10/19/2023 0 Comments Aer meaning medical![]() ![]() Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) The planned study design may be modified in accordance with the adaptive features of the clinical study protocol. Additional cohorts may be enrolled to explore additional dose levels. Part A will have 6 cohorts and Part B will have 3. The remaining 6 subjects in a cohort will be randomized 4:2 AER-271:placebo and administered study drug after the SMB has reviewed the first 24 hours of safety data for the first 4 subjects. Part B sentinel dosing will randomize the first 4 subjects 2:2 AER-271:placebo. The remaining 6 subjects in a cohort will be randomized 5:1 AER-271:placebo and administered drug after the Safety Monitoring Board (SMB) has reviewed the first 24 hours of safety data for the first 2 subjects. Part A sentinel dosing will randomize the first 2 subjects 1:1 AER-271:placebo. Both Parts A and B will comprise an adaptive design. ![]() Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More InformationĪ double-blind, randomized, placebo-controlled, sequential-group, single and multiple intravenous dose escalation study conducted in 2 parts. Data from this trial will also be used to develop a protocol for a subsequent Phase 2 clinical trial in stroke patients. An additional exploratory objective of this study is to evaluate the effects of AER-271 on electrocardiogram parameters including QT interval corrected for heart rate. Secondary objectives include: determining the pharmacokinetics of AER-271 and AER-270 following administration of AER-271, determining the dose proportionality for AER-270 and 271, and comparing the effects of continuous infusion versus multiple bolus doses on AER-271 exposure and adverse events. The primary objectives of this study are to assess the safety and tolerability of single and multiple IV doses and continuous infusion of AER-271 in healthy subjects. Both Parts A and B will follow an adaptive design including the use of Sentinel Dosing. The subsequent Part B is a multiple ascending dose, sequential group study. The study will be conducted in 2 parts: Part A is a single ascending dose, sequential group study. AER-271 is an Aquaporin-4 inhibitor designed to prevent brain swelling in severe ischemic stroke. This is a double-blind, randomized, placebo-controlled, sequential-group study to assess the safety, tolerability and pharmacokinetics of single ascending dose and multiple ascending doses of intravenously (IV) administered AER-271 in healthy human subjects. Why Should I Register and Submit Results?. ![]()
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