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FX-322 in Sensorineural Hearing Loss

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ClinicalTrials.gov Identifier: NCT03616223
Recruitment Status : Completed
First Posted : August 6, 2018
Results First Posted : November 14, 2022
Last Update Posted : November 14, 2022
Sponsor:
Information provided by (Responsible Party):
Frequency Therapeutics

Study Description
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Brief Summary:
This is a phase 1/2 study of FX-322 at two dose levels compared to placebo in male and female adults otherwise healthy with stable sensorineural hearing loss.

Condition or disease Intervention/treatment Phase
Sensorineural Hearing Loss Drug: FX-322 Drug: Placebo Phase 1 Phase 2

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 (laduviglusib and sodium valproate) 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Randomized, Double-blind, Placebo-controlled Single Dose Study at Two Dose Levels of FX-322 Administered by Intratympanic Injection in Adults With Stable Sensorineural Hearing Loss
Actual Study Start Date : July 3, 2018
Actual Primary Completion Date : December 18, 2018
Actual Study Completion Date : December 18, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: FX-322 Low Dose
Cohort of 8. Single intratympanic injection
 Drug: FX-322
Intratympanic injection of FX-322 consists of laduviglusib and sodium valproate
Experimental: FX-322 High Dose
Cohort of 8. Single intratympanic injection
 Drug: FX-322
Intratympanic injection of FX-322 consists of laduviglusib and sodium valproate
Placebo Comparator: Placebo-Low Dose
Cohort of 4. Single intratympanic injection
 Drug: Placebo
Intratympanic injection
Placebo Comparator: Placebo-High Dose
Cohort of 4. Single intratympanic injection
 Drug: Placebo
Intratympanic injection


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Treatment-emergent Adverse Event(s) (TEAEs) [ Time Frame: Baseline through Day 90 ]
    Treatment-emergent adverse events (TEAE) were defined as any untoward medical occurrence in a subject administered study drug that does not necessarily have a causal relationship with the treatment and were collected from the time of first dose through end of study (day 90). In particular, audiometric and otoscopic TEAEs were recorded per the American Speech-Language-Hearing Association (ASHA) guidelines.


Secondary Outcome Measures :
  1. Cmax [ Time Frame: Data points taken pre-dose and 0.5, 1, 2, 4, 8, 24 hours post-dose ]
    Maximum concentration (Cmax) of FX-322 (Laduviglusib and Sodium Valproate) directly from individual concentration-time data

  2. Tmax [ Time Frame: Data points taken pre-dose and 0.5, 1, 2, 4, 8, 24 hours post-dose ]
    Time to reach maximum concentration of FX-322 (Laduviglusib and Sodium Valproate) directly from individual concentration-time data

  3. AUClast [ Time Frame: Data points taken pre-dose and 0.5, 1, 2, 4, 8, 24 hours post-dose ]
    Area under the concentration-time curve of FX-322 (Laduviglusib and Sodium Valproate) from time zero to the time of the last quantifiable concentration, calculated using the linear trapezoidal rule

  4. t1/2 [ Time Frame: Data points taken pre-dose and 0.5, 1, 2, 4, 8, 24 hours post-dose ]
    The observed terminal elimination half-life of FX-322 (Laduviglusib and Sodium Valproate)

  5. CL/F [ Time Frame: Data points taken pre-dose and 0.5, 1, 2, 4, 8, 24 hours post-dose ]
    Apparent total body clearance after extravascular administration of FX-322 (Laduviglusib and Sodium Valproate)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03616223


Locations
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United States, Texas
Worldwide Clinical Trials
San Antonio, Texas, United States, 78217
Sponsors and Collaborators
Frequency Therapeutics
Investigators
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Principal Investigator: George Atiee, MD Worldwide Clinical Trials
  Study Documents (Full-Text)

Documents provided by Frequency Therapeutics:
Study Protocol  [PDF] August 2, 2018
Statistical Analysis Plan  [PDF] August 10, 2018

More Information
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Additional Information:

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Responsible Party: Frequency Therapeutics
ClinicalTrials.gov Identifier: NCT03616223    
Other Study ID Numbers: FX-322-201
First Posted: August 6, 2018    Key Record Dates
Results First Posted: November 14, 2022
Last Update Posted: November 14, 2022
Last Verified: October 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Frequency Therapeutics:
Intratympanic Administration
Hearing Restoration
Additional relevant MeSH terms:
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Hearing Loss
Deafness
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
 Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases