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

临床试验：在 HE 中使用 DAS181 进行单剂量递增 IA 期临床研究

• 批准号: 7951500
• 负责人: BIRGIT WINTHER
• 金额: $ 6.92万
• 依托单位: UNIVERSITY OF VIRGINIA
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-03-01 至 2010-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7951500
• 关键词: Adult; Adverse event; Breathing; Clinical Research; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Data; Dose; Double-Blind Method; Drug Kinetics; Funding; Future; Grant; Influenza; Inhalators; Institution; Oral; Pharmaceutical Preparations; Phase; Phase I Clinical Trials; Placebos; Powder dose form; Randomized; Research; Research Personnel; Resources; Safety; Source; United States National Institutes of Health; base; design; immunogenicity; meetings

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.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目和 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 当使用干粉吸入器通过口服吸入给药时，DAS181 旨在治疗自然获得的流感。 。这是一项在健康成人中使用 DAS181 单剂量治疗的随机、双盲、剂量递增的 1 期研究。 受试者将以 2:1 的比例随机分配接受 DAS181 或安慰剂的单剂量治疗。该研究旨在综合不良事件发生率、免疫原性特征和药代动力学特征，探讨 DAS181 单剂量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。 该研究将以剂量递增步骤进行，从最低剂量水平开始，在满足剂量递增标准后转向更高剂量水平。 在每个剂量组中，研究药物给药将以交错的步骤开始。 给药后将对受试者进行 30 天的跟踪。