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

May 24, 2022 updated by: Frequency Therapeutics

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

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.

Study Overview

Detailed Description

This is a Phase 1b placebo-controlled, double-blind, randomized, single-dose safety study of intratympanic FX-322 dosed in subjects with age-related sensorineural hearing loss.

Approximately 30 subjects are planned to be enrolled in this study. The subjects will be randomized to receive one dose FX-322 (24) or placebo (6) and will return for safety, otologic, and audiologic assessments at Days 30 and 90 after the study injection.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Florida
      • Sarasota, Florida, United States, 00000
        • Clinical Trial Site
    • Nebraska
      • Omaha, Nebraska, United States, 00000
        • Clinical Trial Site
    • New York
      • Amherst, New York, United States, 00000
        • Clinical Trial Site
    • Texas
      • San Antonio, Texas, United States, 00000
        • Clinical Trial Site
    • Virginia
      • Norfolk, Virginia, United States, 00000
        • Clinical Trial Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

66 years to 85 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subject has read and voluntarily signed the Informed Consent Form (ICF) after all questions have been answered and prior to any study-mandated procedure.
  2. Adult aged 66-85 years inclusive.
  3. Documented medical history consistent with age-related sensorineural hearing loss (documented audiogram at least 6 months prior to screening required).
  4. A pure tone average of 26-70 dB at 500Hz, 1000Hz, 2000Hz, and 4000Hz at Screening in the ear to be injected.
  5. Ability to communicate well with the Investigator and is willing to comply with and complete all the study procedures.

Exclusion Criteria:

  1. Subject has previously participated in a FX-322 clinical trial.
  2. Any subject with a flat audiogram between 500Hz and 8000Hz at Screening in the study ear. The difference in the range of threshold values across frequencies is ≤15 dB for the definition of a flat audiogram.
  3. Clinically significant abnormalities on safety laboratory tests.
  4. 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.
  5. 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 visit or on the prior audiogram (if the Investigator feels there is not a true conductive hearing loss, the Medical Monitor should be consulted).
  6. Active chronic middle ear disease or a history of major middle ear surgery, as an adult, in the ear to be injected.
  7. Subject has had an intratympanic injection in either ear within 3 months of the screening visit.
  8. History of clinically significant vestibular symptoms at the discretion of the investigator. For example, BPPV may be considered acceptable whereas Meniere's would not.
  9. History of clinically significant systemic autoimmune disease (e.g. rheumatoid arthritis, Sjogren's syndrome, multiple sclerosis, psoriasis).
  10. Exposure to another investigational drug within 28 days prior to injection of study drug.
  11. Evidence of any active or chronic disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would pose an unacceptable risk to the subject in the opinion of the investigator following a detailed medical history, physical examination, and vital signs (systolic and diastolic blood pressure, pulse rate, body temperature).
  12. Females of childbearing potential (those who are not surgically sterilized or post-menopausal) may not participate in the study if any of the following conditions exist:

    • Pregnant or intend to become pregnant
    • Nursing (lactating)
    • Does not agree to use adequate birth control methods for the duration of the study (adequate birth control methods are: hormonal- oral, implantable, transdermal or injectable contraceptives; mechanical- spermicide in conjunction with a barrier such as a condom or diaphragm, IUD, or surgical sterilization of a partner.

    NOTE: all female subjects of childbearing potential must consent to a urine pregnancy test as described in the Schedule of Assessments

  13. Any known factor, condition, or disease that, in the view of the Investigator, might interfere with treatment compliance, study conduct or interpretation of the results (e.g. previous high-dose aminoglycoside treatment).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: FX-322
FX-322, 1 dose (N=24)
active comparator
Placebo Comparator: Placebo
Placebo, 1 dose (n=6)
placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systemic Safety: Number of patients with treatment-related adverse events
Time Frame: 3 months
Number of patients with treatment-related adverse events assessed by CTCAE v5.0
3 months
Local Safety: Number of patients with abnormal changes from baseline in otoscopic examinations
Time Frame: 3 months
Microscopic otoscopy will be included to specifically record any abnormalities of the external ear canal, tympanic membrane and middle ear.
3 months
Local Safety: The number of patients with abnormal changes from baseline in tympanometry
Time Frame: 3 months
Tympanometry tests the integrity of the tympanic membrane by varying air pressure in the ear canal. Middle ear compliance (mL), peak pressure (daPa), and ear canal volume (mL) will be recorded.
3 months
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time Frame: 3 months
Risk assessment through a series of simple, plain-language questions
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Audiologic Response Endpoints: Speech Intelligibility - Word Recognition in Quiet (WR)
Time Frame: 3 months
Assessment of speech intelligibility using the Word Recognition in Quiet test measured with Consonant-Nucleus-Consonant (CNC) word lists.
3 months
Audiologic Response Endpoints: Speech Intelligibility - Words-In-Noise (WIN)
Time Frame: 3 months
Speech intelligibility using the Words-in-Noise test measured with Consonant-Nucleus-Consonant (CNC) word lists
3 months
Standard Pure Tone Audiometry
Time Frame: 3 months
Standard pure tone audiometry will be measured to determine a subject's threshold for hearing at standard frequencies (Hz)
3 months
Extended High Frequency Pure Tone Audiometry
Time Frame: 3 months
Pure tone audiometry will be measured to determine a subject's threshold for hearing at extended high range frequencies (Hz)
3 months
Tinnitus Assessment
Time Frame: 3 months
Measured by the Tinnitus Functional Index (TFI), with a scale ranging from 0 to 100 that defines severity categories based on 25 self-reported answers.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Carl LeBel, PhD, Frequency Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 17, 2020

Primary Completion (Actual)

May 16, 2022

Study Completion (Actual)

May 16, 2022

Study Registration Dates

First Submitted

October 12, 2020

First Submitted That Met QC Criteria

October 20, 2020

First Posted (Actual)

October 26, 2020

Study Record Updates

Last Update Posted (Actual)

May 25, 2022

Last Update Submitted That Met QC Criteria

May 24, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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