Back to resultsFX-322 in Sensorineural Hearing Loss
Primary Purpose
Sensorineural Hearing Loss
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
FX-322
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Sensorineural Hearing Loss focused on measuring Intratympanic Administration, Hearing Restoration
Eligibility Criteria
Inclusion Criteria:
- Adult aged 18-65 years.
- Established diagnosis of stable sensorineural hearing loss (no changes of 10 dB or more at any frequency) by standard audiometric measures for >6 months.
- 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).
- 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:
- 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.
- Any conductive hearing loss of 10 dB or more at two or more frequencies in either ear.
- A pure tone average of 70 dB or greater at 500Hz, 1000Hz, 2000Hz, and 4000Hz in the ear to be injected.
- Active chronic middle ear disease or a history of major middle ear surgery, as an adult, in the ear to be injected.
- Subject has had an intratympanic injection in either ear within 6 months of the screening visit.
- History of clinically significant vestibular symptoms at the discretion of the investigator.
- History of clinically significant systemic autoimmune disease (e.g. rheumatoid arthritis, Sjogren's syndrome, multiple sclerosis, psoriasis).
- History of head or neck radiation treatment or exposure.
- History of substance abuse within 2 years of the Screening Visit.
- Positive urine pregnancy test or breast-feeding.
- 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.
Sites / Locations
- Worldwide Clinical Trials
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Placebo Comparator
Placebo Comparator
Arm Label
FX-322 Low Dose
FX-322 High Dose
Placebo-Low Dose
Placebo-High Dose
Arm Description
Cohort of 8. Single intratympanic injection
Cohort of 8. Single intratympanic injection
Cohort of 4. Single intratympanic injection
Cohort of 4. Single intratympanic injection
Outcomes
Primary Outcome Measures
Number of Participants With Treatment-emergent Adverse Event(s) (TEAEs)
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
Cmax
Maximum concentration (Cmax) of FX-322 (Laduviglusib and Sodium Valproate) directly from individual concentration-time data
Tmax
Time to reach maximum concentration of FX-322 (Laduviglusib and Sodium Valproate) directly from individual concentration-time data
AUClast
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
t1/2
The observed terminal elimination half-life of FX-322 (Laduviglusib and Sodium Valproate)
CL/F
Apparent total body clearance after extravascular administration of FX-322 (Laduviglusib and Sodium Valproate)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03616223
Brief Title
FX-322 in Sensorineural Hearing Loss
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
July 3, 2018 (Actual)
Primary Completion Date
December 18, 2018 (Actual)
Study Completion Date
December 18, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Frequency Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sensorineural Hearing Loss
Keywords
Intratympanic Administration, Hearing Restoration
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FX-322 Low Dose
Arm Type
Experimental
Arm Description
Cohort of 8. Single intratympanic injection
Arm Title
FX-322 High Dose
Arm Type
Experimental
Arm Description
Cohort of 8. Single intratympanic injection
Arm Title
Placebo-Low Dose
Arm Type
Placebo Comparator
Arm Description
Cohort of 4. Single intratympanic injection
Arm Title
Placebo-High Dose
Arm Type
Placebo Comparator
Arm Description
Cohort of 4. Single intratympanic injection
Intervention Type
Drug
Intervention Name(s)
FX-322
Intervention Description
Intratympanic injection of FX-322 consists of laduviglusib and sodium valproate
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Intratympanic injection
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-emergent Adverse Event(s) (TEAEs)
Description
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.
Time Frame
Baseline through Day 90
Secondary Outcome Measure Information:
Title
Cmax
Description
Maximum concentration (Cmax) of FX-322 (Laduviglusib and Sodium Valproate) directly from individual concentration-time data
Time Frame
Data points taken pre-dose and 0.5, 1, 2, 4, 8, 24 hours post-dose
Title
Tmax
Description
Time to reach maximum concentration of FX-322 (Laduviglusib and Sodium Valproate) directly from individual concentration-time data
Time Frame
Data points taken pre-dose and 0.5, 1, 2, 4, 8, 24 hours post-dose
Title
AUClast
Description
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
Time Frame
Data points taken pre-dose and 0.5, 1, 2, 4, 8, 24 hours post-dose
Title
t1/2
Description
The observed terminal elimination half-life of FX-322 (Laduviglusib and Sodium Valproate)
Time Frame
Data points taken pre-dose and 0.5, 1, 2, 4, 8, 24 hours post-dose
Title
CL/F
Description
Apparent total body clearance after extravascular administration of FX-322 (Laduviglusib and Sodium Valproate)
Time Frame
Data points taken pre-dose and 0.5, 1, 2, 4, 8, 24 hours post-dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult aged 18-65 years.
Established diagnosis of stable sensorineural hearing loss (no changes of 10 dB or more at any frequency) by standard audiometric measures for >6 months.
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).
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:
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.
Any conductive hearing loss of 10 dB or more at two or more frequencies in either ear.
A pure tone average of 70 dB or greater at 500Hz, 1000Hz, 2000Hz, and 4000Hz in the ear to be injected.
Active chronic middle ear disease or a history of major middle ear surgery, as an adult, in the ear to be injected.
Subject has had an intratympanic injection in either ear within 6 months of the screening visit.
History of clinically significant vestibular symptoms at the discretion of the investigator.
History of clinically significant systemic autoimmune disease (e.g. rheumatoid arthritis, Sjogren's syndrome, multiple sclerosis, psoriasis).
History of head or neck radiation treatment or exposure.
History of substance abuse within 2 years of the Screening Visit.
Positive urine pregnancy test or breast-feeding.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Atiee, MD
Organizational Affiliation
Worldwide Clinical Trials
Official's Role
Principal Investigator
Facility Information:
Facility Name
Worldwide Clinical Trials
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
12. IPD Sharing Statement
Links:
URL
https://journals.lww.com/otology-neurotology/Fulltext/2021/08000/Improved_Speech_Intelligibility_in_Subjects_With.14.aspx
Description
Journal article
Learn more about this trial
FX-322 in Sensorineural Hearing Loss
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