Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
23 participants
INTERVENTIONAL
2018-07-03
2018-12-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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FX-322 Low Dose
Cohort of 8. Single intratympanic injection
FX-322
Intratympanic injection of FX-322 consists of laduviglusib and sodium valproate
FX-322 High Dose
Cohort of 8. Single intratympanic injection
FX-322
Intratympanic injection of FX-322 consists of laduviglusib and sodium valproate
Placebo-Low Dose
Cohort of 4. Single intratympanic injection
Placebo
Intratympanic injection
Placebo-High Dose
Cohort of 4. Single intratympanic injection
Placebo
Intratympanic injection
Interventions
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FX-322
Intratympanic injection of FX-322 consists of laduviglusib and sodium valproate
Placebo
Intratympanic injection
Eligibility Criteria
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Inclusion Criteria
2. Established diagnosis of stable sensorineural hearing loss (no changes of 10 dB or more at any frequency) by standard audiometric measures for \>6 months.
3. 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).
4. 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
2. Any conductive hearing loss of 10 dB or more at two or more frequencies in either ear.
3. A pure tone average of 70 dB or greater at 500Hz, 1000Hz, 2000Hz, and 4000Hz in the ear to be injected.
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 6 months of the screening visit.
6. History of clinically significant vestibular symptoms at the discretion of the investigator.
7. History of clinically significant systemic autoimmune disease (e.g. rheumatoid arthritis, Sjogren's syndrome, multiple sclerosis, psoriasis).
8. History of head or neck radiation treatment or exposure.
9. History of substance abuse within 2 years of the Screening Visit.
10. Positive urine pregnancy test or breast-feeding.
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 such as psychiatric disease or suicidal tendencies.
18 Years
65 Years
ALL
No
Sponsors
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Frequency Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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George Atiee, MD
Role: PRINCIPAL_INVESTIGATOR
Worldwide Clinical Trials
Locations
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Worldwide Clinical Trials
San Antonio, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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FX-322-201
Identifier Type: -
Identifier Source: org_study_id
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