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First in Human Safety Study of FX-345 in Adults With Sensorineural Hearing Loss | Clinical Trials | Clareo Health

TERMINATEDPHASE1

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

NCT05664100•Frequency Therapeutics

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 67 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Adult aged 18-67 years (inclusive)
•Documented medical history consistent with acquired, adult onset, sensorineural hearing loss
•At the Screening, Lead-in (Visit 2) and Treatment (Day 1) Visits, a pure tone average of 40- 80 dBHL at 500Hz, 1000Hz, 2000Hz, and 4000Hz in the potential study ear to be injected
•Female participants must not be pregnant, breastfeeding, or lactating. Women of child-bearing potential must agree to use a highly effective contraceptive method and must have a negative urine pregnancy test.
•Male participants must refrain from donating sperm and agree to be either abstinent or use a barrier method of contraception

Exclusion Criteria

•Randomization in a FX-322 (laduviglusib and sodium valproate) clinical trial
•Perforation of tympanic membrane or other tympanic membrane disorders that would interfere with the delivery and safety assessment of an intratympanic medication or reasonably be suspected to affect tympanic membrane healing after injection in study ear. This includes a current tympanostomy tube.
•Any conductive hearing loss of greater than 15 dB at a single frequency or greater than 10 dB at two or more contiguous octave frequencies in the study ear at the Screening, Lead-in (Visit 2) or Treatment (Day 1) Visits, based on the investigator's judgment.
•Active chronic middle ear disease or a history of major middle ear surgery, as an adult, in the ear to be injected.
•Within 3 months of screening visit any of the following: 1) an intratympanic injection in either ear 2) treatment with steroids 3) onset of sudden sensorineural hearing loss
•Evidence of or previous diagnosis of traumatic brain injury, Meniere's disease, or genetic hearing loss
•History of head or neck radiation, significant systemic autoimmune disease, and/or chronic, recurrent clinically significant vestibular symptoms
•Exposure to another investigational drug within 28 days prior to screening visit

Locations (4)

Clinical Trial Site

Sarasota, Florida, United States

Clinical Trial Site

Spartanburg, South Carolina, United States

Clinical Trial Site

San Antonio, Texas, United States

Clinical Trial Site

San Antonio, Texas, United States

Key Dates

Start Date

December 15, 2022

Primary Completion Date

April 12, 2023

Completion Date

April 12, 2023

Last Updated

April 27, 2023

Enrollment

ACTUAL participants

Conditions

Hearing Loss, Sensorineural

Interventions

FX-345

DRUG

Placebo

DRUG

Preschool Hearing Screening

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Hearing LossHearing Disorders in Children+6 more

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RECRUITINGNA

A Study to Explore Improved Features and a Simplified Treatment Approach for a Totally Implantable Cochlear Implant (TICI) Research System in Adults With Severe Hearing Loss

NCT06642935

Hearing Loss, Bilateral or UnilateralHearing Loss, Sensorineural+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 27, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Preschool Hearing Screening

A Study to Explore Improved Features and a Simplified Treatment Approach for a Totally Implantable Cochlear Implant (TICI) Research System in Adults With Severe Hearing Loss

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