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First in Human Safety Study of FX-322 in Adults Undergoing Cochlear Implantation

Hearing Loss Clinical Trial

Official title:
First in Human Safety Study of FX-322 in Adults Undergoing Cochlear Implantation

Clinical Trial Summary

This is a phase 1 safety study performed in male or female adult participants with an established diagnosis of severe to profound sensorineural hearing loss that meets the criteria for cochlear implantation and the participant has already chosen to undergo cochlear implant surgery.

Clinical Trial Description

Approximately 12 participants will be enrolled in the study. Assessed will be safety and tolerability of FX-322 administered by intratympanic injection. Also assessed will be the FX-322 concentration in cochlear fluid (perilymph), the pharmacokinetic (PK) profile of FX-322 to determine the systemic exposure to FX-322. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03300687
Study type Interventional
Source Frequency Therapeutics
Contact
Status Completed
Phase Early Phase 1
Start date May 30, 2017
Completion date January 18, 2018
View Details
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