First in Human Safety Study of FX-322 in Adults Undergoing Cochlear Implantation
1 other identifier
interventional
9
1 country
1
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for early_phase_1
Started May 2017
Shorter than P25 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 30, 2017
CompletedFirst Submitted
Initial submission to the registry
September 15, 2017
CompletedFirst Posted
Study publicly available on registry
October 3, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 12, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 18, 2018
CompletedApril 12, 2018
April 1, 2018
7 months
September 15, 2017
April 11, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Treatment-emergent adverse events will be assessed over a several hour to two week period
Secondary Outcomes (3)
Plasma Pharmacokinetics
Systemic exposure will be evaluated over a 72 hour period
Plasma Pharmacokinetics
Within a 24 hour period after injection
Cochlear Perilymph Pharmacokinetics
within a 24 hour period after injection
Study Arms (2)
Active
ACTIVE COMPARATORSubjects will receive FX-322 as an intratympanic injection
Placebo
PLACEBO COMPARATORSubjects will receive Placebo as an intratympanic injection
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Royal Victoria Eye and Ear Hospital
Melbourne, Victoria, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2017
First Posted
October 3, 2017
Study Start
May 30, 2017
Primary Completion
December 12, 2017
Study Completion
January 18, 2018
Last Updated
April 12, 2018
Record last verified: 2018-04