FX-322 in Adults With Severe Sensorineural Hearing Loss

NCT04629664 | Completed Phase 1 FDA Drug

• 1 other identifier: FX-322-113
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 7

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 severe sensorineural hearing loss.

Conditions

Hearing Loss, Sensorineural; Noise Induced Hearing Loss; Sudden Hearing Loss

Keywords

Intratympanic administration; Restoration 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: Speech Intelligibility - Bamford-Kowal-Bench Speech in Noise (BKB-SIN)

  3 months

• Standard Pure Tone Audiometry

  3 months

• Extended High Frequency Pure Tone Audiometry

  3 months

• Tinnitus Assessment

  2 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-322 DRUG

Active Comparator

FX-322

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older 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 18-65 years inclusive.
• Documented medical history consistent with acquired (non-genetic) severe sensorineural hearing loss (documented audiogram at least 6 months prior to screening required).
• A pure tone average of 71-90 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.
• 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.
• NOTE: all female subjects of childbearing potential must consent to a urine pregnancy test as described in the Schedule of Assessments. Male subjects should use condoms with spermicide during the study or remain abstinent. Subjects should not donate sperm or ova during the study period.
• 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.

Sponsors & Collaborators

• Frequency Therapeutics: lead

Study Sites (7)

Clinical Trial Site

Novi, Michigan, 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

Orangeburg, South Carolina, 00000, United States

Location

Clinical Trial Site - San Antonio #1

San Antonio, Texas, 00000, United States

Location

Clinical Trial Site - San Antonio #2

San Antonio, Texas, 00000, United States

Location

Clinical Trial Site

Norfolk, Virginia, 00000, United States

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural; Hearing Loss, Noise-Induced; Hearing Loss, Sudden

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological 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
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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.

Study Record Dates

• First Submitted: November 10, 2020
• First Posted: November 16, 2020
• Study Start: November 2, 2020
• Primary Completion: May 26, 2021
• Study Completion: September 20, 2021
• Last Updated: February 1, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)