Hearing Loss, SensorineuralPhase 1NCT04629664
FX-322 in Adults With Severe Sensorineural Hearing Loss
A Phase 1 study testing FX-322 in people with Hearing Loss, Sensorineural and Noise Induced Hearing Loss, run by Frequency Therapeutics at 7 sites in United States.
Trial summary
This is a Phase 1b, prospective, randomized, double-blind, placebo-controlled, single-dose, multicenter, safety study of FX-322, administered by intratympanic injection, in adults with severe sensorineural hearing loss. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hearing Loss, Sensorineural, Noise Induced Hearing Loss, Sudden Hearing Loss
- What is being tested?
- FX-322
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 7 sitesUnited States
- Study dates
- 2 Nov 2020to 20 Sep 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Subject has read and voluntarily signed the Informed Consent Form (ICF) after all questions have been answered and prior to any study-mandated procedure.
- Adult aged 18-65 years inclusive.
- Documented medical history consistent with acquired (non-genetic) severe sensorineural hearing loss (documented audiogram at least 6 months prior to screening required).
- A pure tone average of 71-90 dB at 500Hz, 1000Hz, 2000Hz, and 4000Hz at Screening in the ear to be injected.
- Ability to communicate well with the Investigator and is willing to comply with and complete all the study procedures.
Who cannot join
- Subject has previously participated in a FX-322 clinical trial.
- 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 study ear. This includes a current tympanostomy tube.
- Any conductive hearing loss of greater than 15 dB at a single frequency or greater than 10 dB at two or more contiguous octave frequencies in the study ear at the Screening visit or on the prior audiogram (if the Investigator feels there is not a true conductive hearing loss, the Medical Monitor should be consulted).
- 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 3 months of the screening visit.
- History of clinically significant vestibular symptoms at the discretion of the investigator. For example, BPPV may be considered acceptable whereas Meniere's would not.
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- History of clinically significant systemic autoimmune disease (e.g. rheumatoid arthritis, Sjogren's syndrome, multiple sclerosis, psoriasis).
- Exposure to another investigational drug within 28 days prior to injection of study drug.
- Evidence of any active or chronic disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would pose an unacceptable risk to the subject in the opinion of the investigator following a detailed medical history, physical examination, and vital signs (systolic and diastolic blood pressure, pulse rate, body temperature).
- Females of childbearing potential (those who are not surgically sterilized or post- menopausal) may not participate in the study if any of the following conditions exist:
- Pregnant or intend to become pregnant
- Nursing (lactating)
- Does not agree to use adequate birth control methods for the duration of the study (adequate birth control methods are: hormonal- oral, implantable, transdermal or injectable contraceptives; mechanical- spermicide in conjunction with a barrier such as a condom or diaphragm, IUD, or surgical sterilization of a partner.
- NOTE: all female subjects of childbearing potential must consent to a urine pregnancy test as described in the Schedule of Assessments. Male subjects should use condoms with spermicide during the study or remain abstinent. Subjects should not donate sperm or ova during the study period.
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Clinical Trial Site
Amherst, New York, 00000
Clinical Trial Site
Norfolk, Virginia, 00000
Clinical Trial Site
Novi, Michigan, 00000
Clinical Trial Site
Omaha, Nebraska, 00000
Clinical Trial Site
Orangeburg, South Carolina, 00000
Clinical Trial Site - San Antonio #1
San Antonio, Texas, 00000
Clinical Trial Site - San Antonio #2
San Antonio, Texas, 00000
About this study
Official title: A Phase 1b, Prospective, Randomized, Double-Blind, Placebo- Controlled, Single-Dose, Multicenter, Safety Study of FX-322 Administered by Intratympanic Injection in Adults With Severe Sensorineural Hearing Loss
This is a Phase 1b, prospective, randomized, double-blind, placebo-controlled, single-dose, multicenter, safety study of FX-322, administered by intratympanic injection, in adults with severe sensorineural hearing loss.
Read the detailed description
This is a Phase 1b placebo-controlled, double-blind, single-dose safety study of intratympanic FX-322 dosed in subjects with severe sensorineural hearing loss.
Approximately 30 subjects are planned to be enrolled in this study. The subjects will be randomized to receive one dose FX-322 (24) or placebo (6) and will return for safety, otologic, and audiologic assessments at Days 30 and 90 after the study injection.
- Being tested
- FX-322, Placebo
- Keywords
- Intratympanic administration, Restoration of hearing loss
- Medical subject headings
- Hearing Loss, Sensorineural, Hearing Loss, Noise-Induced, Hearing Loss, Sudden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FX-322Drug
Active Comparator
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| FX-322 | Active comparator | FX-322, 1 dose (N=24) Receives: Drug: FX-322 |
| Placebo | Placebo comparator | Placebo, 1 dose (n=6) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systemic Safety: Number of patients with treatment-related adverse events
Number of patients with treatment-related adverse events assessed by CTCAE v5.0
Measured: 3 months
Local Safety: Number of patients with abnormal changes from baseline in otoscopic examinations
Microscopic otoscopy will be included to specifically record any abnormalities of the external ear canal, tympanic membrane and middle ear.
Measured: 3 months
Local Safety: The number of patients with abnormal changes from baseline in tympanometry
Tympanometry tests the integrity of the tympanic membrane by varying air pressure in the ear canal. Middle ear compliance (mL), peak pressure (daPa), and ear canal volume (mL) will be recorded.
