NCT03804476

Phase 1 Study to Assess AER-271

A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Sequential-Group Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of AER-271 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Aeromics, Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The objective of this Phase 1 trial is to assess the safety, tolerability and pharmacokinetics of AER-271 in health subjects.

Detailed description

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.

Conditions

• Stroke
• Stroke, Acute
• Stroke, Ischemic

Interventions

Type	Name	Description
DRUG	AER-271	AER-271, the test article for this study.
DRUG	Placebo	Placebo control for this study.

Timeline

• Start date: 2018-06-26
• Primary completion: 2019-07-18
• Completion: 2019-08-28
• First posted: 2019-01-15
• Last updated: 2020-07-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study