A Study to Assess the Safety, Tolerability and Effects of Compound Edaravone Injection (Edaravone + Borneol).
A Randomized, Single-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Edaravone + (+)-Borneol When Administered Intravenously in Healthy Subjects
Medpace Australia Pty Limited
48 participants
Mar 15, 2011
Interventional
Conditions
Summary
Cerebrovascular disease is a disease of the blood vessels supplying the brain. Cerebrovascular disease poses a serious threat and is one of the three leading causes of death in humans. Cerebral stroke (a blockage, or bleed in the brain) leads to a lack of oxygen to the brain. Although there are many drugs used to treat this lack of oxygen resulting from cerebral stroke, these drugs do not work well enough. There is a need for a drug that can treat the injury, which is a result of a lack of oxygen, from cerebrovacsular disease. Edaravone is a drug that can be used to improve the neurological symptoms and dysfunction in daily life caused by a lack of oxygen to the brain tissue from a cerebral stroke. Although Edaravone is currently known to help people who have had a cerebral stroke, the development of a better drug is still needed. Compound Edaravone Injection (study drug) is a combination of Edaravone and a second medication, (+)-borneol. It is believed the combination of these two drugs in specific amounts can further improve the recovery of patients who experience a cerebral stroke. Both Edaravone and (+)-borneol have been used in humans, but not in combination with each other as a single compound. The main purpose of this study is to evaluate the safety and tolerability of single doses of Compound Edaravone Injection (study drug) administered to healthy male and female adults. A second objective is to look at the pharmacokinetics (the study of how much study drug is in your blood at different time periods) of each dose of Compound Edaravone Injection (study drug) in healthy male and female adults.
Eligibility
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Interventions
This is a Single Ascending Dose study. Each subject only receives one dose level once during the study. The cohort is completed and reviewed by a safety review panel before dosing for the next cohort commences. There are 6 cohorts comprised of 8 subjects. The study drug is administered via intravenous injection over 30 minutes and the dosing regieme for each cohort is listed below: Cohort 1: 5 mg Edaravone + 1.25 mg Borneol compound or placebo Cohort 2: 15 mg Edaravone + 3.75 mg Borneol compound or placebo Cohort 3: 30 mg Edaravone + 7.5 mg Borneol compound or placebo Cohort 4: 60 mg Edaravone + 15 mg Borneol compound or placebo Cohort 5: 90 mg Edaravone + 22.5 mg Borneol compound or placebo Cohort 6: 120 mg Edaravone + 30 mg Borneol compound or placebo
Locations(1)
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ACTRN12611000228987