Measured: 3 months
Columbia-Suicide Severity Rating Scale (C-SSRS)
Risk assessment through a series of simple, plain-language questions
Measured: 3 months
Secondary outcomes (5)
Audiologic Response Endpoints: Speech Intelligibility - Word Recognition in Quiet (WR)
Assessment of speech intelligibility using the Word Recognition in Quiet test measured with Consonant-Nucleus-Consonant (CNC) word lists.
Measured: 3 months
Audiologic Response: Speech Intelligibility - Bamford-Kowal-Bench Speech in Noise (BKB-SIN)
Speech intelligibility using the BKB-SIN test measured with a list of sentences presented to the subject.
Measured: 3 months
Standard Pure Tone Audiometry
Standard pure tone audiometry will be measured to determine a subject's threshold for hearing at standard frequencies (Hz)
Measured: 3 months
Extended High Frequency Pure Tone Audiometry
Pure tone audiometry will be measured to determine a subject's threshold for hearing at extended high range frequencies (Hz)
Measured: 3 months
Tinnitus Assessment
Measured by the Tinnitus Functional Index (TFI), with a scale ranging from 0 to 100 that defines severity categories based on 25 self-reported answers.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start2 Nov 2020
- Primary completion26 May 2021
- Study completion20 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, SensorineuralStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Approximately 30 subjects are planned to be enrolled in this study. The subjects will be randomized to receive FX-322 or placebo randomized 4:1.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frequency Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carl LeBel, PhD, Study director, Frequency Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04629664
- Sponsor's protocol ID
- FX-322-113
- Status last verified
- Jan 2022
- First submitted
- 10 Nov 2020
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Prospective, Randomized, Double-Blind, Placebo- Controlled, Single-Dose, Multicenter, Safety Study of FX-322 Administered by Intratympanic Injection in Adults With Severe Sensorineural Hearing Loss
- ClinicalTrials.gov ID
- NCT04629664
- Acronym / sponsor ID
- FX-322-113
- Keywords
- Intratympanic administration, Restoration of hearing loss
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Frequency TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 26 May 2021 (actual)
- Study completion
- 20 Sep 2021 (actual)
- First posted
- 16 Nov 2020 (actual)
- Results
- Not posted in the source record
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 1b, prospective, randomized, double-blind, placebo-controlled, single-dose, multicenter, safety study of FX-322, administered by intratympanic injection, in adults with severe sensorineural hearing loss.
Detailed description
This is a Phase 1b placebo-controlled, double-blind, single-dose safety study of intratympanic FX-322 dosed in subjects with severe sensorineural hearing loss.
Approximately 30 subjects are planned to be enrolled in this study. The subjects will be randomized to receive one dose FX-322 (24) or placebo (6) and will return for safety, otologic, and audiologic assessments at Days 30 and 90 after the study injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Approximately 30 subjects are planned to be enrolled in this study. The subjects will be randomized to receive FX-322 or placebo randomized 4:1.
| Arm | Type | Receives |
|---|---|---|
| FX-322 | Active comparator | Drug: FX-322FX-322, 1 dose (N=24) |
| Placebo | Placebo comparator | Other: PlaceboPlacebo, 1 dose (n=6) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject has read and voluntarily signed the Informed Consent Form (ICF) after all questions have been answered and prior to any study-mandated procedure.
- Adult aged 18-65 years inclusive.
- Documented medical history consistent with acquired (non-genetic) severe sensorineural hearing loss (documented audiogram at least 6 months prior to screening required).
- A pure tone average of 71-90 dB at 500Hz, 1000Hz, 2000Hz, and 4000Hz at Screening in the ear to be injected.
- Ability to communicate well with the Investigator and is willing to comply with and complete all the study procedures.
Key exclusion criteria (15 listed)
- Subject has previously participated in a FX-322 clinical trial.
- 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 study ear. This includes a current tympanostomy tube.
- Any conductive hearing loss of greater than 15 dB at a single frequency or greater than 10 dB at two or more contiguous octave frequencies in the study ear at the Screening visit or on the prior audiogram (if the Investigator feels there is not a true conductive hearing loss, the Medical Monitor should be consulted).
- 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 3 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-322Active Comparator | Drug | FX-322 |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Systemic Safety: Number of patients with treatment-related adverse events
Time frame: 3 months
Number of patients with treatment-related adverse events assessed by CTCAE v5.0
Local Safety: Number of patients with abnormal changes from baseline in otoscopic examinations
Time frame: 3 months
Microscopic otoscopy will be included to specifically record any abnormalities of the external ear canal, tympanic membrane and middle ear.
Local Safety: The number of patients with abnormal changes from baseline in tympanometry
Time frame: 3 months
Tympanometry tests the integrity of the tympanic membrane by varying air pressure in the ear canal. Middle ear compliance (mL), peak pressure (daPa), and ear canal volume (mL) will be recorded.
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: 3 months
Risk assessment through a series of simple, plain-language questions
5 secondary outcomes
Audiologic Response Endpoints: Speech Intelligibility - Word Recognition in Quiet (WR)
Time frame: 3 months
Audiologic Response: Speech Intelligibility - Bamford-Kowal-Bench Speech in Noise (BKB-SIN)
Time frame: 3 months
Standard Pure Tone Audiometry
Time frame: 3 months
Extended High Frequency Pure Tone Audiometry
Time frame: 3 months
Tinnitus Assessment
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
- Individual participant dataSharing planned: No
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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.
Carl LeBel, PhD study director
Frequency Therapeutics
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FX-322 in people with Hearing Loss, Sensorineural and Noise Induced Hearing Loss, run by Frequency Therapeutics at 7 sites 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 5 inclusion and 15 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 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Systemic Safety: Number of patients with treatment-related adverse events (time frame: 3 months). The study lists 4 primary outcomes in all. 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 1 Feb 2022.