Clinical Trial Search block Test

A Phase ½, Open-Label, Multicenter Trial with a Single Ascending Dose Cohort with Unilateral Intracochlear Injection Followed by Bilateral Injection Expansion Cohort to Evaluate the Safety, Tolerability, and Efficacy of DB-OTO in Children and Infants with Biallelic hOTOF Mutations

DB-OTO-001_Rubinstein_Phase 1/2

  • Condition(s): Other
  • Phase: Early Phase I

What is the goal of the study?

This is a multicenter international phase 1/2, open-label, 2-part trial with a single-ascending dose patient cohort (Part A) and a bilateral expansion patient cohort (Part B) to evaluate the safety, tolerability, and preliminary efficacy of DB-OTO in in young children and infants diagnosed with biallelic otoferlin gene (hOTOF) mutations.

Who can participate in the study?

Everyone

Study Team: