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Latest updates to the FX-322 Safety Study in Cochlear Implantation Clinical Trial page

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    Summary
    The study has been updated to version v2.10.0, replacing the previous version v2.9.7.
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    Check dated 2024-07-23T13:25:29.000Z thumbnail image
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    The value of Revision has been updated from v2.9.5 to v2.9.6, indicating a recent revision in the content of the webpage.
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    32 days ago
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    Summary
    The value 'Show more Revision: v2.9.0' has been updated to 'MedlinePlus related topics: Cochlear Implants Safety FDA Drug and Device Resources Show less Design Details Primary Purpose : Other Allocation : Non-Randomized Interventional Model : Single Group Assignment Masking : Single ( Participant ) Arms and Interventions Participant Group/Arm Intervention/Treatment Active Comparator : Active Subjects will receive FX-322 as an intratympanic injection Drug : FX-322 intratympanic injection Placebo Comparator : Placebo Subjects will receive Placebo as an intratympanic injection Drug : Placebo intratympanic injection Primary Outcome Measures Outcome Measure Measure Description Time Frame 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 Outcome Measures Outcome Measure Measure Description Time Frame 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) Systemic exposure will be evaluated over a 72 hour period Plasma Pharmacokinetics Peak Plasma Concentration (Cmax) Within a 24 hour period after injection Cochlear Perilymph Pharmacokinetics single time point measurement in each patient of drug in cochlear perilymph within a 24 hour period after injection'. This change represents an update in the study details and outcomes related to the safety and pharmacokinetics of FX-322 in adults undergoing cochlear implantation.
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    Check dated 2024-06-25T07:41:51.000Z thumbnail image

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