FX-322 in Adults With Stable Sensorineural Hearing Loss
NCT ID: NCT04120116
Last Updated: 2023-04-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
95 participants
INTERVENTIONAL
2019-10-04
2020-12-17
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 Single Dose, Placebo Three Doses
Four intratympanic injections of a hydrogel formulation, FX-322 Single Dose, Placebo Three Doses.
FX-322 (One Dose)
Patients will receive one dose of FX-322.
Placebo
Patients will receive Placebo.
FX-322 Two Doses, Placebo Two Doses
Four intratympanic injections of a hydrogel formulation, FX-322 Two Doses, Placebo Two Doses.
FX-322 (Two Doses)
Patients will receive two doses of FX-322.
Placebo
Patients will receive Placebo.
FX-322 Four Doses
Four intratympanic injections of a hydrogel formulation, FX-322 Four Doses.
FX-322 (Four Doses)
Patients will receive four doses of FX-322.
Placebo Four Doses
Four intratympanic injections of a hydrogel formulation, Placebo Four Doses.
Placebo
Patients will receive Placebo.
Interventions
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FX-322 (One Dose)
Patients will receive one dose of FX-322.
FX-322 (Two Doses)
Patients will receive two doses of FX-322.
FX-322 (Four Doses)
Patients will receive four doses of FX-322.
Placebo
Patients will receive Placebo.
Eligibility Criteria
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Inclusion Criteria
2. 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).
3. Documented medical history consistent with hearing loss being caused by noise exposure or sudden sensorineural hearing loss.
4. Pure Tone Audiometry (PTA) within 26-70 dB in the ear to be injected.
5. 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. Currently on any medication consisting of valproic acid, valproate sodium, or divalproex sodium.
3. 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.
4. 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).
5. Active chronic middle ear disease or a history of major middle ear surgery, as an adult, in the ear to be injected.
6. Subject has had an intratympanic injection in either ear within 6 months of the screening visit.
7. History of clinically significant vestibular symptoms at the discretion of the investigator.
8. History of clinically significant systemic autoimmune disease.
9. History of head or neck radiation treatment or exposure.
10. History of platinum-based chemotherapy treatment.
11. Exposure to another investigational drug within 28 days prior to injection of study drug.
12. 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).
13. History of substance abuse within 2 years of the Screening Visit.
14. Positive test for drugs of abuse at screening.
15. Positive urine pregnancy test or breast-feeding.
16. 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).
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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Carl LeBel, PhD
Role: STUDY_DIRECTOR
Frequency Therapeutics
Locations
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Clinical Trial Site
Fresno, California, United States
Clinical Trial Site
Torrance, California, United States
Clinical Trial Site
Colorado Springs, Colorado, United States
Clinical Trial Site
Boca Raton, Florida, United States
Clinical Trial Site
Sarasota, Florida, United States
Clinical Trial Site
Tampa, Florida, United States
Clinical Trial Site
Louisville, Kentucky, United States
Clinical Trial Site
Omaha, Nebraska, United States
Clinical Trial Site
Amherst, New York, United States
Clinical Trial Site
Matthews, North Carolina, United States
Clinical Trial Site
Winston-Salem, North Carolina, United States
Clinical Trial Site
Orangeburg, South Carolina, United States
Clinical Trial Site
Austin, Texas, United States
Clinical Trial Site
San Antonio, Texas, United States
Clinical Trial Site
San Antonio, Texas, United States
Clinical Trial Site
Richmond, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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FX-322-202
Identifier Type: -
Identifier Source: org_study_id
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