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First received: December 13, 2022

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

Study Status: Active, not recruiting

Recruit Status: Active, not recruiting

Condition: Hearing Loss, Sensorineural

Study Type: Interventional


Official Title: A Phase 1b, Prospective, Randomized, Single-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety of FX-345 Administered as a Single Intratympanic Injection in Adults With Acquired Adult

Brief 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.

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