Base Title: PREVENT Preclinical Pharmacology and ToxicologyTask Order Title: Nicotine Reduction Therapy Using the Human Monoclonal Antibody ATI-1013

基本标题：预防临床前药理学和毒理学任务订单标题：使用人单克隆抗体 ATI-1013 进行尼古丁减少治疗

• 批准号: 10932479
• 负责人: DAVID MCCORMICK
• 金额: $ 65.95万
• 依托单位: IIT RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-22 至 2024-05-21
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10932479
• 关键词: Adopted; American Association of Cancer Research; Animal Cancer Model; Antibodies; Binding; Biological Assay; Biological Products; CCL2 gene; Canis familiaris; Cellular Assay; Clinical Chemistry; Communities; Consultations; Contractor; Contracts; Development; Dose; Drug Kinetics; Enzyme-Linked Immunosorbent Assay; European; Evaluation; Exposure to; Frequencies; Funding; Guidelines; Half-Life; Hematology; Human; Human Resources; IL17 gene; IL8 gene; In Vitro; Incubated; Interferons; Interleukin-10; Interleukin-2; Interleukin-6; Intravenous; Investigation; Lesion; Malignant Neoplasms; Maximum Tolerated Dose; Measures; Medicine; Methods; Mission; Monoclonal Antibodies; Nicotine; Notification; Organ; Pathology; Peripheral Blood Mononuclear Cell; Pharmaceutical Preparations; Pharmacology; Principal Investigator; Production; Progress Reports; Rattus; Recommendation; Reporting; Research; Route; Sampling; Serum; Slide; Specific qualifier value; Technology; Testing; Tissues; Toxicology; Travel; base; cancer prevention; carcinogenesis; clinical translation; cross reactivity; cytokine; cytotoxicity; human monoclonal antibodies; human tissue; immunogenic; immunogenicity; innovation; manufacture; meetings; nonhuman primate; novel; posters; pre-clinical; preventive intervention; programs; research and development; symposium; vaccinology

The objectives of this Task Order are to: 1. Determine the cross-reactivity of ATI-1013 in major organs/tissues of humans, rats, dogs, and non-human primates. 2. Assess immunogenicity of ATI-1013 in a peripheral blood mononuclear cell assay. 3. Conduct a dose range finding and pharmacokinetics study in rats to determine the maximum feasible/tolerated dose of ATI-1013 and single-dose ATI-1013 pharmacokinetics at that dose. 4. Investigate the production of antidrug antibodies (ADA) to ATI-1013. 5. Disseminate research findings.

本任务指令的目标是： 1. 测定ATI-1013在人、大鼠、犬和非人灵长类动物主要器官/组织中的交叉反应性。 2. 在外周血单核细胞试验中评估ATI-1013的免疫原性。 3. 在大鼠中进行剂量范围探索和药代动力学研究，以确定ATI-1013的最大可行/耐受剂量和该剂量下ATI-1013单次给药的药代动力学。 4. 研究ATI-1013抗药抗体（ADA）的产生。 5. 传播研究成果。