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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

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Trial Profile

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

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 23 Jul 2025

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At a glance

  • Drugs DB XX2 (Primary)
  • Indications Sensorineural hearing loss
  • Focus Adverse reactions; First in man
  • Acronyms CHORD
  • Sponsors Regeneron Pharmaceuticals

Most Recent Events

  • 11 Jul 2025 Planned number of patients changed from 22 to 30.
  • 11 Jul 2025 Addition of 1 Primary endpoint (Achievement of a hearing sensitivity threshold assessed by average pure tone audiometry (PTA).)
  • 24 Feb 2025 According to a Regeneron Pharmaceuticals Media Release, results of this trial were presented in an oral presentation at the Association for Research in Otolaryngology's (ARO) 48th Annual MidWinter Meeting.

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