Hearing Loss, SensorineuralPhase 1NCT05664100
First in Human Safety Study of FX-345 in Adults With Sensorineural Hearing Loss
A Phase 1 study testing FX-345 in people with Hearing Loss, Sensorineural, run by Frequency Therapeutics at 4 sites in United States.
Trial summary
This single-blind, placebo-controlled trial will be conducted to evaluate the safety of FX-345 administered as a single intratympanic injection in adults with acquired sensorineural hearing loss. Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Hearing Loss, Sensorineural
- What is being tested?
- FX-345
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 4 sitesUnited States
- Study dates
- 15 Dec 2022to 12 Apr 2023
- 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 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult aged 18-67 years (inclusive)
- Documented medical history consistent with acquired, adult onset, sensorineural hearing loss
- At the Screening, Lead-in (Visit 2) and Treatment (Day 1) Visits, a pure tone average of 40- 80 dBHL at 500Hz, 1000Hz, 2000Hz, and 4000Hz in the potential study ear to be injected
- Female participants must not be pregnant, breastfeeding, or lactating. Women of child-bearing potential must agree to use a highly effective contraceptive method and must have a negative urine pregnancy test.
- Male participants must refrain from donating sperm and agree to be either abstinent or use a barrier method of contraception
Who cannot join
- Randomization in a FX-322 (laduviglusib and sodium valproate) 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, Lead-in (Visit 2) or Treatment (Day 1) Visits, based on the investigator's judgment.
- Active chronic middle ear disease or a history of major middle ear surgery, as an adult, in the ear to be injected.
- Within 3 months of screening visit any of the following: 1) an intratympanic injection in either ear 2) treatment with steroids 3) onset of sudden sensorineural hearing loss
- Evidence of or previous diagnosis of traumatic brain injury, Meniere's disease, or genetic hearing loss
- History of head or neck radiation, significant systemic autoimmune disease, and/or chronic, recurrent clinically significant vestibular symptoms
- Exposure to another investigational drug within 28 days prior to screening visit
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Clinical Trial Site
San Antonio, Texas, 78240
Clinical Trial Site
San Antonio, Texas, 78258
Clinical Trial Site
Sarasota, Florida, 34239
Clinical Trial Site
Spartanburg, South Carolina, 29303
About this study
Official title: A Phase 1b, Prospective, Randomized, Single-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety of FX-345 Administered as a Single Intratympanic Injection in Adults With Acquired Adult-Onset Sensorineural Hearing Loss
This single-blind, placebo-controlled trial will be conducted to evaluate the safety of FX-345 administered as a single intratympanic injection in adults with acquired sensorineural hearing loss. The primary objectives are to assess the local safety, systemic safety, and pharmacokinetic (PK) profile to determine systemic exposure.
Read the detailed description
This study will enroll two cohorts. Cohort 1 (n=9) will be enrolled first to rapidly assess safety and drug exposure. After the sponsor completes an unblinded safety review, Cohort 2 (n=27) will be enrolled to continue safety evaluation of FX-345.
- Conditions
- Hearing Loss, Sensorineural
- Being tested
- FX-345, Placebo
- Keywords
- Hearing loss, Intratympanic Injection
- Medical subject headings
- Hearing Loss, Sensorineural, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FX-345Drug
Single intratympanic injection of FX-345
PlaceboDrug
Single intratympanic injection of placebo
| Study group | Role | What they receive |
|---|---|---|
| FX-345 Cohort 1 | Experimental | Patients in the first cohort receiving FX-345 intratympanic injection Receives: Drug: FX-345 |
| Placebo Cohort 1 | Placebo comparator | Patients in the first cohort receiving placebo intratympanic injection Receives: Drug: Placebo |
| FX-345 Cohort 2 | Experimental | Patients in the second cohort receiving FX-345 intratympanic injection Receives: Drug: FX-345 |
| Placebo Cohort 2 | Placebo comparator | Patients in the second cohort receiving placebo 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)
Measured: Baseline Through Day 90
Cmax
Maximum (peak) observed plasma drug concentration of FX04 and FX00 in cohort 1 participants
Measured: Data points taken pre-dose and 0.5, 1, 2, 4, 6, 24 hours post-dose
AUClast
Area under the concentration-time curve of FX04 and FX00 in cohort 1 participants
Measured: Data points taken pre-dose and 0.5, 1, 2, 4, 6, 24 hours post-dose
CL/F
Apparent total body clearance of FX04 and FX00 in cohort 1 participants
Measured: Data points taken pre-dose and 0.5, 1, 2, 4, 6, 24 hours post-dose
Vss
Apparent volume of distribution at steady state of FX04 and FX00 in cohort 1 participants
Measured: Data points taken pre-dose and 0.5, 1, 2, 4, 6, 24 hours post-dose
t1/2
Elimination half-life of FX04 and FX00 in cohort 1 participants
Measured: Data points taken pre-dose and 0.5, 1, 2, 4, 6, 24 hours post-dose
Tmax
Time to reach maximum (peak) plasma drug concentration of FX04 and FX00 in cohort 1 participants
Measured: Data points taken pre-dose and 0.5, 1, 2, 4, 6, 24 hours post-dose
Elimination rate constant
The rate at which FX04 and FX00 is removed from the human system in cohort 1 participants
Measured: Data points taken pre-dose and 0.5, 1, 2, 4, 6, 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 posted23 Dec 2022
- Study start15 Dec 2022
- Primary completion12 Apr 2023
- Study completion12 Apr 2023
Why it stopped: Business reasons
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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 6 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
- NCT05664100
- Sponsor's protocol ID
- FX-345-101
- Status last verified
- Apr 2023
- First submitted
- 13 Dec 2022
- Last updated
- 27 Apr 2023
- Results posted
- No
- 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 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Prospective, Randomized, Single-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety of FX-345 Administered as a Single Intratympanic Injection in Adults With Acquired Adult-Onset Sensorineural Hearing Loss
- ClinicalTrials.gov ID
- NCT05664100
- Acronym / sponsor ID
- FX-345-101
- Conditions
- Hearing Loss, Sensorineural
- Keywords
- Hearing loss, Intratympanic Injection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business reasons
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Frequency TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 12 Apr 2023 (actual)
- Study completion
- 12 Apr 2023 (actual)
- First posted
- 23 Dec 2022 (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 single-blind, placebo-controlled trial will be conducted to evaluate the safety of FX-345 administered as a single intratympanic injection in adults with acquired sensorineural hearing loss. The primary objectives are to assess the local safety, systemic safety, and pharmacokinetic (PK) profile to determine systemic exposure.
Detailed description
This study will enroll two cohorts. Cohort 1 (n=9) will be enrolled first to rapidly assess safety and drug exposure. After the sponsor completes an unblinded safety review, Cohort 2 (n=27) will be enrolled to continue safety evaluation of FX-345.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| FX-345 Cohort 1 | Experimental | Drug: FX-345Patients in the first cohort receiving FX-345 intratympanic injection |
| Placebo Cohort 1 | Placebo comparator | Drug: PlaceboPatients in the first cohort receiving placebo intratympanic injection |
| FX-345 Cohort 2 | Experimental | Drug: FX-345Patients in the second cohort receiving FX-345 intratympanic injection |
| Placebo Cohort 2 | Placebo comparator | Drug: PlaceboPatients in the second cohort receiving placebo intratympanic injection |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult aged 18-67 years (inclusive)
- Documented medical history consistent with acquired, adult onset, sensorineural hearing loss
- At the Screening, Lead-in (Visit 2) and Treatment (Day 1) Visits, a pure tone average of 40- 80 dBHL at 500Hz, 1000Hz, 2000Hz, and 4000Hz in the potential study ear to be injected
- Female participants must not be pregnant, breastfeeding, or lactating. Women of child-bearing potential must agree to use a highly effective contraceptive method and must have a negative urine pregnancy test.
- Male participants must refrain from donating sperm and agree to be either abstinent or use a barrier method of contraception
Key exclusion criteria (8 listed)
- Randomization in a FX-322 (laduviglusib and sodium valproate) 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, Lead-in (Visit 2) or Treatment (Day 1) Visits, based on the investigator's judgment.
- Active chronic middle ear disease or a history of major middle ear surgery, as an adult, in the ear to be injected.
- Within 3 months of screening visit any of the following: 1) an intratympanic injection in either ear 2) treatment with steroids 3) onset of sudden sensorineural hearing loss
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-345Single intratympanic injection of FX-345 | Drug | FX-345 Cohort 1, FX-345 Cohort 2 |
| PlaceboSingle intratympanic injection of placebo | Drug | Placebo Cohort 1, Placebo Cohort 2 |
Primary outcome
Number of Participants With Treatment-emergent Adverse Event(s) (TEAEs)
Time frame: Baseline Through Day 90
Cmax
Time frame: Data points taken pre-dose and 0.5, 1, 2, 4, 6, 24 hours post-dose
Maximum (peak) observed plasma drug concentration of FX04 and FX00 in cohort 1 participants
AUClast
Time frame: Data points taken pre-dose and 0.5, 1, 2, 4, 6, 24 hours post-dose
Area under the concentration-time curve of FX04 and FX00 in cohort 1 participants
CL/F
Time frame: Data points taken pre-dose and 0.5, 1, 2, 4, 6, 24 hours post-dose
Apparent total body clearance of FX04 and FX00 in cohort 1 participants
Vss
Time frame: Data points taken pre-dose and 0.5, 1, 2, 4, 6, 24 hours post-dose
Apparent volume of distribution at steady state of FX04 and FX00 in cohort 1 participants
t1/2
Time frame: Data points taken pre-dose and 0.5, 1, 2, 4, 6, 24 hours post-dose
Elimination half-life of FX04 and FX00 in cohort 1 participants
Tmax
Time frame: Data points taken pre-dose and 0.5, 1, 2, 4, 6, 24 hours post-dose
Time to reach maximum (peak) plasma drug concentration of FX04 and FX00 in cohort 1 participants
Elimination rate constant
Time frame: Data points taken pre-dose and 0.5, 1, 2, 4, 6, 24 hours post-dose
The rate at which FX04 and FX00 is removed from the human system in cohort 1 participants
Results and safety
The study was stopped early (reason given: Business reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
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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
4 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-345 in people with Hearing Loss, Sensorineural, run by Frequency Therapeutics at 4 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 8 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: stopped early, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 was stopped early (reason given: Business reasons). Results are not available in the source record.
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). The study lists 8 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 27 Apr 2023.