An Early Phase 1 interventional study of FX-322 and Placebo in Hearing Loss, sponsored by Frequency Therapeutics. Completed at 1 site in Australia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-12.
Sponsored by Frequency Therapeutics · Early Phase 1, Interventional, and Other
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.
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.
796 studies on the registry are indexed under Hearing Loss; 193 are open to participants now.
This study's enrollment of 9 is below the median of 44 across 561 interventional studies indexed under Hearing Loss.
Browse Hearing Loss studies →Frequency Therapeutics is the lead sponsor of 7 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 3 (50%) have results posted.
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Other protocol-defined inclusion criteria may apply
Exclusion Criteria:
Other protocol-defined exclusion criteria may apply
Subjects will receive FX-322 as an intratympanic injection
Drug: FX-322
Subjects will receive Placebo as an intratympanic injection
Drug: Placebo
intratympanic injection
intratympanic injection
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.
Time frame: Treatment-emergent adverse events will be assessed over a several hour to two week period
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)
Time frame: Systemic exposure will be evaluated over a 72 hour period
Plasma Pharmacokinetics
Peak Plasma Concentration (Cmax)
Time frame: Within a 24 hour period after injection
Cochlear Perilymph Pharmacokinetics
single time point measurement in each patient of drug in cochlear perilymph
Time frame: within a 24 hour period after injection
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: FX-322
Frequency Therapeutics