CLINICAL TRIAL: SINGLE DOSE ESCALATING PHASE IA CLINICAL STUDY WITH DAS181 IN HE

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。 当使用干粉吸入器口服吸入时，DAS181用于治疗自然获得性流感。。这是一项随机、双盲、剂量递增的第一阶段研究，在健康成年人中使用DAS181进行单次剂量治疗。受试者将以2：1的比例随机接受DAS181或安慰剂的单剂量治疗。这项研究旨在结合不良事件发生率、免疫原性和药代动力学特征，探索DAS181单剂治疗的安全性和耐受性。这项研究的数据将用于选择未来研究的剂量水平。这项研究将以剂量递增的步骤进行，从最低剂量水平开始，在满足剂量递增标准后转移到更高的剂量水平。在每个剂量组内，研究药物剂量将以交错步骤开始。受试者在服药后将被跟踪30天。

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. When administered by oral inhalation using a dry powder inhaler DAS181 is intended to treat naturally acquired influenza. . This is a randomized, double-blinded, dose escalating Phase 1 study of a single dose treatment with DAS181 in healthy adults. Subjects will be randomized in a 2:1 ratio to receive either a single dose treatment with DAS181 or placebo. The study is designed to explore the safety and tolerability of a single dose treatment with DAS181, based on a combination of the adverse event rates, immunogenicity profile and pharmacokinetic profile. The data from this study will be used to select the dose levels for future studies. The study will be conducted in dose escalating steps, which will start from the lowest dose level and move to the higher dose levels after dose escalating criteria are met. Within each dose group, study drug dosing will be initiated in staggered steps. The subjects will be followed for 30 days after dosing.