A Clinical Trial of EHT102 Injection in Pediatric Patients With Biallelic hOTOF Mutations

This study is a multicenter, single-arm, open-label Phase I/II clinical trial, which is designed to evaluate the safety, tolerability and efficacy of EHT102 injection in treating congenital hearing loss secondary to biallelic mutations of OTOF (DFNB9).Up to 30 pediatric participants (A maximum of 15 participants will be enrolled in each of the United States and China) will be enrolled and dosed with EHT102. The dose-escalation phase (Phase I) includes two predefined dose cohorts (3 participants per cohort), with sequential enrollment from low to high dose. During dose escalation, each participant will receive a unilateral EHT102 injection followed by safety observation.

NCT Number	NCT07288580
Lead Sponsor	Shanghai Euhearing Therapeutics Co., Ltd
Conditions	Treatment of Congenital Hearing Loss Secondary to Biallelic Mutations of the Otoferlin Gene (OTOF)
Enrollment	30 participants
Start Date	2026-04-02
Primary Completion	2028-06-30 (estimated)
Study Completion	2033-12-30 (estimated)
Updated on ClinicalTrials.gov	2026-04-14