grant
Development of the anti-fentanyl monoclonal antibody, CSX-1004, for prophylaxis against fentanyl and fentanyl analog overdose
Organization CESSATION THERAPEUTICS, LLCLocation SAN JOSE, UNITED STATESPosted 15 Sept 2025Deadline 31 Jul 2028
NIHUS FederalResearch GrantFY202521+ years oldAcademic Medical CentersActiqAcuteAdultAdult HumanAmericanAnesthesiaAnesthesia proceduresApneaApplications GrantsAuthorizationAuthorization documentationBindingBioavailabilityBiological AvailabilityBlood SerumChest WallChest wall structureClinicalClinical DataClinical ResearchClinical StudyClinical Treatment MoabConcentration measurementDataData BasesDatabasesDevelopmentDiacetylmorphineDiamorphineDihydrohydroxycodeinoneDoseDrug KineticsDrugsDuragesicExhibitsFentanestFentanylFentylFormulationGrant ProposalsHalf-LifeHeroinHu-mABsHumanHuman VolunteersHyperkinesiaHyperkinesisHyperkinetic MovementsIND FilingIND applicationIND packageIND submissionIgG1IncidenceInvestigational New Drug ApplicationLaboratoriesLaryngismusLaryngospasmLifeMedicalMedicationModern ManMolecular InteractionMonoclonal AntibodiesMuscle SpasmMuscular SpasmNaloxoneNarcanNarcantiO elementO2 elementOpiatesOpioidOverdoseOverdose reversalOxycodeinonOxycodoneOxycodone SROxycontinOxygenPain ResearchPatientsPermissionPharmaceutical PreparationsPharmacokineticsPharmacologyPhasePhentanylPhysiologic AvailabilityPreclinical dataProgram DevelopmentProphylactic treatmentProphylaxisRandomizedResearch DesignResistanceRespiratory DepressionRoxicodoneSafetySerumSpasmSpeedStudy TypeSubcutaneous InjectionsTestingTherapeuticThoracic WallTimeToxicologyUnited StatesUniversity Medical CentersVentilatory DepressionVocal Foldadulthoodapnea caused by fentanylattenuationclinical developmentcohortdata basedepressed breathingdepression of breathingdevelopmentaldrug/agentfentalogsfentaloguesfentanyl analogfentanyl evoked respiratory depressionfentanyl induced apneafentanyl induced hypoventilationfentanyl induced respiratory depressionfentanyl induced ventilatory depressionfentanyl mediated respiratory depressionfentanyl overdosefentanyl respiratory depressionfirst in manfirst-in-humanhealth care settingshumAbshuman mAbshuman monoclonal antibodieshuman monoclonalshuman subjectimmunogenicitymAbsmanufacturemeetingmeetingsmonoclonal Absnew drug treatmentsnew drugsnew pharmacological therapeuticnew therapeuticsnew therapynext generation therapeuticsnon-human primatenonhuman primatenovelnovel drug treatmentsnovel drugsnovel pharmaco-therapeuticnovel pharmacological therapeuticnovel therapeuticsnovel therapyopiate crisisopiate overdoseopiate related overdoseopiate use disorderopioid crisisopioid drug overdoseopioid epidemicopioid induced overdoseopioid intoxicationopioid medication overdoseopioid overdoseopioid poisoningopioid related overdoseopioid toxicityopioid use disorderoverdose deathoverdose fatalitiespreclinical findingspreclinical informationpreventpreventingprimary end pointprimary endpointrandomisationrandomizationrandomly assignedresistantrespiratoryrespiratory depression caused by fentanylresponsereverse overdosesafety studystudy designsubcutaneoussubdermalsubdermal injectionsynthetic opiatesynthetic opioidvocal cord
Description preview
The opioid crisis in the United States has been dominated by illicitly manufactured fentanyl for a majority of the last decade, during which time over 400,000 Americans have died from unintentional overdose due to fentanyl or fentanyl analogs. The overdose reversal agent, naloxone, has been the cornerstone of opioid overdose management since 1971;…
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