NCT04629664

FX-322 in Adults With Severe Sensorineural Hearing Loss

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Frequency Therapeutics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Hearing Loss, Sensorineural
• Noise Induced Hearing Loss
• Sudden Hearing Loss

Interventions

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

Timeline

• Start date: 2020-11-02
• Primary completion: 2021-05-26
• Completion: 2021-09-20
• First posted: 2020-11-16
• Last updated: 2022-02-01

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study