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FX-322 in Adults With Acquired Sensorineural Hearing Loss

NCT05086276 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2023-04-21

Study results available
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Summary

This is a Phase 2, prospective, randomized, double-blind, placebo-controlled, single-dose, multicenter study to evaluate the efficacy of FX-322, administered by intratympanic injection, in adults with acquired sensorineural hearing loss (SNHL).

Conditions

  • Hearing Loss, Sensorineural
  • Noise Induced Hearing Loss
  • Sudden Hearing Loss

Interventions

DRUG

FX-322

Active Comparator

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Frequency Therapeutics

    lead INDUSTRY

Principal Investigators

  • Carl LeBel, PhD · Frequency Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-12
Primary Completion
2022-12-30
Completion
2022-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05086276 on ClinicalTrials.gov