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FX-322 in Adults With Age-Related 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04601909
Recruitment Status : Active, not recruiting
First Posted : October 26, 2020
Last Update Posted : December 17, 2020
Sponsor:
Information provided by (Responsible Party):
Frequency Therapeutics

Tracking Information
First Submitted Date  ICMJE October 12, 2020
First Posted Date  ICMJE October 26, 2020
Last Update Posted Date December 17, 2020
Actual Study Start Date  ICMJE September 17, 2020
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 20, 2020)
  • 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
  • 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.
  • 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.
  • Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 3 months ]
    Risk assessment through a series of simple, plain-language questions
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2020)
  • 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.
  • 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
  • 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)
  • 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)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE FX-322 in Adults With Age-Related Sensorineural Hearing Loss
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE 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
Condition  ICMJE
  • Presbycusis
  • Hearing Loss, Sensorineural
  • Noise Induced Hearing Loss
  • Sudden Hearing Loss
Intervention  ICMJE
  • Drug: FX-322
    active comparator
  • Other: placebo
    placebo
Study Arms  ICMJE
  • Active Comparator: FX-322
    FX-322, 1 dose (N=24)
    Intervention: Drug: FX-322
  • Placebo Comparator: Placebo
    Placebo, 1 dose (n=6)
    Intervention: Other: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 20, 2020)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 66 Years to 85 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04601909
Other Study ID Numbers  ICMJE FX-322-112
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Frequency Therapeutics
Study Sponsor  ICMJE Frequency Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Carl LeBel, PhD Frequency Therapeutics
PRS Account Frequency Therapeutics
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP