NCT05664100

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

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-Onset Sensorineural Hearing Loss

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Frequency Therapeutics · Industry
• Sex: All
• Age: 18 Years – 67 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study will enroll two cohorts. Cohort 1 (n=9) will be enrolled first to rapidly assess safety and drug exposure. After the sponsor completes an unblinded safety review, Cohort 2 (n=27) will be enrolled to continue safety evaluation of FX-345.

Conditions

• Hearing Loss, Sensorineural

Interventions

Type	Name	Description
DRUG	FX-345	Single intratympanic injection of FX-345
DRUG	Placebo	Single intratympanic injection of placebo

Timeline

• Start date: 2022-12-15
• Primary completion: 2023-04-12
• Completion: 2023-04-12
• First posted: 2022-12-23
• Last updated: 2023-04-27

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study