Sensorineural Hearing LossPhase 1/2NCT03616223
FX-322 in Sensorineural Hearing Loss
A Phase 1/2 study testing FX-322 in people with Sensorineural Hearing Loss, run by Frequency Therapeutics at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sensorineural Hearing Loss
- What is being tested?
- FX-322
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jul 2018to 18 Dec 2018
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Sensorineural Hearing Loss
- Being tested
- FX-322, Placebo
- Keywords
- Intratympanic Administration, Hearing Restoration
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FX-322Drug
Intratympanic injection of FX-322 consists of laduviglusib and sodium valproate
PlaceboDrug
Intratympanic injection
| Study group | Role | What they receive |
|---|---|---|
| FX-322 Low Dose | Experimental | Cohort of 8. Single intratympanic injection Receives: Drug: FX-322 |
| FX-322 High Dose | Experimental | Cohort of 8. Single intratympanic injection Receives: Drug: FX-322 |
| Placebo-Low Dose | Placebo comparator | Cohort of 4. Single intratympanic injection Receives: Drug: Placebo |
| Placebo-High Dose | Placebo comparator | Cohort of 4. Single intratympanic injection Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline through Day 90
Secondary outcomes (5)
Cmax
Maximum concentration (Cmax) of FX-322 (Laduviglusib and Sodium Valproate) directly from individual concentration-time data
Measured: Data points taken pre-dose and 0.5, 1, 2, 4, 8, 24 hours post-dose
Tmax
Time to reach maximum concentration of FX-322 (Laduviglusib and Sodium Valproate) directly from individual concentration-time data
Measured: Data points taken pre-dose and 0.5, 1, 2, 4, 8, 24 hours post-dose
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
Measured: Data points taken pre-dose and 0.5, 1, 2, 4, 8, 24 hours post-dose
t1/2
The observed terminal elimination half-life of FX-322 (Laduviglusib and Sodium Valproate)
Measured: Data points taken pre-dose and 0.5, 1, 2, 4, 8, 24 hours post-dose
CL/F
Apparent total body clearance after extravascular administration of FX-322 (Laduviglusib and Sodium Valproate)
Measured: Data points taken pre-dose and 0.5, 1, 2, 4, 8, 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start3 Jul 2018
- Primary completion18 Dec 2018
- Study completion18 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sensorineural Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frequency Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- George Atiee, MD, Principal investigator, Worldwide Clinical Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03616223
- Sponsor's protocol ID
- FX-322-201
- Status last verified
- Oct 2022
- First submitted
- 16 Jul 2018
- Last updated
- 14 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03616223
- Acronym / sponsor ID
- FX-322-201
- Conditions
- Sensorineural Hearing Loss
- Keywords
- Intratympanic Administration, Hearing Restoration
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Frequency TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 3 Jul 2018 (actual)
- Primary completion
- 18 Dec 2018 (actual)
- Study completion
- 18 Dec 2018 (actual)
- First posted
- 6 Aug 2018 (actual)
- Results
- Posted 14 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| FX-322 Low Dose | Experimental | Drug: FX-322Cohort of 8. Single intratympanic injection |
| FX-322 High Dose | Experimental | Drug: FX-322Cohort of 8. Single intratympanic injection |
| Placebo-Low Dose | Placebo comparator | Drug: PlaceboCohort of 4. Single intratympanic injection |
| Placebo-High Dose | Placebo comparator | Drug: PlaceboCohort of 4. Single intratympanic injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FX-322Intratympanic injection of FX-322 consists of laduviglusib and sodium valproate | Drug | FX-322 High Dose, FX-322 Low Dose |
| PlaceboIntratympanic injection | Drug | Placebo-High Dose, Placebo-Low Dose |
Primary outcome
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.
5 secondary outcomes
Cmax
Time frame: 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
AUClast
Time frame: 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
CL/F
Time frame: Data points taken pre-dose and 0.5, 1, 2, 4, 8, 24 hours post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Journal articleLink provided by the sponsor.
Related trials for Sensorineural Hearing Loss
Not yet recruiting
Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
Sensorineural Hearing Loss, Tinnitus
Enrolling by invitationObservational study
Comparing an AI-driven Hearing Test With the Standard Hearing Test in Adults With Hearing Loss and Tinnitus
Sensorineural Hearing Loss, Tinnitus
Active, not recruiting
An Investigation to Evaluate Sound Coding Enhancements in Adult Cochlear Implant Recipients
Cochlear Implant Recipients, Hearing Loss, Cochlear
RecruitingPhase 2
Efficacy and Safety of Hydroxychloroquine in the Treatment of Sudden Sensorineural Hearing Loss
Sudden Hearing Loss
RecruitingObservational study
Cisplatin-induced Cochlear and Vestibular Damage in Head and Neck Cancer
Ototoxic Hearing Loss, Ototoxicity, Drug-Induced
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George Atiee, MD principal investigator
Worldwide Clinical Trials
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing FX-322 in people with Sensorineural Hearing Loss, run by Frequency Therapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-emergent Adverse Event(s) (TEAEs) (time frame: Baseline through Day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022.