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FX-322 in Adults With Severe Sensorineural Hearing Loss

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04629664
Recruitment Status : Recruiting
First Posted : November 16, 2020
Last Update Posted : November 19, 2020
Sponsor:
Information provided by (Responsible Party):
Frequency Therapeutics

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.

Condition or disease Intervention/treatment Phase
Hearing Loss, Sensorineural Noise Induced Hearing Loss Sudden Hearing Loss Drug: FX-322 Other: Placebo Phase 1

Detailed Description:

This is a Phase 1b placebo-controlled, double-blind, single-dose safety study of intratympanic FX-322 dosed in subjects with severe 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-Blind
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 2, 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: FX-322
FX-322, 1 dose (N=24)
Drug: FX-322
Active Comparator

Placebo Comparator: Placebo
Placebo, 1 dose (n=6)
Other: Placebo
Placebo




Primary Outcome Measures :
  1. 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

  2. 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. 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.

  4. Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 3 months ]
    Risk assessment through a series of simple, plain-language questions


Secondary Outcome Measures :
  1. 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.

  2. Audiologic Response: Speech Intelligibility - Bamford-Kowal-Bench Speech in Noise (BKB-SIN) [ Time Frame: 3 months ]
    Speech intelligibility using the BKB-SIN test measured with a list of sentences presented to the subject.

  3. 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)

  4. 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)

  5. Tinnitus Assessment [ Time Frame: 2 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 18-65 years inclusive.
  3. Documented medical history consistent with severe sensorineural hearing loss (documented audiogram at least 6 months prior to screening required).
  4. A pure tone average of 71-90 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. 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.
  3. 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).
  4. Active chronic middle ear disease or a history of major middle ear surgery, as an adult, in the ear to be injected.
  5. Subject has had an intratympanic injection in either ear within 3 months of the screening visit.
  6. History of clinically significant vestibular symptoms at the discretion of the investigator. For example, BPPV may be considered acceptable whereas Meniere's would not.
  7. History of clinically significant systemic autoimmune disease (e.g. rheumatoid arthritis, Sjogren's syndrome, multiple sclerosis, psoriasis).
  8. Exposure to another investigational drug within 28 days prior to injection of study drug.
  9. 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).
  10. 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.

  11. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04629664


Contacts
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Contact: Clinical Trials Information Desk 800-839-9241 ClinicalTrialsInformation@FrequencyTx.com

Locations
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United States, Michigan
Clinical Trial Site Recruiting
Novi, Michigan, United States, 00000
United States, New York
Clinical Trial Site Recruiting
Amherst, New York, United States, 00000
United States, South Carolina
Clinical Trial Site Recruiting
Orangeburg, South Carolina, United States, 00000
United States, Texas
Clinical Trial Site Recruiting
San Antonio, Texas, United States, 00000
United States, Virginia
Clinical Trial Site Recruiting
Norfolk, Virginia, United States, 00000
Sponsors and Collaborators
Frequency Therapeutics
Investigators
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Study Director: Carl LeBel, PhD Frequency Therapeutics
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Responsible Party: Frequency Therapeutics
ClinicalTrials.gov Identifier: NCT04629664    
Other Study ID Numbers: FX-322-113
First Posted: November 16, 2020    Key Record Dates
Last Update Posted: November 19, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Frequency Therapeutics:
Intratympanic administration
Restoration of hearing loss
Additional relevant MeSH terms:
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Hearing Loss
Deafness
Hearing Loss, Sensorineural
Hearing Loss, Noise-Induced
Hearing Loss, Sudden
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases