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: BOLDER BIOTECHNOLOGY, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-01 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10932514
• 关键词: Acute; Advanced Development; Animals; Biotechnology; Blood specimen; Development; Dose; Enzyme-Linked Immunosorbent Assay; Formulation; GMP lots; Hematopoietic; Histopathology; Human; Interleukin-11; Investigational Drugs; Investigational New Drug Application; Measures; Mus; Phase I Clinical Trials; Plasma; Protocols documentation; Qualifying; Radiation; Radiation Toxicity; Radiation exposure; Reference Standards; Reporting; Research Contracts; Safety; Sampling; Statistical Data Interpretation; Testing; Time; Tissues; Toxicokinetics; Toxicology; United States Food and Drug Administration; Work; Writing; analog; clinical trial protocol; human subject; manufacture; medical countermeasure; protocol development; stability testing

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.

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。