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: 9762072
• 负责人: W BROOKS GENTRY
• 金额: $ 93.89万
• 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 2022-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9762072
• 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; Placebos; 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措施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，正在开发中 药物治疗与行为疗法结合使用。基于非临床研究， IXT-m200 有望改变人类受试者中的 METH 药代动力学，从而减少或阻断 加强冰毒使用的冰毒主观效应。 STAMPOUT，一项 2a 期抗体研究 甲基苯丙胺门诊治疗将提供 IXT-m200 可以改变甲基苯丙胺的概念验证 处置。在进行大规模功效研究之前需要这样做。该申请提出了第一个临床 对冰毒使用者进行的一项研究，专门针对冰毒使用障碍患者开发了一种生物药物。 本申请的主要目标是证明 METH 抗体会改变 METH 在体内的药代动力学 用户并减少使 METH 使用永久化的强化主观效应。在 STAMPOUT 研究期间， 使用 METH 的受试者将接受单剂 IXT-m200，然后每周接受 METH 挑战。连续血 将分析样本和尿液收集以确定由于 METH 引起的药代动力学变化 抗体剂量。 METH 挑战后提供的药物影响调查问卷将量化 IXT-m200 的影响 METH 的主观影响。这些数据将用于确定最低血清浓度 IXT-m200 对于减少 METH 的强化主观效应是必需的。此外，在这个项目期间，还将有 与 FDA 的互动和总体临床开发计划将通过规划一个阶段来推进 针对希望戒除冰毒的较大群体的 2b/3 临床研究。 IXT-m200 的稳定性测试 药品将在整个研究过程中继续进行，并根据需要进行额外的生产工作 支持 STAMPOUT 研究。 经验丰富的跨学科学术和行业团队将完成以下具体任务 目标：1）通过与 FDA 互动并规划未来，推进 IXT-m200 的临床开发 研究，2) 完整的 STAMPOUT，甲基苯丙胺门诊治疗抗体的 2a 期研究， 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。通过概念验证数据，可以制定计划来研究长期疗效 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和 有需要的患者。