Trials / Completed

CompletedNCT05086276

FX-322 in Adults With Acquired Sensorineural Hearing Loss

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

Status: Completed
Phase: Phase 2
Study type: Interventional
Enrollment: 142 (actual)

Sponsor: Frequency Therapeutics · Industry
Sex: All
Age: 18 Years – 65 Years
Healthy volunteers: Not accepted

Summary

Detailed 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.

Conditions

Interventions

Type	Name	Description
DRUG	FX-322	Active Comparator
DRUG	Placebo	Placebo

Timeline

Start date: 2021-10-12
Primary completion: 2022-12-30
Completion: 2022-12-30
First posted: 2021-10-20
Last updated: 2023-04-21
Results posted: 2023-04-21

Locations

26 sites across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT05086276. Inclusion in this directory is not an endorsement.