clinical trial · NCT05821959
Gene Therapy Trial for Otoferlin Gene-mediated Hearing Loss
Akouos, Inc.·phase2·recruiting·n = 22
Sensorineural Hearing Loss, BilateralAAVAnc80-hOTOF via Akouos Delivery DeviceAAVAnc80-hOTOF via Akouos Delivery Device and Precision Delivery Mechanism
brief 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.
started
Sep 15, 2023
primary completion
Oct 1, 2028
completion
Oct 1, 2028
last updated
Mar 4, 2026
detailed description
The following two dose levels will be tested:
* Up to 4.1E11 total vg/cochlea * Up to 8.1E11 total vg/cochlea
official title
A Trial of AAVAnc80-hOTOF Gene Therapy in Individuals With Sensorineural Hearing Loss Due to Otoferlin Gene Mutations
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol