Hearing LossEarly Phase 1NCT03300687
First in Human Safety Study of FX-322 in Adults Undergoing Cochlear Implantation
A Early Phase 1 study testing FX-322 in people with Hearing Loss, run by Frequency Therapeutics at 1 site in Australia.
Trial summary
This is a phase 1 safety study performed in male or female adult participants with an established diagnosis of severe to profound sensorineural hearing loss that meets the criteria for cochlear implantation and the participant has already chosen to undergo cochlear implant surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- 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
- 9 participants
- Where
- 1 siteAustralia
- Study dates
- 30 May 2017to 18 Jan 2018
- Phase
- Early 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female adult subjects with an established diagnosis of severe to profound sensorineural hearing loss audiometric threshold of 80 dB HL or poorer at 500 Hz that meets the criteria for cochlear implantation and the subject has already chosen to undergo cochlear implant surgery.
- Willingness and ability to comply with scheduled visits, ear examination, drug administration plan, auditory and laboratory tests, study restrictions, and all study procedures.
- Other protocol-defined inclusion criteria may apply
Who cannot join
- Persistent perforation of tympanic membrane or other tympanic membrane disorder that would interfere with the delivery and safety assessment of an intra -tympanic medication or reasonably be suspected to affect tympanic membrane healing after injection.
- Any conductive component defined as air-bone gaps >10 dB at two or more frequencies.
- Other protocol-defined exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
This is a phase 1 safety study performed in male or female adult participants with an established diagnosis of severe to profound sensorineural hearing loss that meets the criteria for cochlear implantation and the participant has already chosen to undergo cochlear implant surgery.
Read the detailed description
Approximately 12 participants will be enrolled in the study. Assessed will be safety and tolerability of FX-322 administered by intratympanic injection. Also assessed will be the FX-322 concentration in cochlear fluid (perilymph), the pharmacokinetic (PK) profile of FX-322 to determine the systemic exposure to FX-322.
- Conditions
- Hearing Loss
- Being tested
- FX-322, Placebo
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FX-322Drug
intratympanic injection
PlaceboDrug
intratympanic injection
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | Subjects will receive FX-322 as an intratympanic injection Receives: Drug: FX-322 |
| Placebo | Placebo comparator | Subjects will receive Placebo as an intratympanic injection Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events (Safety and Tolerability) of FX-322.
To assess the incidence of adverse safety events (vertigo, tinnitus, perforation) including severe adverse events.
Measured: Treatment-emergent adverse events will be assessed over a several hour to two week period
Secondary outcomes (3)
Plasma Pharmacokinetics
Drug exposure in the systemic circulation by evaluating Cmax and AUC Drug exposure evaluated by area under the plasma concentration versus time curve (AUC)
Measured: Systemic exposure will be evaluated over a 72 hour period
Plasma Pharmacokinetics
Peak Plasma Concentration (Cmax)
Measured: Within a 24 hour period after injection
Cochlear Perilymph Pharmacokinetics
single time point measurement in each patient of drug in cochlear perilymph
Measured: within a 24 hour period after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start30 May 2017
- Primary completion12 Dec 2017
- Study completion18 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frequency Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03300687
- Sponsor's protocol ID
- FX-322-103
- Status last verified
- Apr 2018
- First submitted
- 15 Sep 2017
- Last updated
- 12 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First in Human Safety Study of FX-322 in Adults Undergoing Cochlear Implantation
- ClinicalTrials.gov ID
- NCT03300687
- Acronym / sponsor ID
- FX-322-103
- Conditions
- Hearing Loss
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Frequency TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 30 May 2017 (actual)
- Primary completion
- 12 Dec 2017 (actual)
- Study completion
- 18 Jan 2018 (actual)
- First posted
- 3 Oct 2017 (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 1 safety study performed in male or female adult participants with an established diagnosis of severe to profound sensorineural hearing loss that meets the criteria for cochlear implantation and the participant has already chosen to undergo cochlear implant surgery.
Detailed description
Approximately 12 participants will be enrolled in the study. Assessed will be safety and tolerability of FX-322 administered by intratympanic injection. Also assessed will be the FX-322 concentration in cochlear fluid (perilymph), the pharmacokinetic (PK) profile of FX-322 to determine the systemic exposure to FX-322.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Drug: FX-322Subjects will receive FX-322 as an intratympanic injection |
| Placebo | Placebo comparator | Drug: PlaceboSubjects will receive Placebo as an intratympanic injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female adult subjects with an established diagnosis of severe to profound sensorineural hearing loss audiometric threshold of 80 dB HL or poorer at 500 Hz that meets the criteria for cochlear implantation and the subject has already chosen to undergo cochlear implant surgery.
- Willingness and ability to comply with scheduled visits, ear examination, drug administration plan, auditory and laboratory tests, study restrictions, and all study procedures.
- Other protocol-defined inclusion criteria may apply
Key exclusion criteria (3 listed)
- Persistent perforation of tympanic membrane or other tympanic membrane disorder that would interfere with the delivery and safety assessment of an intra -tympanic medication or reasonably be suspected to affect tympanic membrane healing after injection.
- Any conductive component defined as air-bone gaps >10 dB at two or more frequencies.
- Other protocol-defined exclusion criteria may apply
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 | Drug | Active |
| Placebointratympanic injection | Drug | Placebo |
Primary outcome
Incidence of treatment-emergent adverse events (Safety and Tolerability) of FX-322.
Time frame: Treatment-emergent adverse events will be assessed over a several hour to two week period
To assess the incidence of adverse safety events (vertigo, tinnitus, perforation) including severe adverse events.
3 secondary outcomes
Plasma Pharmacokinetics
Time frame: Systemic exposure will be evaluated over a 72 hour period
Plasma Pharmacokinetics
Time frame: Within a 24 hour period after injection
Cochlear Perilymph Pharmacokinetics
Time frame: within a 24 hour period after injection
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 12 Apr 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing FX-322 in people with Hearing Loss, run by Frequency Therapeutics at 1 site in Australia.
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 3 inclusion and 3 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 12 Apr 2018. 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 Australia. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Incidence of treatment-emergent adverse events (Safety and Tolerability) of FX-322. (time frame: Treatment-emergent adverse events will be assessed over a several hour to two week period). 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 12 Apr 2018.