FX-322 in Adults With Stable Sensorineural Hearing Loss
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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: NCT04120116 |
Recruitment Status :
Completed
First Posted : October 9, 2019
Last Update Posted : October 31, 2022
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Condition or disease | Intervention/treatment | Phase |
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Sensorineural Hearing Loss Noise Induced Hearing Loss Sudden Sensorineural Hearing Loss | Drug: FX-322 (One Dose) Drug: FX-322 (Two Doses) Drug: FX-322 (Four Doses) Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 95 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2a, Prospective, Randomized, Double-Blind, Placebo-Controlled, Single and Repeat-Dose, Multicenter, Exploratory Efficacy Study of FX-322 Administered by Intratympanic Injection in Adults With Stable Sensorineural Hearing Loss |
Actual Study Start Date : | October 4, 2019 |
Actual Primary Completion Date : | October 6, 2020 |
Actual Study Completion Date : | December 17, 2020 |

Arm | Intervention/treatment |
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Experimental: FX-322 Single Dose, Placebo Three Doses
Four intratympanic injections of a hydrogel formulation, FX-322 Single Dose, Placebo Three Doses.
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Drug: FX-322 (One Dose)
Patients will receive one dose of FX-322. Drug: Placebo Patients will receive Placebo. |
Experimental: FX-322 Two Doses, Placebo Two Doses
Four intratympanic injections of a hydrogel formulation, FX-322 Two Doses, Placebo Two Doses.
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Drug: FX-322 (Two Doses)
Patients will receive two doses of FX-322. Drug: Placebo Patients will receive Placebo. |
Experimental: FX-322 Four Doses
Four intratympanic injections of a hydrogel formulation, FX-322 Four Doses.
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Drug: FX-322 (Four Doses)
Patients will receive four doses of FX-322. |
Placebo Comparator: Placebo Four Doses
Four intratympanic injections of a hydrogel formulation, Placebo Four Doses.
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Drug: Placebo
Patients will receive Placebo. |
- Speech Intelligibility - Word Recognition in Quiet [ Time Frame: Screening to Day 210 ]Assessment of speech intelligibility using the Word Recognition in Quiet test measured with Consonant-Nucleus-Consonant (CNC) word lists.
- Speech Intelligibility - Words-in-Noise [ Time Frame: Screening to Day 210 ]Speech intelligibility using the Words-in-Noise test measured with Consonant-Nucleus-Consonant (CNC) word lists
- Standard Pure Tone Audiometry [ Time Frame: Screening to Day 210 ]Standard pure tone audiometry will be measured to determine a subject's threshold for hearing at standard frequencies (Hz)
- Systemic Safety: Number of patients with treatment-related adverse events [ Time Frame: Screening to Day 210 ]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: Screening to Day 210 ]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: Screening to Day 210 ]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.
- Extended High Frequency Pure Tone Audiometry [ Time Frame: Screening to Day 210 ]Pure tone audiometry will be measured to determine a subject's threshold for hearing at extended high range frequencies (Hz)
- Tinnitus Assessment [ Time Frame: Screening to Day 210 ]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.
- Hearing Handicap Inventory [ Time Frame: Screening to Day 210 ]The Hearing Handicap Inventory for Adults (HHIA), is a 25-item self-assessment scale composed of two subscales (emotional and social/situational). The subject will self-report one of the following answers for each item on the scale: Yes, Sometimes, No.
- Hearing Screening Inventory [ Time Frame: Screening to Day 210 ]The Hearing Screening Inventory (HSI) is a 12 item self report inventory to assess hearing impairment. The subject will self report one of the following answers, for each question from 1 to 8: Never, Seldom, Occasionally, Frequently, Always, and for each question from 9 to 12: Good, Average, Slightly below average, Poor, Very Poor. The HSI is designed to assess subjective change during the study.

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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 |
Inclusion Criteria:
- Adults aged 18-65 years inclusive.
- Established diagnosis of stable sensorineural hearing loss by standard audiometric measures for ≥ 6 months prior to the Screening visit (no changes in air conduction greater than 10 dB at a single frequency or greater than 5 dB at two contiguous frequencies from the prior audiogram to the Screening audiogram in the study ear).
- Documented medical history consistent with hearing loss being caused by noise exposure or sudden sensorineural hearing loss.
- Pure Tone Audiometry (PTA) within 26-70 dB in the ear to be injected.
- Female subjects must be of non-childbearing potential or will need to utilize two methods of highly effective contraception during the study participation (e.g. hormonal contraception or an intrauterine device and condoms) or remain abstinent. Male subjects should use condoms with spermicide during the course of the study or remain abstinent. Subjects should not donate sperm or ova during the study period.
Exclusion Criteria:
- Previous participation in FX-322 clinical trial.
- Currently on any medication consisting of valproic acid, valproate sodium, or divalproex sodium.
- 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 6 months of the screening visit.
- History of clinically significant vestibular symptoms at the discretion of the investigator.
- History of clinically significant systemic autoimmune disease.
- History of head or neck radiation treatment or exposure.
- History of platinum-based chemotherapy treatment.
- 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).
- History of substance abuse within 2 years of the Screening Visit.
- Positive test for drugs of abuse at screening.
- Positive urine pregnancy test or breast-feeding.
- 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).

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): NCT04120116
United States, California | |
Clinical Trial Site | |
Fresno, California, United States, 93720 | |
Clinical Trial Site | |
Torrance, California, United States, 90503 | |
United States, Colorado | |
Clinical Trial Site | |
Colorado Springs, Colorado, United States, 80909 | |
United States, Florida | |
Clinical Trial Site | |
Boca Raton, Florida, United States, 33487 | |
Clinical Trial Site | |
Sarasota, Florida, United States, 34239 | |
Clinical Trial Site | |
Tampa, Florida, United States, 33612 | |
United States, Kentucky | |
Clinical Trial Site | |
Louisville, Kentucky, United States, 40207 | |
United States, Nebraska | |
Clinical Trial Site | |
Omaha, Nebraska, United States, 68118 | |
United States, New York | |
Clinical Trial Site | |
Amherst, New York, United States, 14226 | |
United States, North Carolina | |
Clinical Trial Site | |
Matthews, North Carolina, United States, 28105 | |
Clinical Trial Site | |
Winston-Salem, North Carolina, United States, 27103 | |
United States, South Carolina | |
Clinical Trial Site | |
Orangeburg, South Carolina, United States, 29118 | |
United States, Texas | |
Clinical Trial Site | |
Austin, Texas, United States, 78705 | |
Clinical Trial Site | |
San Antonio, Texas, United States, 78240 | |
Clinical Trial Site | |
San Antonio, Texas, United States, 78258 | |
United States, Virginia | |
Clinical Trial Site | |
Richmond, Virginia, United States, 23235 |
Study Director: | Carl LeBel, PhD | Frequency Therapeutics |
Responsible Party: | Frequency Therapeutics |
ClinicalTrials.gov Identifier: | NCT04120116 |
Other Study ID Numbers: |
FX-322-202 |
First Posted: | October 9, 2019 Key Record Dates |
Last Update Posted: | October 31, 2022 |
Last Verified: | October 2022 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Intratympanic Administration Restoration of Hearing Function |
Hearing Loss Deafness Hearing Loss, Sensorineural Hearing Loss, Noise-Induced Hearing Disorders |
Ear Diseases Otorhinolaryngologic Diseases Sensation Disorders Neurologic Manifestations Nervous System Diseases |