FX-322 in Adults With Stable Sensorineural Hearing Loss

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Brief Title

FX-322 in Adults With Stable Sensorineural Hearing Loss

Official Title

A Phase 2a, Prospective, Randomized, Double-Blind, Placebo-Controlled, Single and Repeat-Dose, Multicenter, Exploratory Efficacy Study of FX-322 Administered by Intratympanic Injection in Adults With Stable Sensorineural Hearing Loss

Brief Summary

      This is a phase 2a single and repeat dose exploratory efficacy study of intratympanic FX-322
      compared to placebo in healthy male and female adults with stable sensorineural hearing loss.
    

Detailed Description

      Sensorineural hearing loss (SNHL) accounts for about 90% of all cases of hearing loss. This
      phase 2a study will assess the exploratory efficacy, as well as the local and systemic safety
      of single and repeat intratympanic doses of FX-322 compared to placebo in approximately 96
      subjects with stable mild to moderately severe sensorineural hearing loss, with a medical
      history consistent with either excessive noise exposure or idiopathic sudden sensorineural
      hearing loss.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Speech Intelligibility

Secondary Outcome

 Extended High Frequency Pure Tone Audiometry

Condition

Sensorineural Hearing Loss

Intervention

FX-322

Study Arms / Comparison Groups

 FX-322 Single Dose, Placebo Three Doses
Description:  Four intratympanic injections 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

95

Start Date

October 4, 2019

Completion Date

May 21, 2021

Primary Completion Date

October 6, 2020

Eligibility Criteria

        Inclusion Criteria:

          1. Adults aged 18-65 years inclusive.

          2. Established diagnosis of stable sensorineural hearing loss by standard audiometric
             measures for ≥ 6 months prior to the Screening visit (no changes in air conduction
             greater than 10 dB at a single frequency or greater than 5 dB at two contiguous
             frequencies from the prior audiogram to the Screening audiogram in the study ear).

          3. Documented medical history consistent with hearing loss being caused by noise exposure
             or sudden sensorineural hearing loss.

          4. Pure Tone Audiometry (PTA) within 26-70 dB in the ear to be injected.

          5. 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. Previous participation in FX-322 clinical trial.

          2. Currently on any medication consisting of valproic acid, valproate sodium, or
             divalproex sodium.

          3. 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.

          4. 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).

          5. Active chronic middle ear disease or a history of major middle ear surgery, as an
             adult, in the ear to be injected.

          6. Subject has had an intratympanic injection in either ear within 6 months of the
             screening visit.

          7. History of clinically significant vestibular symptoms at the discretion of the
             investigator.

          8. History of clinically significant systemic autoimmune disease.

          9. History of head or neck radiation treatment or exposure.

         10. History of platinum-based chemotherapy treatment.

         11. Exposure to another investigational drug within 28 days prior to injection of study
             drug.

         12. Evidence of any active or chronic disease or condition that could interfere with, or
             for which the treatment of might interfere with, the conduct of the study, or that
             would pose an unacceptable risk to the subject in the opinion of the investigator
             following a detailed medical history, physical examination, and vital signs (systolic
             and diastolic blood pressure, pulse rate, body temperature).

         13. History of substance abuse within 2 years of the Screening Visit.

         14. Positive test for drugs of abuse at screening.

         15. Positive urine pregnancy test or breast-feeding.

         16. 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
             (e.g. previous high-dose aminoglycoside treatment).
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Carl LeBel, PhD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04120116

Organization ID

FX-322-202


Responsible Party

Sponsor

Study Sponsor

Frequency Therapeutics


Study Sponsor

Carl LeBel, PhD, Study Director, Frequency Therapeutics


Verification Date

October 2020