RecruitingPhase 1Phase 2NCT05821959

Gene Therapy Trial for Otoferlin Gene-mediated Hearing Loss

A Trial of AAVAnc80-hOTOF Gene Therapy in Individuals With Sensorineural Hearing Loss Due to Otoferlin Gene Mutations

Sponsor

Akouos, Inc.

Enrollment

22 participants

Start Date

Sep 15, 2023

Study Type

INTERVENTIONAL

Conditions

Sensorineural Hearing Loss, Bilateral

Summary

Part A of this trial will evaluate the safety and tolerability of a single surgical administration procedure in one or both ear(s) with one of two dose levels of AAVAnc80-hOTOF and will evaluate the Akouos Delivery Device, together with the Precision Delivery Mechanism, to safely achieve the intended product performance.

Eligibility

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying AAVAnc80-hOTOF via Akouos Delivery Device and AAVAnc80-hOTOF via Akouos Delivery Device and Precision Delivery Mechanism for people with sensorineural hearing loss, bilateral. The study is currently recruiting participants at 9 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTAAVAnc80-hOTOF via Akouos Delivery Device

AAVAnc80-hOTOF is a sterile suspension intended to be administered via a one-time unilateral intracochlear administration using the Akouos Delivery Device.

COMBINATION_PRODUCTAAVAnc80-hOTOF via Akouos Delivery Device and Precision Delivery Mechanism

AAVAnc80-hOTOF is a sterile suspension intended to be administered via a one-time bilateral intracochlear administration using the Akouos Delivery Device together with the Precision Delivery Mechanism.