IGF::OT::IGFYale UniversityHHSN275201400007IHHSN27500001

IGF::OT::IGF耶鲁大学HHSN275201400007IHHSN27500001

• 批准号: 9157942
• 负责人: SUCHITRA KRISHNAN-SARIN
• 金额: $ 0.61万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-28 至 2020-09-27
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9157942
• 关键词: Alcohol abuse; Alcohols; Animal Model; Animals; Biological Assay; Clinical; Clinical Investigator; Clinical Trials; Contracts; Data; Data Reporting; Development; Drug Compounding; Evaluation; Goals; Human; Individual; Laboratories; National Institute on Alcohol Abuse and Alcoholism; Outcome; Pharmaceutical Preparations; Program Development; Safety; Substance abuse problem; Syndrome; Testing; Therapeutic; alcohol use disorder; base; clinical research site; drug candidate; drug development; meetings; pre-clinical; predictive modeling; programs; prospective; screening

Screening models that are predictive of clinical outcome are essential to a medications development program. There are excellent animal and human laboratory paradigms in the alcohol and substance abuse fields. A preclinical animal model program (HHSN275201400004C and HHSN275201400005C) at the National Institute on Alcohol Abuse and Alcoholism (NIAAA) was developed to screen promising compounds using various animal models and the NIAAA Clinical Investigators Group (NCIG) program was established to conduct proof-of- concept (POC) clinical trials. Lacking in NIAAA’s therapeutic drug development pipeline is a human laboratory program which will serve to screen potential medications prior to conducting the more expensive POC clinical trials. The overarching goal is to develop an integrated program wherein a prospective therapeutic compound would be tested across all three components of the program: pre-clinical animal models, human laboratory testing, and POC clinical trial. Initially, promising compounds would be examined in the preclinical animal model program. Those compounds which demonstrate efficacy in the preclinical assays (assuming safety and tolerability endpoints are met) would be advanced to the human laboratory screening program (HLAB). If the candidate compound demonstrates promising results in one or more of human laboratory assays underlying aspects of the alcohol ependence syndrome, then the prospective compound would be considered for evaluation in the NCIG POC clinical trials. Establishment of a human laboratory program for testing medications is a valuable, needed component in achieving an efficient and predictable medication development program and for the advancement of medications to treat Alcohol Use Disorders (AUDs).

预测临床结果的筛选模型对于药物开发计划至关重要。国家酒精滥用和滥用研究所有一个临床前动物模型计划（HHSN275201400004C 和 HHSN275201400005C）。酒精中毒 (NIAAA) 旨在利用各种动物模型筛选有前景的化合物，并建立了 NIAAA 临床研究小组 (NCIG) 计划进行概念验证 (POC) 临床试验 NIAAA 的治疗药物开发流程中缺乏的是人体实验室计划，该计划将用于在进行更昂贵的 POC 临床试验之前筛选潜在的药物。计划将是一种潜在的化合物，将在该计划的所有三个组成部分进行测试：临床前动物模型、人体实验室测试和 POC 临床试验。最初，有前途的治疗化合物将在临床前动物模型计划中进行检查。证明功效如果候选化合物在酒精依赖综合征的一项或多项人体实验室检测中显示出有希望的结果，则临床前检测（假设满足安全性和耐受性终点）将被推进到人类实验室筛选计划（HLAB）中。化合物将被考虑在 NCIG POC 临床试验中进行评估。建立用于测试药物的人体实验室计划是实现有效的药物开发计划以及改进治疗酒精使用障碍的药物的一个有价值的、必要的组成部分。 （澳元）。