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. AER-271 is an Aquaporin-4 inhibitor designed to prevent brain swelling in severe ischemic stroke. The study will be conducted in 2 parts: Part A is a single ascending dose, sequential group study. The subsequent Part B is a multiple ascending dose, sequential group study. Both Parts A and B will follow an adaptive design including the use of Sentinel Dosing.~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. 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. 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. Data from this trial will also be used to develop a protocol for a subsequent Phase 2 clinical trial in stroke patients.
The objective of this Phase 1 trial is to assess the safety, tolerability and pharmacokinetics of AER-271 in health subjects.