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Gene Therapy Trial for Otoferlin Gene-mediated Hearing Loss

Sensorineural Hearing Loss, Bilateral Clinical Trial

Official title:
A Phase 1/2 Trial of AAVAnc80-hOTOF Gene Therapy in Individuals With Sensorineural Hearing Loss Due to Biallelic Otoferlin Gene Mutations

Clinical Trial Summary

Part A of this trial will evaluate the safety and tolerability of a single unilateral administration of one of two dose levels of AAVAnc80-hOTOF and will evaluate the Akouos delivery device to safely achieve the intended product performance.

Clinical Trial Description

The following two dose levels will be tested sequentially: - 4.1E11 total vg/cochlea - 8.1E11 total vg/cochlea ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05821959
Study type Interventional
Source Akouos, Inc.
Contact Akouos Clinical Trials
Phone +1 (857) 410-1816
Email clinicaltrials@akouos.com
Status Recruiting
Phase Phase 1/Phase 2
Start date September 15, 2023
Completion date October 2028
View Details
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