[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642992":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":24,"locations":25,"responsibleParty":63,"collaborators":24,"id":65,"slug":24,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":24,"studyType":78,"phases":79,"briefSummary":82,"conditions":83,"keywords":87,"overallStatus":28,"whyStopped":24,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Skylark Bio Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Older","EXPERIMENTAL","Four subjects aged 2 to 7 years old (inclusive) to receive an intracochlear infusion of SKY-GJB2 in the study ear using a sterile, one-time use investigational medical device.",[13],"Combination Product: SKY-GJB2",{"label":15,"type":10,"description":16,"interventionNames":17},"Younger","Six subjects aged 9 months to less than 2 years old to receive an intracochlear infusion of SKY-GJB2 in the study ear using a sterile, one-time use investigational medical device.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"COMBINATION_PRODUCT","SKY-GJB2","SKY-GJB2 is intended to be administered via a one-time unilateral intracochlear infusion using the SKY-CAT delivery device.",[9,15],null,[26,45],{"facility":27,"status":28,"city":29,"state":30,"zip":31,"country":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Massachusetts Eye and Ear Infirmary (MEEI)","RECRUITING","Boston","Massachusetts","02114","United States",{"type":34,"coordinates":35},"Point",[36,37],-71.05977,42.35843,{"lat":37,"lon":36},[40],{"name":41,"role":42,"phone":43,"phoneExt":24,"email":44},"Michael Cheung, MSc, CCRP, Clinical Research Project Manager","CONTACT","617-573-6060","centerforclinicalresearchoperations@meei.harvard.edu",{"facility":46,"status":28,"city":47,"state":48,"zip":49,"country":32,"cosmosGeoPoint":50,"geoPoint":54,"contacts":55},"Lehigh Valley Hospital-Cedar Crest","Allentown","Pennsylvania","181103",{"type":34,"coordinates":51},[52,53],-75.49018,40.60843,{"lat":53,"lon":52},[56,60],{"name":57,"role":42,"phone":58,"phoneExt":24,"email":59},"Ravi N. Samy, MD, FACS","610-402-9543","Ravi.Samy@Jefferson.edu",{"name":61,"role":42,"phone":24,"phoneExt":24,"email":62},"Danielle Koehler, RN (Study Coordinator)","Danielle.Koehler@Jefferson.edu",{"type":64,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100642992",false,"NCT07627971","Open-label Study of SKY-GJB2 in Pediatric Subjects With GJB2-mediated Hearing Loss","A Phase 1\u002F2, Open-label, Single Dose Study of SKY-GJB2 Given as a Single Unilateral Intracochlear Administration in Pediatric Subjects With GJB2-mediated Hearing Loss","SONIX","Inclusion Criteria:\n\n* Male or female aged 9 months to 7 years at the time of gene therapy administration\n* Subjects must have at least two (biallelic) pathogenic or likely pathogenic variants in the GJB2 gene\n* Bilateral sensorineural hearing loss as assessed by ABR. Hearing loss at ≥85 dB HL for at least one of the frequencies (500-4000 Hz) in the study treatment ear.\n* Subject's parent(s)\u002Fguardian(s) provide informed consent before the initiation of study-related procedures.\n* Subject is able and willing to comply (or provide assent if old enough) will all study requirements.\n\nExclusion Criteria:\n\n* Subject has non-GJB2 mediated hearing loss including genetic, syndromic, or non-syndromic hearing loss that is not associated with GJB2 mutations.\n* Subject has autosomal dominant nonsyndromic hearing loss due to GJB2 mutation.\n* No response on ABR testing.\n* Bilateral Cochlear Implants.","ALL","9 Months","7 Years",{"count":76,"type":77},10,"ESTIMATED","INTERVENTIONAL",[80,81],"PHASE1","PHASE2","Skylark Bio is conducting a study of an investigational new drug called SKY-GJB2 and its delivery device, the SKY-CAT. SKY-GJB2 is a gene therapy that is being developed to treat children who have hearing loss due to changes in the GJB2 gene (also referred to as Connexin 26). The SKY-CAT is a device that delivers the gene therapy.\n\nThe purpose of this study is to:\n\nLearn about the safety and tolerability (does not cause ongoing discomfort) of SKY-GJB2 Evaluate the efficacy of SKY-GJB2 (how well is works)",[84,85,86],"GJB2-mediated Hearing Loss","GJB2 Gene Mutation","DFNB1A",[88,89,90,91,92,93],"GJB2","Hearing Loss, Bilateral","Hearing Loss","Hearing Loss, Sensorineural","Deafness, Autosomal Recessive 1A (DFNB1A)","Connexin 26","2026-06-25",{"date":96,"type":97},"2026-06-30","ACTUAL",{"date":99,"type":97},"2026-05-28",{"date":101,"type":77},"2028-06",{"name":5,"class":6},2]