Status:
COMPLETED
First in Human Safety Study of FX-322 in Adults Undergoing Cochlear Implantation
Lead Sponsor:
Frequency Therapeutics
Conditions:
Hearing Loss
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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 implan...
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 ...
Eligibility Criteria
Inclusion
- 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.
- 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
- 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.
- Any conductive component defined as air-bone gaps \>10 dB at two or more frequencies.
- Other protocol-defined exclusion criteria may apply
Key Trial Info
Start Date :
May 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 18 2018
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT03300687
Start Date
May 30 2017
End Date
January 18 2018
Last Update
April 12 2018
Active Locations (1)
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1
Royal Victoria Eye and Ear Hospital
Melbourne, Victoria, Australia