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Clinical trial

A Phase 1/2, Open-Label, Multicenter Trial With a Single Ascending Dose Cohort With Unilateral Intracochlear Injection Followed by a Bilateral Injection Expansion Cohort to Evaluate the Safety, Tolerability, and Efficacy of DB-OTO in Children and Infants With Biallelic hOTOF Mutations

NCT05788536 is registered in ClinicalTrials.gov with Regeneron Pharmaceuticals as lead sponsor.

NCT NCT05788536
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Registry record

As filed in ClinicalTrials.gov.

Title
A Phase 1/2, Open-Label, Multicenter Trial With a Single Ascending Dose Cohort With Unilateral Intracochlear Injection Followed by a Bilateral Injection Expansion Cohort to Evaluate the Safety, Tolerability, and Efficacy of DB-OTO in Children and Infants With Biallelic hOTOF Mutations
Lead sponsor
Regeneron Pharmaceuticals
Phase
Phase 1/2
Overall status
Recruiting
Start date
June 27, 2023
Completion date
February 25, 2032
Enrollment
36 (estimated)
Sites
17

Conditions

As the registry lists them; a condition with its own page is linked.

congenital hearing loss secondary to biallelic mutations of the otoferlin gene (otof)