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

STAMPOUT：甲基苯丙胺门诊治疗抗体的 2a 期研究

• 批准号: 9458985
• 负责人: W BROOKS GENTRY
• 金额: $ 460.17万
• 依托单位: INTERVEXION THERAPEUTICS, LLC
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-30 至 2020-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9458985
• 关键词: Affinity; Antibodies; Behavior Therapy; Behavioral; Binding; Biological; Blood; Blood Circulation; Blood specimen; Clinical; Clinical Research; Cocaine; Cognitive; Collection; Data; Development Plans; Disease; Dose; Double-Blind Method; Drug Kinetics; Ensure; Freezing; Future; Goals; Grant; Human; Immunotherapy; Industry; Inpatients; Intervention; Ligands; Longitudinal Studies; Measures; Methamphetamine; Methods; Modernization; Monoclonal Antibodies; Mus; National Institute of Drug Abuse; Outcome; Outpatients; Pamphlets; Patients; Pharmaceutical Preparations; Pharmacological Treatment; Pharmacology; Phase; Placebo Control; Preparation; Protocols documentation; Questionnaires; Recovery; Reference Standards; Relapse; Reporting; Research Personnel; Safety; Sampling; Series; Serum; Site; Substance Use Disorder; Toxic effect; Update; Urine; Vaccines; Visit; Work; base; clinical development; clinical practice; cohort; contingency management; disorder later incidence prevention; effective therapy; efficacy study; experience; follow-up; human subject; immunogenicity; improved; methamphetamine effect; methamphetamine use; methamphetamine user; prevent; programs; safety study; stability testing; success

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.

美国FDA尚未批准用于治疗甲基苯丙胺（METH）使用疾病的任何药物。 当前，认知行为和应急管理干预措施是最有效的治疗方法。 IXT-M200是一种特异性结合血液中甲基甲基的单克隆抗体 与行为疗法结合使用的药理治疗。基于非临床研究， IXT-M200有望改变人类受试者中的甲基药代动力学，导致减少或阻塞 甲基主观效应增强了甲基苯丙胺的使用。 Stampout，一项2A阶段的抗体研究 甲基苯丙胺门诊疗法将提供概念验证，即IXT-M200可以改变甲基苯丙胺 性格。在进行大型疗效研究之前，这是需要的。该申请提出了第一个临床 针对专为甲基甲基甲基甲基苯丙胺药物的甲基苯丙胺使用者进行的研究。 该应用的主要目的是表明甲基抗体会改变甲基甲基药物的药代动力学 用户并减少甲基苯丙胺使用的增强主观效果。在Stampout研究中， 使用甲基苯丙胺的受试者将获得单剂量的IXT-M200，然后每周一次的METH挑战。连环血 将分析样品和尿液收集，以确定由于 抗体剂量。药物挑战后给出的药物效应问卷将量化IXT-M200的影响 关于甲基苯丙胺的主观效应。这些数据将用于确定最低血清浓度 IXT-M200需要减少甲基甲基苯丙胺的主观效应所必需的。同样在这个项目中，会有 与FDA的互动以及整体临床开发计划将通过计划一个阶段来提出 在希望使用甲基苯酚戒烟的较大用户中的2B/3临床研究。 IXT-M200的稳定性测试 在整个研究中，药物将继续进行，以及必要的其他制造工作 支持Stampout研究。 一个经验丰富的跨学科学术和行业团队将完成以下特定的 目的：1）通过与FDA互动并计划未来，推进IXT-M200的临床开发 研究，2）完全Stampout，一项2A期抗体甲基苯丙胺门诊疗法的研究， 3）执行支持IXT-M200的临床研究所需的制造任务。 Stampout是一个转折点。借助概念证明数据，可以制定计划研究长期疗效的计划 IXT-M200帮助甲基苯丙胺用户退出并将该游戏更改为市场和 需要它的患者。