- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03616223
FX-322 in Sensorineural Hearing Loss
October 19, 2022 updated by: Frequency Therapeutics
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
23
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
San Antonio, Texas, United States, 78217
- Worldwide Clinical Trials
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: FX-322 Low Dose
Cohort of 8. Single intratympanic injection
|
Intratympanic injection of FX-322 consists of laduviglusib and sodium valproate
|
Experimental: FX-322 High Dose
Cohort of 8. Single intratympanic injection
|
Intratympanic injection of FX-322 consists of laduviglusib and sodium valproate
|
Placebo Comparator: Placebo-Low Dose
Cohort of 4. Single intratympanic injection
|
Intratympanic injection
|
Placebo Comparator: Placebo-High Dose
Cohort of 4. Single intratympanic injection
|
Intratympanic injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline through Day 90
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Data points taken pre-dose and 0.5, 1, 2, 4, 8, 24 hours post-dose
|
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
|
Data points taken pre-dose and 0.5, 1, 2, 4, 8, 24 hours post-dose
|
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
|
Data points taken pre-dose and 0.5, 1, 2, 4, 8, 24 hours post-dose
|
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)
|
Data points taken pre-dose and 0.5, 1, 2, 4, 8, 24 hours post-dose
|
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)
|
Data points taken pre-dose and 0.5, 1, 2, 4, 8, 24 hours post-dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: George Atiee, MD, Worldwide Clinical Trials
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 3, 2018
Primary Completion (Actual)
December 18, 2018
Study Completion (Actual)
December 18, 2018
Study Registration Dates
First Submitted
July 16, 2018
First Submitted That Met QC Criteria
July 31, 2018
First Posted (Actual)
August 6, 2018
Study Record Updates
Last Update Posted (Actual)
November 14, 2022
Last Update Submitted That Met QC Criteria
October 19, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FX-322-201
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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