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Clinical Trial Summary

This is a Phase 1b, prospective, randomized, double-blind, placebo-controlled, single-dose, multicenter, safety study of FX-322, administered by intratympanic injection, in adults with severe sensorineural hearing loss.


Clinical Trial Description

This is a Phase 1b placebo-controlled, double-blind, single-dose safety study of intratympanic FX-322 dosed in subjects with severe sensorineural hearing loss. Approximately 30 subjects are planned to be enrolled in this study. The subjects will be randomized to receive one dose FX-322 (24) or placebo (6) and will return for safety, otologic, and audiologic assessments at Days 30 and 90 after the study injection. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04629664
Study type Interventional
Source Frequency Therapeutics
Contact
Status Completed
Phase Phase 1
Start date November 2, 2020
Completion date September 20, 2021

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