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: 7718593
• 负责人: BIRGIT WINTHER
• 金额: $ 9.13万
• 依托单位: UNIVERSITY OF VIRGINIA
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-03-01 至 2009-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7718593
• 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; Rate; Research; Research Personnel; Resources; Safety; Source; United States National Institutes of Health; base; day; design; immunogenicity

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. DAS181 is intended to treat naturally acquired influenza. When administered by oral inhalation using a dry powder inhaler. 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.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 DAS 181预期用于治疗自然获得性流感。当使用干粉吸入器经口吸入给药时。这是一项在健康成人中进行的DAS 181单次给药治疗的随机化、双盲、剂量递增I期研究。 受试者将以2：1的比例随机接受DAS 181或安慰剂单次给药治疗。本研究旨在根据不良事件发生率、免疫原性特征和药代动力学特征的组合，探索DAS 181单次给药治疗的安全性和耐受性。 本研究的数据将用于选择未来研究的剂量水平。 本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移至较高剂量水平。 在每个剂量组内，研究药物给药将以交错的步骤开始。 受试者将在给药后随访30天。