Phase I Rising-dose Study to Assess Tolerability, Safety, Pharmacokinetics, Pharmacodynamics of AR09

Anesthesia Clinical Trial

Official title: A Phase I, Randomized, Double-blind, Placebo-controlled, Rising-dose Study to Assess the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics of Single IV Doses of AR09 in Healthy Subjects

Status Terminated

Clinical Trial Summary

This will be a randomized, double-blind, placebo-controlled, rising-dose study of single IV doses of AR09 in healthy subjects. Each infusion will occur over 10 minutes.

Clinical Trial Description

Each subject will complete Screening, Baseline, Treatment, and Follow-Up Phases. The Screening Phase will be conducted on an outpatient basis within 30 days, but no less than 3 days, prior to the start of the Baseline Phase. The Baseline Phase will consist of clinical research unit (CRU) admission and final qualification assessments. The Treatment Phase will be comprised of dosing on Day 1, post-treatment safety and pharmacodynamic assessments, and blood and urine collection. Subjects may be discharged approximately 24 hours after study drug administration on Day 2, provided the Modified Aldrete Score and all designated discharge criteria are clinically acceptable to the Investigator. The Follow-Up Phase will occur on Study Day 5 (± 1 day). ;

Related Conditions & MeSH terms

• Anesthesia

• NCT number: NCT02027155
• Study type: Interventional
• Source: Arbor Pharmaceuticals, Inc.
• Status: Terminated
• Phase: Phase 1
• Start date: December 2013
• Completion date: April 2014