Clinical Trial

Open-label Study of SKY-GJB2 in Pediatric Subjects With GJB2-mediated Hearing Loss

Study acronym: SONIX
Recruiting Phase 1/2
View on ClinicalTrials.gov →
Summary
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. The purpose of this study is to: Learn about the safety and tolerability (does not cause ongoing discomfort) of SKY-GJB2 Evaluate the efficacy of SKY-GJB2 (how well is works)
Protocol Amendment History 6 changes
critical Trial status changed: Withheld → Recruiting 2026-06-11
critical Phase changed: not specified -> Phase 1/2 2026-06-11
critical Primary endpoint(s) modified 2026-06-11
notable Enrollment changed: None -> 10 2026-06-11
notable Sponsor changed: [Redacted] -> Skylark Bio Inc. 2026-06-11
minor Trial arms changed: 0 -> 2 2026-06-11
Trial Details
NCT Number NCT07627971
Lead Sponsor Skylark Bio Inc.
Conditions GJB2-mediated Hearing Loss, GJB2 Gene Mutation, DFNB1A
Enrollment 10 participants
Start Date 2026-05-28
Primary Completion 2027-12 (estimated)
Study Completion 2028-06 (estimated)
Updated on ClinicalTrials.gov 2026-07-15