002Fkg systemically less than 3 months per protocol.\n\nThis is placebo controlled, double blinded study, which means there will be a group who receives placebo (i.e. fake drug) for study purpose.",[29,30],"Seneorineural Deafness","Sudden Sensorineural Hearing Loss",[32,33,34,35,36,37],"Sensorineural disease","sudden sensorineural hearing loss","sensorineural hearing loss","sudden deafness","cochlear synaptopathy","hidden auditory synaptopathy","RECRUITING","2025-08-07",{"date":41,"type":42},"2025-08-13","ACTUAL",{"date":44,"type":42},"2024-01-19",{"date":46,"type":22},"2027-01-31",{"name":48,"class":49},"Neuracle Science Co., LTD.","INDUSTRY",16,""]