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An Investigator Initiated Study for OTOV101N+OTOV101C Injection

NCT05901480 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2024-05-08

No results posted yet for this study

Summary

This study is an investigator initiated study to evaluate the safety, tolerability, and efficacy of OTOV101N+OTOV101C injection in treating patients with OTOF mutation-related deafness. The enrolled subjects who meet the inclusion and exclusion criteria will receive the gene therapy of OTOV101N+OTOV101C injection via intracochlear injection. All participants will return to the hospital for safety and efficacy evaluations at predetermined time points defined by protocol during the study (Week 1 ± 1 Day, Week 2 ± 3 Days, Week 3 ± 3 Days, Month 1 ± 3 Days, Month 2 ± 3 Days, Month 4 ± 6 Days, Month 6 ± 6 Days, Month 9 ± 6 Days, Month 12 ± 6 Days/EOS (end of study)/unscheduled visit).

Conditions

  • DFNB9

Interventions

GENETIC

OTOV101N+OTOV101C Injections

The gene therapy of OTOV101N+OTOV101C injection via intracochlear injection.

Sponsors & Collaborators

  • Otovia Therapeutics

    lead INDUSTRY

Principal Investigators

  • Shanzhong Zhang, MD PhD · Otovia Therapeutics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-26
Primary Completion
2024-12-06
Completion
2025-02-18

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05901480 on ClinicalTrials.gov