FX-322 in Sensorineural Hearing Loss

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 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

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

April 2019