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Latest updates to the FX-322 Safety Study in Cochlear Implantation Clinical Trial page
- CheckyesterdayNo Change Detected
- Check2 days agoNo Change Detected
- Check3 days agoNo Change Detected
- Check4 days agoChange DetectedThe study has been updated to version v2.10.0, replacing the previous version v2.9.7.SummaryDifference0.7%
- Check5 days agoNo Change Detected
- Check11 days agoChange DetectedThe website has been updated to Revision v2.9.7 from v2.9.6.SummaryDifference0.1%
- Check25 days agoChange DetectedThe value of Revision has been updated from v2.9.5 to v2.9.6, indicating a recent revision in the content of the webpage.SummaryDifference0.1%
- Check30 days agoChange DetectedThe value of Revision has been updated from v2.9.3 to v2.9.5, indicating a recent revision in the content of the webpage.SummaryDifference0.1%
- Check31 days agoChange DetectedThe value of Revision has been updated from v2.9.1 to v2.9.3, indicating a recent revision in the content of the webpage.SummaryDifference0.1%
- Check32 days agoChange DetectedThe 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.SummaryDifference21%
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