FX-322 in Adults With Age-Related Sensorineural Hearing Loss (NCT04601909) | Clinical Trial Compass
CompletedPhase 1
FX-322 in Adults With Age-Related Sensorineural Hearing Loss
United States30 participantsStarted 2020-09-17
Plain-language summary
This is a Phase 1b, prospective, randomized, double-blind, placebo-controlled, single-dose, multicenter, safety study of FX-322, administered by intratympanic injection, in adults with age-related sensorineural hearing loss.
Who can participate
Age range66 Years – 85 Years
SexALL
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Inclusion criteria
✓. Subject has read and voluntarily signed the Informed Consent Form (ICF) after all questions have been answered and prior to any study-mandated procedure.
✓. Adult aged 66-85 years inclusive.
✓. Documented medical history consistent with age-related sensorineural hearing loss (documented audiogram at least 6 months prior to screening required).
✓. A pure tone average of 26-70 dB at 500Hz, 1000Hz, 2000Hz, and 4000Hz at Screening in the ear to be injected.
✓. Ability to communicate well with the Investigator and is willing to comply with and complete all the study procedures.
Exclusion criteria
✕. Subject has previously participated in a FX-322 clinical trial.
✕. Any subject with a flat audiogram between 500Hz and 8000Hz at Screening in the study ear. The difference in the range of threshold values across frequencies is ≤15 dB for the definition of a flat audiogram.
✕. Clinically significant abnormalities on safety laboratory tests.
✕. 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).
What they're measuring
1
Systemic Safety: Number of patients with treatment-related adverse events
Timeframe: 3 months
2
Local Safety: Number of patients with abnormal changes from baseline in otoscopic examinations
Timeframe: 3 months
3
Local Safety: The number of patients with abnormal changes from baseline in tympanometry
✕. 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 3 months of the screening visit.
✕. History of clinically significant vestibular symptoms at the discretion of the investigator. For example, BPPV may be considered acceptable whereas Meniere's would not.