NCT04601909

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 17, 2020

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

October 12, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 26, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2022

Completed
Last Updated

May 25, 2022

Status Verified

May 1, 2022

Enrollment Period

1.7 years

First QC Date

October 12, 2020

Last Update Submit

May 24, 2022

Conditions

PresbycusisHearing Loss, SensorineuralNoise Induced Hearing LossSudden Hearing Loss

Keywords

Intratympanic administrationRestoration of hearing loss

Outcome Measures

Primary Outcomes (4)

  • Systemic Safety: Number of patients with treatment-related adverse events

    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

    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

    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)

    Risk assessment through a series of simple, plain-language questions

    3 months

Secondary Outcomes (5)

  • Audiologic Response Endpoints: Speech Intelligibility - Word Recognition in Quiet (WR)

    3 months

  • Audiologic Response Endpoints: Speech Intelligibility - Words-In-Noise (WIN)

    3 months

  • Standard Pure Tone Audiometry

    3 months

  • Extended High Frequency Pure Tone Audiometry

    3 months

  • Tinnitus Assessment

    3 months

Study Arms (2)

FX-322

ACTIVE COMPARATOR

FX-322, 1 dose (N=24)

Drug: FX-322

Placebo

PLACEBO COMPARATOR

Placebo, 1 dose (n=6)

Other: placebo

Interventions

FX-322DRUG

active comparator

FX-322
placeboOTHER

placebo

Placebo

Eligibility Criteria

Age66 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Subject has previously participated in a FX-322 clinical trial.
  • 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.
  • Clinically significant abnormalities on safety laboratory tests.
  • 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 visit or on the prior audiogram (if the Investigator feels there is not a true conductive hearing loss, the Medical Monitor should be consulted).
  • Active chronic middle ear disease or a history of major middle ear surgery, as an adult, in the ear to be injected.
  • Subject has had an intratympanic injection in either ear within 3 months of the screening visit.
  • History of clinically significant vestibular symptoms at the discretion of the investigator. For example, BPPV may be considered acceptable whereas Meniere's would not.
  • History of clinically significant systemic autoimmune disease (e.g. rheumatoid arthritis, Sjogren's syndrome, multiple sclerosis, psoriasis).
  • Exposure to another investigational drug within 28 days prior to injection of study drug.
  • 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).
  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Clinical Trial Site

Sarasota, Florida, 00000, United States

Location

Clinical Trial Site

Omaha, Nebraska, 00000, United States

Location

Clinical Trial Site

Amherst, New York, 00000, United States

Location

Clinical Trial Site

San Antonio, Texas, 00000, United States

Location

Clinical Trial Site

Norfolk, Virginia, 00000, United States

Location

MeSH Terms

Conditions

PresbycusisHearing Loss, SensorineuralHearing Loss, Noise-InducedHearing Loss, Sudden

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Carl LeBel, PhD

    Frequency Therapeutics

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double-blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Approximately 30 subjects are planned to be enrolled in this study. The subjects will be randomized to receive FX-322 or placebo randomized 4:1.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2020

First Posted

October 26, 2020

Study Start

September 17, 2020

Primary Completion

May 16, 2022

Study Completion

May 16, 2022

Last Updated

May 25, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

US(5)