Clinical Trial: Safety Study of Single Administration Post-exposure Prophylaxis Treatment for Marburg Virus
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose-Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of AVI-6003 in Healthy Adult Volunteers
Brief Summary: The purpose of this study is to characterize the safety and pharmacology of single administrations of AVI-6003, a post-exposure prophylaxis candidate treatment for Marburg virus.
Detailed Summary: Marburg hemorrhagic fever is a rare human disease caused by the Marburg virus, a filamentous, single-stranded, negative-sense RNA virus. In general, the mortality rate associated with Marburg virus outbreaks has ranged from 23% to 88%, with the highest death rates seen in more recent epidemics. No vaccine or effective therapy is available for Marburg hemorrhagic fever. AVI-6003 is an experimental combination of 2 phosphorodiamidate morpholino antisense oligomers with positive charges on selected subunits (PMOplus™). These oligomers specifically target viral messenger RNA encoding 2 Marburg virus proteins thought to be important in viral replication and host immune suppression. The present study is designed to characterize the safety, tolerability and pharmacokinetics of escalating single-administration doses of AVI-6003 in healthy human subjects.
Sponsor: Sarepta Therapeutics
Current Primary Outcome: Number of subjects experiencing adverse events [ Time Frame: 28 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Plasma drug concentration [ Time Frame: 28 days ]
- Urine drug concentration [ Time Frame: 28 days ]
Original Secondary Outcome: Same as current
Information By: Sarepta Therapeutics
Dates:
Date Received: April 22, 2011
Date Started: May 2011
Date Completion:
Last Updated: May 4, 2012
Last Verified: May 2012
