Current Research Studies

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

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?

Please contact the study team listed below to learn more.

Study Team: