Completed
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
What is being tested
FX-322
+ Placebo
Drug
Who is being recruted
Ear Diseases+7
+ Hearing Disorders
+ Hearing Loss, Sensorineural
From 18 to 65 Years
+15 Eligibility Criteria
How is the trial designed
Treatment Study
Placebo-ControlledPhase 1 & 2
Interventional
Study Start: July 2018
Summary
Principal SponsorFrequency Therapeutics
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: July 3, 2018
Actual date on which the first participant was enrolled.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.
Official TitleA 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
Principal SponsorFrequency Therapeutics
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
23 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Ear DiseasesHearing DisordersHearing Loss, SensorineuralNervous System DiseasesNeurologic ManifestationsOtorhinolaryngologic DiseasesSensation DisordersSigns and SymptomsPathological Conditions, Signs and SymptomsHearing Loss
Criteria
4 inclusion criteria required to participate
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.
11 exclusion criteria prevent from participating
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.
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
4 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalCohort of 8. Single intratympanic injection
Group II
ExperimentalCohort of 8. Single intratympanic injection
Group III
PlaceboCohort of 4. Single intratympanic injection
Group IV
PlaceboCohort of 4. Single intratympanic injection
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Suspended
CompletedOne Study Center