Hearing Loss
Conditions
Brief summary
This is a phase 1 safety study performed in male or female adult participants with an established diagnosis of severe to profound sensorineural hearing loss that meets the criteria for cochlear implantation and the participant has already chosen to undergo cochlear implant surgery.
Detailed description
Approximately 12 participants will be enrolled in the study. Assessed will be safety and tolerability of FX-322 administered by intratympanic injection. Also assessed will be the FX-322 concentration in cochlear fluid (perilymph), the pharmacokinetic (PK) profile of FX-322 to determine the systemic exposure to FX-322.
Interventions
DRUGFX-322
intratympanic injection
DRUGPlacebo
intratympanic injection
Sponsors
Frequency Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Male or female adult subjects with an established diagnosis of severe to profound sensorineural hearing loss audiometric threshold of 80 dB HL or poorer at 500 Hz that meets the criteria for cochlear implantation and the subject has already chosen to undergo cochlear implant surgery. 2. Willingness and ability to comply with scheduled visits, ear examination, drug administration plan, auditory and laboratory tests, study restrictions, and all study procedures. Other protocol-defined inclusion criteria may apply
Exclusion criteria
1. Persistent perforation of tympanic membrane or other tympanic membrane disorder that would interfere with the delivery and safety assessment of an intra -tympanic medication or reasonably be suspected to affect tympanic membrane healing after injection. 2. Any conductive component defined as air-bone gaps \>10 dB at two or more frequencies. Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment-emergent adverse events (Safety and Tolerability) of FX-322. | Treatment-emergent adverse events will be assessed over a several hour to two week period | To assess the incidence of adverse safety events (vertigo, tinnitus, perforation) including severe adverse events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Pharmacokinetics | Systemic exposure will be evaluated over a 72 hour period | Drug exposure in the systemic circulation by evaluating Cmax and AUC Drug exposure evaluated by area under the plasma concentration versus time curve (AUC) |
| Cochlear Perilymph Pharmacokinetics | within a 24 hour period after injection | single time point measurement in each patient of drug in cochlear perilymph |
Countries
Australia
Outcome results
None listed