First in Human Safety Study of FX-345 in Adults With Sensorineural Hearing Loss
Status:
Recruiting
Trial end date:
2023-10-01
Target enrollment:
Participant gender:
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.