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FX-322 in Adults With Stable Sensorineural Hearing Loss

NCT04120116 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2023-04-27

Study results available
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Summary

This is a phase 2a single and repeat dose exploratory efficacy study of intratympanic FX-322 compared to placebo in healthy male and female adults with stable sensorineural hearing loss.

Conditions

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

Interventions

DRUG

FX-322 (One Dose)

Patients will receive one dose of FX-322.

DRUG

FX-322 (Two Doses)

Patients will receive two doses of FX-322.

DRUG

FX-322 (Four Doses)

Patients will receive four doses of FX-322.

DRUG

Placebo

Patients will receive 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
2019-10-04
Primary Completion
2020-10-06
Completion
2020-12-17
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 NCT04120116 on ClinicalTrials.gov