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Study identifier: NCT07627971 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: GJB2-mediated Hearing Loss · GJB2 Gene Mutation · DFNB1A  ·  Sponsor: Skylark Bio Inc.

PhasePhase 1/Phase 2
Planned participants10
Who can joinAll sexes, 9 Months to 7 Years
Healthy volunteersNo

About this study

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)

This description comes directly from the study's public registry record.

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Contact details are listed per location below or on the registry record.

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Locations (3)

Massachusetts Eye and Ear Infirmary (MEEI)Boston, Massachusetts, United StatesRecruiting
Hearts for Hearing-Oklahoma CityOklahoma City, Oklahoma, United StatesRecruiting
Lehigh Valley Hospital-Cedar CrestAllentown, Pennsylvania, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT07627971