FX-322 in 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: NCT03616223 |
Recruitment Status :
Completed
First Posted : August 6, 2018
Last Update Posted : March 30, 2021
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Condition or disease | Intervention/treatment | Phase |
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Sensorineural Hearing Loss | Drug: FX-322 Drug: Placebo | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 23 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1/2 Randomized, Double-blind, Placebo-controlled, Single-dose Study of FX-322 Administered by Intratympanic Injection in Adults With Stable Sensorineural Hearing Loss |
Actual Study Start Date : | July 3, 2018 |
Actual Primary Completion Date : | December 31, 2018 |
Actual Study Completion Date : | April 1, 2019 |

Arm | Intervention/treatment |
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Experimental: FX-322 Low Dose
Single intratympanic injection of a hydrogel formulation
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Drug: FX-322
Cohort of 8 subjects |
Experimental: FX-322 High Dose
Single intratympanic injection of a hydrogel formulation
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Drug: FX-322
Cohort of 8 subjects |
Placebo Comparator: Placebo
Single intratympanic injection of a hydrogel formulation
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Drug: Placebo
2 Cohorts of 4 subjects each |
- Number of participants with treatment-related adverse events assessed by CTCAE v5.0 [ Time Frame: Day 15 ]
- Time-concentration profile of FX-322 in plasma [ Time Frame: Baseline, Day 1, Day 2 ]Blood samples to be collected within the first 24 hours of dosing to measure drug concentration in the circulation.

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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:
- Adult aged 18-65 years.
- Established diagnosis of stable sensorineural hearing loss (no changes of 10 dB or more at any frequency) by standard audiometric measures for >6 months.
- Documented medical history consistent with hearing loss being caused by noise exposure or sudden sensorineural hearing loss (documented audiogram at least 6 months prior to screening required).
- 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:
- 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 either ear. This includes a current tympanostomy tubes.
- Any conductive hearing loss of 10 dB or more at two or more frequencies in either ear.
- A pure tone average of 70 dB or greater at 500Hz, 1000Hz, 2000Hz, and 4000Hz in the ear to be injected.
- 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 (e.g. rheumatoid arthritis, Sjogren's syndrome, multiple sclerosis, psoriasis).
- History of head or neck radiation treatment or exposure.
- History of substance abuse within 2 years of the Screening Visit.
- 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 such as psychiatric disease or suicidal tendencies.

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): NCT03616223
United States, Texas | |
Worldwide Clinical Trials | |
San Antonio, Texas, United States, 78217 |
Principal Investigator: | George Atiee, MD | Worldwide Clinical Trials |
Responsible Party: | Frequency Therapeutics |
ClinicalTrials.gov Identifier: | NCT03616223 |
Other Study ID Numbers: |
FX-322-201 |
First Posted: | August 6, 2018 Key Record Dates |
Last Update Posted: | March 30, 2021 |
Last Verified: | March 2021 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Intratympanic Administration Hearing Restoration |
Hearing Loss Deafness Hearing Loss, Sensorineural Hearing Disorders Ear Diseases |
Otorhinolaryngologic Diseases Sensation Disorders Neurologic Manifestations Nervous System Diseases |