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Clinical Trial Report

Gene Therapy Trial Report

Summary

An Investigator Initiated Study for OTOV101N+OTOV101C Injection


NCTID NCT05901480 (View at clinicaltrials.gov)
Description
Development Status Active
Indication DFNB9
Disease Ontology Term DOID:0110535
Compound Name OTOV101
Sponsor Otovia Therapeutics
Funder Type Industry
Recruitment Status
Recruiting
Enrollment Count 25
Results Posted Not Available

Therapy Information


Target Gene/Variant OTOF
Therapy Type Gene transfer
Therapy Route In-vivo
Mechanism of Action Functional gene replacement
Route of Administration Intracochlear
Drug Product Type Viral vector
Target Tissue/Cell Hair cell
Delivery System Viral transduction
Vector Type dual AAV
Editor Type
Dose 1 5.6E11 vg/AAV, 1.2E12 vg total
Dose 2
Dose 3
Dose 4
Dose 5

Study Record Dates


Current Stage Na
Submit Date 2023-05-09
Completion Date 2025-02-18
Last Update 2024-05-08

Participation Criteria


Eligible Age >=1 Year
Standard Ages Child, Adult, Older adult
Sexes Eligible for Study ALL

Locations


No.of Trial Sites 23
Locations China

Regulatory Information


Has US IND False
FDA Designations
Recent Updates

Resources/Links