FX-322 in Adults With Acquired Sensorineural Hearing Loss

  • STATUS
    Not Recruiting
  • participants needed
    124
  • sponsor
    Frequency Therapeutics
Updated on 29 November 2022
sensorineural hearing loss
hard of hearing
audiogram

Summary

This is a Phase 2, prospective, randomized, double-blind, placebo-controlled, single-dose, multicenter study to evaluate the efficacy of FX-322, administered by intratympanic injection, in adults with acquired sensorineural hearing loss (SNHL).

Description

This is a Phase 2, prospective, randomized, double-blind, placebo-controlled, single-dose, multicenter study to evaluate the efficacy of FX-322, administered by intratympanic injection, in adults with acquired sensorineural hearing loss (SNHL).

Previous human studies in subjects 18 to 65 years inclusive (FX-322-103, FX-322-201, FX-322-111) and subjects 66-85 inclusive (FX-322-112) demonstrated that a single dose FX-322 was well tolerated in patients with acquired SNHL with no treatment-related serious adverse events. Adverse events in these studies were generally common to and associated with the intratympanic injection procedure with mild and transient discomfort in patients both with the drug and the placebo.

Frequency Therapeutics' Investigators intend to evaluate efficacy with a single dose of FX-322 in subjects 18 to 65 years inclusive with acquired SNHL.

Details
Condition Hearing Loss, Sensorineural, Noise Induced Hearing Loss, Sudden Hearing Loss
Treatment Placebo, FX-322
Clinical Study IdentifierNCT05086276
SponsorFrequency Therapeutics
Last Modified on29 November 2022

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