Brief Title
FX-322 in Sensorineural Hearing Loss
Official Title
A Phase 1/2 Randomized, Double-blind, Placebo-controlled, Single-dose Study of FX-322 Administered by Intratympanic Injection in Adults With Stable Sensorineural Hearing Loss
Brief Summary
This is a phase 1/2 single dose study of FX-322 compared to placebo in male and female adults otherwise healthy with stable sensorineural hearing loss.
Detailed Description
Sensorineural hearing loss (SNHL) accounts for about 90% of all cases of hearing loss. The study will assess the safety of FX-322 given as a single intratympanic injection in subjects with a medical history of sensorineural hearing loss that is associated with noise exposure or sudden hearing loss. Safety will be evaluated both systemically (lab and clinical monitoring) and locally (otoscopy and audiometry) in 24 subjects, and a blood PK profile of FX-322 will also be determined.
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
Number of participants with treatment-related adverse events assessed by CTCAE v5.0
Secondary Outcome
Time-concentration profile of FX-322 in plasma
Condition
Sensorineural Hearing Loss
Intervention
FX-322
Study Arms / Comparison Groups
FX-322 Low Dose
Description: Single intratympanic injection of a hydrogel formulation
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
23
Start Date
July 3, 2018
Completion Date
April 1, 2019
Primary Completion Date
December 31, 2018
Eligibility Criteria
Inclusion Criteria: 1. Adult aged 18-65 years. 2. Established diagnosis of stable sensorineural hearing loss (no changes of 10 dB or more at any frequency) by standard audiometric measures for >6 months. 3. Documented medical history consistent with hearing loss being caused by noise exposure or sudden sensorineural hearing loss (documented audiogram at least 6 months prior to screening required). 4. 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: 1. 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 either ear. This includes a current tympanostomy tubes. 2. Any conductive hearing loss of 10 dB or more at two or more frequencies in either ear. 3. A pure tone average of 70 dB or greater at 500Hz, 1000Hz, 2000Hz, and 4000Hz in the ear to be injected. 4. Active chronic middle ear disease or a history of major middle ear surgery, as an adult, in the ear to be injected. 5. Subject has had an intratympanic injection in either ear within 6 months of the screening visit. 6. History of clinically significant vestibular symptoms at the discretion of the investigator. 7. History of clinically significant systemic autoimmune disease (e.g. rheumatoid arthritis, Sjogren's syndrome, multiple sclerosis, psoriasis). 8. History of head or neck radiation treatment or exposure. 9. History of substance abuse within 2 years of the Screening Visit. 10. Positive urine pregnancy test or breast-feeding. 11. 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 such as psychiatric disease or suicidal tendencies.
Gender
All
Ages
18 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
George Atiee, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03616223
Organization ID
FX-322-201
Responsible Party
Sponsor
Study Sponsor
Frequency Therapeutics
Study Sponsor
George Atiee, MD, Principal Investigator, Worldwide Clinical Trials
Verification Date
September 2020