Hearing Loss, Sensorineural Clinical Trial
Official title:
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
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).
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. ;
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