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FX-322 in Adults With Age-Related Sensorineural Hearing Loss

NCT04601909 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-05-25

No results posted yet for this study

Summary

This is a Phase 1b, prospective, randomized, double-blind, placebo-controlled, single-dose, multicenter, safety study of FX-322, administered by intratympanic injection, in adults with age-related sensorineural hearing loss.

Conditions

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

Interventions

DRUG

FX-322

active comparator

OTHER

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
66 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-17
Primary Completion
2022-05-16
Completion
2022-05-16
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT04601909 on ClinicalTrials.gov