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Safety, Tolerability, Efficacy of EA0010 in OTOF Patients With CI

NCT07752888 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2026-08-12

No results posted yet for this study

Summary

This study will evaluate the safety, tolerability, and efficacy of EA0010 injection in patients with OTOF-related hearing loss who have already undergone cochlear implantation. Conventional gene therapy generally excludes cochlear implant recipients, based on the concern that the electrode array may compromise the reparative potential of inner ear cells. To further address this clinical issue, the present study is designed to enroll cochlear implant users and administer a single intratympanic injection of EA0010 through the stapes annular ligament into the implanted cochlea. One subject is planned to be enrolled, and post-administration assessments of both safety and efficacy will be performed.

Conditions

  • DFNB9
  • Cochlear Implantation

Interventions

GENETIC

EA0010 Injection

EA0010 is an investigational gene therapy product comprising two adeno-associated virus (AAV) vectors carrying OTOF gene sequences. The two components (Solution A and Solution B) are mixed at a 1:1 ratio immediately prior to administration. Dose and Administration: Participants will receive a single dose of 2.0 × 10\^11 viral genomes (vg) per ear. The total injection volume will range from 10 to 40 μL, adjusted based on the actual viral titer of the manufactured batch. Administration: Single unilateral intratympanic injection via the stapes annular ligament. Pre-medication: Systemic glucocorticoid therapy will be initiated 3 days prior to surgery (Day -3) to mitigate potential inflammation.

Sponsors & Collaborators

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    collaborator OTHER

  • Shanghai EmayGene Technology Co., Ltd

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2026-05-23
Primary Completion
2027-05-31
Completion
2027-07-31

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 NCT07752888 on ClinicalTrials.gov