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First in Human Safety Study of FX-345 in Adults With Sensorineural Hearing Loss

Hearing Loss, Sensorineural Clinical Trial

Official title:
A Phase 1b, Prospective, Randomized, Single-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety of FX-345 Administered as a Single Intratympanic Injection in Adults With Acquired Adult-Onset Sensorineural Hearing Loss

Clinical Trial Summary

This single-blind, placebo-controlled trial will be conducted to evaluate the safety of FX-345 administered as a single intratympanic injection in adults with acquired sensorineural hearing loss. The primary objectives are to assess the local safety, systemic safety, and pharmacokinetic (PK) profile to determine systemic exposure.

Clinical Trial Description

This study will enroll two cohorts. Cohort 1 (n=9) will be enrolled first to rapidly assess safety and drug exposure. After the sponsor completes an unblinded safety review, Cohort 2 (n=27) will be enrolled to continue safety evaluation of FX-345. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05664100
Study type Interventional
Source Frequency Therapeutics
Contact
Status Terminated
Phase Phase 1
Start date December 15, 2022
Completion date April 12, 2023
View Details
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