STAMPOUT: A Phase 2a Study of Antibody for Methamphetamine Outpatient Therapy

美国FDA尚未批准任何用于治疗甲基苯丙胺（METH）使用障碍的药物。 目前，认知行为和应急管理干预是最有效的治疗方法。 IXT-m200是一种特异性结合血液中METH的单克隆抗体，正在开发作为一种 与行为疗法联合使用的药物治疗。基于非临床研究， 预期IXT-m200会改变人类受试者中的METH药代动力学，导致METH代谢减少或阻断。 METH主观效果，加强METH的使用。STAMPOUT，一项针对以下疾病的抗体的2a期研究 甲基苯丙胺门诊治疗，将提供IXT-m200可以改变METH的概念验证 处分这是在进行大规模疗效研究之前需要的。该申请提出了第一个临床 在METH使用者中进行的一项针对METH使用障碍患者开发的生物药物研究。 本申请的主要目的是显示METH抗体将改变METH在小鼠体内的药代动力学。 使用者和减少强化的主观效果，使METH的使用永久化。在STAMPOUT研究期间， 使用METH的受试者将接受单次剂量的IXT-m200，然后每周接受METH攻击。连续血液 将分析样本和尿液收集，以确定由于以下原因引起的METH药代动力学变化： 抗体剂量METH激发后给出的药物效应问卷将量化IXT-m200的影响 对METH的主观影响。这些数据将用于确定 IXT-m200必要的减少加强主观影响的甲基。此外，在此项目期间，将有 与FDA的互动和整体临床开发计划将通过规划阶段 2b/3在希望使用METH戒烟的较大人群中进行的临床研究。IXT-m200的稳定性测试 制剂将在整个研究期间继续进行，沿着必要的额外生产工作， 支持STAMPOUT研究。 一个经验丰富，跨学科的学术和行业团队将完成以下具体任务 目的：1）通过与FDA的互动和未来规划，推进IXT-m200的临床开发 2）完成STAMPOUT，一项针对甲基苯丙胺门诊治疗的抗体的2a期研究， 和3）执行支持IXT-m200临床研究所需的制造任务。 STAMPOUT是一个转折点。有了概念验证数据，可以制定计划来研究 IXT-m200帮助METH用户戒烟，并将这种改变游戏规则的药物推向市场， 需要的病人。

The US FDA has not approved any medications for the treatment of methamphetamine (METH) use disorders. Currently, cognitive-behavioral and contingency-management interventions are the most effective treatments. IXT-m200, a monoclonal antibody that specifically binds METH in the blood, is being developed as a pharmacological treatment for use in conjunction with behavior therapies. Based on nonclinical studies, IXT-m200 is expected to alter METH pharmacokinetics in human subjects resulting in reduced or blocked METH subjective effects that reinforce METH use. STAMPOUT, a Phase 2a Study of Antibody for Methamphetamine Outpatient Therapy, will provide proof-of-concept that IXT-m200 can alter METH disposition. This is needed before a large efficacy study can be done. This application proposes the first clinical study in METH users of a biological medication developed specifically for patients with METH use disorders. The primary goal of this application is to show that a METH antibody will alter the pharmacokinetics of METH in users and reduce the reinforcing subjective effects that perpetuate METH use. During the STAMPOUT study, METH-using subjects will receive single doses of IXT-m200 followed by weekly METH challenges. Serial blood samples and urine collections will be analyzed to determine the METH pharmacokinetic changes due to the antibody dose. Drug effects questionnaires given after METH challenges will quantify the impact of IXT-m200 on the subjective effects of METH. These data will be used to determine the minimum serum concentration of IXT-m200 necessary for reducing reinforcing subjective effects of METH. Also during this project, there will be interaction with the FDA and the overall clinical development plan will be advanced by planning for a Phase 2b/3 clinical study in larger groups of users who wish to quit using METH. Stability testing of the IXT-m200 drug product will continue throughout the study, along with additional manufacturing work as necessary to support the STAMPOUT study. A highly experienced, transdisciplinary academic and industry team will accomplish the following Specific Aims: 1) Advance the clinical development of IXT-m200 by interacting with FDA and planning for future studies, 2) Complete STAMPOUT, a Phase 2a Study of Antibody for Methamphetamine Outpatient Therapy, and 3) Perform manufacturing tasks required to support a clinical study of IXT-m200. STAMPOUT is a turning point. With proof-of-concept data, plans can be made to study long-term efficacy of IXT-m200 in helping METH users quit and move this game changing medication toward the market and the patients who need it.