First in Human Safety Study of FX-345 in Adults With Sensorineural Hearing Loss

Summary

This single-blind, placebo-controlled trial will be conducted to evaluate the safety of FX-345 administered as a single intratympanic injection in adults with acquired sensorineural hearing loss. The primary objectives are to assess the local safety, systemic safety, and pharmacokinetic (PK) profile to determine systemic exposure.

Timeline

Start

2022-12-15

Primary completion

2023-04-12

Completion

2023-04-12

Outcome

Outcome not reported

Stopped (Business): “Business reasons”

Drugs

Indications