NCT03616223

FX-322 in Sensorineural Hearing Loss

A Phase 1/2 Randomized, Double-blind, Placebo-controlled Single Dose Study at Two Dose Levels of FX-322 Administered by Intratympanic Injection in Adults With Stable Sensorineural Hearing Loss

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Frequency Therapeutics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 1/2 study of FX-322 at two dose levels compared to placebo in male and female adults otherwise healthy with stable sensorineural hearing loss.

Detailed description

Sensorineural hearing loss (SNHL) accounts for about 90% of all cases of hearing loss. The study will assess the safety of FX-322 (laduviglusib and sodium valproate) given as a single intratympanic injection in subjects with a medical history of sensorineural hearing loss that is associated with noise exposure or sudden hearing loss. Safety will be evaluated both systemically (lab and clinical monitoring) and locally (otoscopy and audiometry) in 24 subjects, and a blood PK profile of FX-322 will also be determined.

Conditions

• Sensorineural Hearing Loss

Interventions

Type	Name	Description
DRUG	FX-322	Intratympanic injection of FX-322 consists of laduviglusib and sodium valproate
DRUG	Placebo	Intratympanic injection

Timeline

• Start date: 2018-07-03
• Primary completion: 2018-12-18
• Completion: 2018-12-18
• First posted: 2018-08-06
• Last updated: 2022-11-14
• Results posted: 2022-11-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study