MULTI-DOSE PLACEBO-CONTROLLED PHASE I STUDY OF AEOL 10150 IN PATIENTS WITH ALS

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 肌萎缩侧索硬化症(ALS)是一种毁灭性的神经系统疾病，目前尚无确切的诊断方法。AEOL 10150是一种锰卟啉抗氧化剂，可以破坏可能与肌萎缩侧索硬化症有关的活性氧物种。这项研究将确定AEOL 10150(40、70和100 mg SC，6天，然后qd，第7天)与安慰剂治疗ALS患者的安全性、耐受性和药代动力学特征，并帮助确定有效性试验的最大耐受量。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Amyotrophic Lateral Sclerosis (ALS) is a devastating neurological disease without a known sure. AEOL 10150 is a manganoporphrin antioxidant that destroys reactive-oxygen species potentially implicated in ALS. This study will determine the safety, tolerability, and pharmacokinetic profile of AEOL 10150 (at 40, 70, and 100 mg SC for six days, then qd for day seven) compared with placebo in patients with ALS and help determine the maximum tolerated dose for an efficacy trial.