Development of Inhaled CPZEN-45 For Tuberculosis Therapy
Development of Inhaled CPZEN-45 For Tuberculosis Therapy
批准号:
10348204
负责人:
Diana M Severynse-Stevens
金额:
$121.07万
依托单位国家:
美国
项目类别:
财政年份:
2019
资助国家:
美国
项目状态:
未结题
起止时间:
2019-03-01 至 2025-02-28
关键词:
AerosolsAnimal ModelAnimalsCanis familiarisCessation of lifeChemistryClinical ResearchCommunicable DiseasesDataDevelopmentDiseaseDoseDrug KineticsEnvironmentExtreme drug resistant tuberculosisHIVIncidenceInhalationInternationalInvestigational DrugsInvestigational New Drug ApplicationLungMedicalMethodsMinimum Inhibitory Concentration measurementMulti-Drug ResistanceMultidrug-Resistant TuberculosisMycobacterium tuberculosisNOELOrganismPatientsPerformancePersonsPharmaceutical PreparationsPhasePhase I Clinical TrialsPopulationPreparationProduct ApprovalsRattusResearch ActivityResearch InstituteRouteSafetySubcutaneous InjectionsTechniquesToxic effectToxicologyTuberculosisUnited States Food and Drug AdministrationValidationanalytical methodco-infectiondata managementdrug developmentexperimental studyfirst-in-humangood laboratory practiceguinea pig modelin vivomanufacturing facilitymeetingsmouse modelnovel therapeuticspatient populationpre-clinicalpreclinical studyprotocol developmentrespiratoryscale upsubcutaneoustuberculosis treatmentvaccine development
中文摘要
项目总结/文摘
英文摘要
PROJECT SUMMARY/ABSTRACT
Tuberculosis (TB) is an insidious disease that kills between 1.5–2.0 million people annually. The increase in
multiple and extensively drug-resistant TB globally presents an urgent unmet medical need that is
underserved by the pace of new drug and vaccine development. Following a decade of research activity,
CPZEN-45, a caprazamycin derivative, has been shown to be safe and efficacious when administered via
both the subcutaneous and pulmonary routes in animals. The pulmonary route of administration is more
desirable than subcutaneous delivery because it is non-invasive and more acceptable to the severely
compromised target patient population. CPZEN-45 is poised for development in formal preclinical and initial
clinical studies. It is proposed that in supporting scale up and technical transfer to a current Good
Manufacturing Practice (cGMP) manufacturing facility, the performance of current Good Laboratory Practice
(cGLP) preclinical toxicology studies and preparation of Investigational New Drug (IND) Application
documents to support a Phase I single-dose escalating tolerability study would meet U.S. Food and Drug
Administration (FDA) requirements for product approval. The experiments required to complete the IND
materials are as follows: Specific Aim 1—Scale up and technical transfer of spray dried CPZEN-45 (scale up,
technical transfer to a cGMP environment, development of validated analytical methods); Specific Aim 2—
cGMP rat and dog 14-day toxicology studies (aerosol characterization, rat and dog studies, validated
bioanalytical methods); Specific Aim 3—Document preparation and project management to support pre-IND
meeting with the FDA (chemistry, manufacturing, and controls; data management; preclinical toxicology
studies; data management, Phase I—Protocol development; single-dose escalation study of tolerability and
pharmacokinetics).
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会议论文
Coordinating Center for the NHLBI Catalyze Program
-
批准号:10684451
-
项目类别:
-
资助金额:$240.54万
-
财政年份:2020
-
负责人:Diana M Severynse-Stevens
-
依托单位:
Coordinating Center for the NHLBI Catalyze Program
-
批准号:10209507
-
项目类别:
-
资助金额:$189.76万
-
财政年份:2020
-
负责人:Diana M Severynse-Stevens
-
依托单位:
Coordinating Center for the NHLBI Catalyze Program
-
批准号:10460683
-
项目类别:
-
资助金额:$191.88万
-
财政年份:2020
-
负责人:Diana M Severynse-Stevens
-
依托单位:
Pediatric Preclinical Testing Consortium: Coordinating Center
-
批准号:8967492
-
项目类别:
-
资助金额:$48.77万
-
财政年份:2015
-
负责人:Diana M Severynse-Stevens
-
依托单位:
海外基金