ADVANCED DEVELOPMENT OF BBT-059 AS A RADIATION MEDICAL COUNTERMEASURE FOR DOSING UP TO 48H POST EXPOSURE"
ADVANCED DEVELOPMENT OF BBT-059 AS A RADIATION MEDICAL COUNTERMEASURE FOR DOSING UP TO 48H POST EXPOSURE"
BBT-059 的先进开发，作为辐射医学对策，可在暴露后 48 小时内进行给药”
批准号：
10932514
负责人：
GEORGE COX
金额：
$165.08万
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
项目状态：
已结题
起止时间：
2023-07-01 至 2024-06-30
关键词：
AcuteAdvanced DevelopmentAnimalsBiotechnologyBlood specimenDevelopmentDoseEnzyme-Linked Immunosorbent AssayFormulationGMP lotsHematopoieticHistopathologyHumanInterleukin-11Investigational DrugsInvestigational New Drug ApplicationMeasuresMusPhase I Clinical TrialsPlasmaProtocols documentationQualifyingRadiationRadiation ToxicityRadiation exposureReference StandardsReportingResearch ContractsSafetySamplingStatistical Data InterpretationTestingTimeTissuesToxicokineticsToxicologyUnited States Food and Drug AdministrationWorkWritinganalogclinical trial protocolhuman subjectmanufacturemedical countermeasureprotocol developmentstability testing
中文摘要
翻译
BBT-059是一种长效IL-11类似物，当在急性辐射暴露后48小时给药时，可减轻造血急性辐射综合征（HARS），此时大多数其他H-ARS医学对策（MCM）无效。要约人提议完成BBT-059的IND使能安全毒理学研究，生产BBT-059的GMP批次，并向美国食品药品监督管理局（FDA）撰写和提交研究性新药（IND）申请，以开始在人体中测试BBT-059。
英文摘要
BBT-059, a long-acting IL-11 analog, mitigates hematopoietic acute radiation syndrome (HARS) when administered as late as 48h following acute radiation exposure, a time when most other H-ARS medical countermeasures (MCMs) are not effective. The offeror proposes to complete IND-enabling safety toxicology studies of BBT-059, manufacture a GMP lot of BBT-059, and write and submit an Investigational New Drug (IND) application to the Food and Drug Administration (FDA) to begin testing BBT-059 in humans.
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