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药物开发计划至关重要。在酒精和药物滥用领域有很好的动物和人类实验室范例。国家酒精滥用和酒精中毒研究所（NIAAA）开发了临床前动物模型计划（HHSN 275201400004C和HHSN 275201400005C），以使用各种动物模型筛选有希望的化合物，并建立了NIAAA临床研究者小组（NCIG）计划，以进行概念验证（POC）临床试验。NIAAA的治疗药物开发管道中缺乏一个人类实验室项目，该项目将在进行更昂贵的POC临床试验之前筛选潜在的药物。总体目标是开发一个综合计划，其中将在该计划的所有三个组成部分中测试前瞻性治疗化合物：临床前动物模型，人体实验室测试和POC临床试验。 最初，有前途的化合物将在临床前动物模型计划中进行检查。在临床前试验中证明有效性的化合物（假设满足安全性和耐受性终点）将进入人体实验室筛选项目（HLAB）。如果候选化合物在一种或多种酒精依赖综合征相关方面的人体实验室试验中显示出有希望的结果，则将考虑在NCIG POC临床试验中对预期化合物进行评价。建立用于测试药物的人类实验室计划是实现有效和可预测的药物开发计划以及促进治疗酒精使用障碍（AUDs）的药物的重要组成部分。