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

NCT07288580 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-04-14

No results posted yet for this study

Summary

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.

Conditions

  • Treatment of Congenital Hearing Loss Secondary to Biallelic Mutations of the Otoferlin Gene (OTOF)

Interventions

DRUG

EHT102 Injection

EHT102 injection is a dual-vector gene therapy product developed for the treatment of OTOF-related hearing loss.

Sponsors & Collaborators

  • Shanghai Euhearing Therapeutics Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Yilai Shu, M.D. & Ph.D. · Eye & ENT Hospital of Fudan University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
1 Year
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-02
Primary Completion
2028-06-30
Completion
2033-12-30
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07288580 on ClinicalTrials.gov