FX-322 in Adults With Stable Sensorineural Hearing Loss

Summary

This is a phase 2a single and repeat dose exploratory efficacy study of intratympanic FX-322 compared to placebo in healthy male and female adults with stable sensorineural hearing loss.

Timeline

Start

2019-10-04

Primary completion

2020-10-06

Completion

2020-12-17

Outcome

Missed primary endpoint

registry analysis (superiority test); FX-322 Pooled vs Group 4: Placebo Four Doses; p = 0.068; Odds Ratio (OR) 0.3 (95% CI 0.11 to 1.08) NCT04120116 ↗

registry analysis (superiority test); FX-322 Pooled vs Group 4: Placebo Four Doses; p = 0.634; Least squares mean difference 1.25 (95% CI -3.945 to 6.439) NCT04120116 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	FX-322	Unknown	—	Other

Indications