First in Human Safety Study of FX-345 in Adults With Sensorineural Hearing Loss
NCT ID: NCT05664100
Last Updated: 2023-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
6 participants
INTERVENTIONAL
2022-12-15
2023-04-12
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
TRIPLE
Study Groups
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FX-345 Cohort 1
Patients in the first cohort receiving FX-345 intratympanic injection
FX-345
Single intratympanic injection of FX-345
Placebo Cohort 1
Patients in the first cohort receiving placebo intratympanic injection
Placebo
Single intratympanic injection of placebo
FX-345 Cohort 2
Patients in the second cohort receiving FX-345 intratympanic injection
FX-345
Single intratympanic injection of FX-345
Placebo Cohort 2
Patients in the second cohort receiving placebo intratympanic injection
Placebo
Single intratympanic injection of placebo
Interventions
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FX-345
Single intratympanic injection of FX-345
Placebo
Single intratympanic injection of placebo
Eligibility Criteria
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Inclusion Criteria
* Documented medical history consistent with acquired, adult onset, sensorineural hearing loss
* At the Screening, Lead-in (Visit 2) and Treatment (Day 1) Visits, a pure tone average of 40- 80 dBHL at 500Hz, 1000Hz, 2000Hz, and 4000Hz in the potential study ear to be injected
* Female participants must not be pregnant, breastfeeding, or lactating. Women of child-bearing potential must agree to use a highly effective contraceptive method and must have a negative urine pregnancy test.
* Male participants must refrain from donating sperm and agree to be either abstinent or use a barrier method of contraception
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 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, Lead-in (Visit 2) or Treatment (Day 1) Visits, based on the investigator's judgment.
* Active chronic middle ear disease or a history of major middle ear surgery, as an adult, in the ear to be injected.
* Within 3 months of screening visit any of the following: 1) an intratympanic injection in either ear 2) treatment with steroids 3) onset of sudden sensorineural hearing loss
* Evidence of or previous diagnosis of traumatic brain injury, Meniere's disease, or genetic hearing loss
* History of head or neck radiation, significant systemic autoimmune disease, and/or chronic, recurrent clinically significant vestibular symptoms
* Exposure to another investigational drug within 28 days prior to screening visit
18 Years
67 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
Sarasota, Florida, United States
Clinical Trial Site
Spartanburg, South Carolina, United States
Clinical Trial Site
San Antonio, Texas, United States
Clinical Trial Site
San Antonio, Texas, United States
Countries
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Other Identifiers
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FX-345-101
Identifier Type: -
Identifier Source: org_study_id
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