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FX-322 in Sensorineural Hearing Loss

NCT03616223 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2022-11-14

Study results available
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Summary

This is a phase 1/2 study of FX-322 at two dose levels compared to placebo in male and female adults otherwise healthy with stable sensorineural hearing loss.

Conditions

  • Sensorineural Hearing Loss

Interventions

DRUG

FX-322

Intratympanic injection of FX-322 consists of laduviglusib and sodium valproate

DRUG

Placebo

Intratympanic injection

Sponsors & Collaborators

  • Frequency Therapeutics

    lead INDUSTRY

Principal Investigators

  • George Atiee, MD · Worldwide Clinical Trials

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
2018-07-03
Primary Completion
2018-12-18
Completion
2018-12-18
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 NCT03616223 on ClinicalTrials.gov