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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03300687




Registration number
NCT03300687
Ethics application status
Date submitted
15/09/2017
Date registered
3/10/2017
Date last updated
12/04/2018

Titles & IDs
Public title
First in Human Safety Study of FX-322 in Adults Undergoing Cochlear Implantation
Scientific title
First in Human Safety Study of FX-322 in Adults Undergoing Cochlear Implantation
Secondary ID [1] 0 0
FX-322-103
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hearing Loss 0 0
Condition category
Condition code
Ear 0 0 0 0
Deafness

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - FX-322
Treatment: Drugs - Placebo

Active Comparator: Active - Subjects will receive FX-322 as an intratympanic injection

Placebo Comparator: Placebo - Subjects will receive Placebo as an intratympanic injection


Treatment: Drugs: FX-322
intratympanic injection

Treatment: Drugs: Placebo
intratympanic injection

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Treatment-emergent adverse events will be assessed over a several hour to two week period
Secondary outcome [1] 0 0
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)
Timepoint [1] 0 0
Systemic exposure will be evaluated over a 72 hour period
Secondary outcome [2] 0 0
Plasma Pharmacokinetics - Peak Plasma Concentration (Cmax)
Timepoint [2] 0 0
Within a 24 hour period after injection
Secondary outcome [3] 0 0
Cochlear Perilymph Pharmacokinetics - single time point measurement in each patient of drug in cochlear perilymph
Timepoint [3] 0 0
within a 24 hour period after injection

Eligibility
Key inclusion criteria
1. 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.

2. 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. 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.

2. Any conductive component defined as air-bone gaps >10 dB at two or more frequencies.

Other protocol-defined exclusion criteria may apply

Study design
Purpose of the study
Other
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Single group
Other design features
Phase
Phase 0
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Royal Victoria Eye and Ear Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Frequency Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/show/NCT03300687
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications