NCT01353027

Safety Study of Single Administration Post-Exposure Prophylaxis Treatment for Ebola Virus

A Phase I Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose-Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of AVI-6002 in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Sarepta Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to characterize the safety and pharmacology of single administrations of AVI-6002, a post-exposure prophylaxis candidate treatment for Ebolavirus.

Detailed description

Ebola hemorrhagic fever (EHF) is a rare human disease caused by Ebola Virus (EBOV), a filamentous single-stranded, negative-sense RNA virus. Since 1976 several Ebolavirus outbreaks have occurred with fatality rates ranging from 57% to 90%, with most of these outbreaks traced to single EBOV species; EBOV-Z. No effective therapy is currently available for Ebolavirus. AVI-6002 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 Ebolavirus 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-6002 in healthy human subjects.

Conditions

• Ebola Hemorrhagic Fever

Interventions

Type	Name	Description
DRUG	Placebo	Normal saline
DRUG	AVI-6002	Single intravenous administration

Timeline

• Start date: 2010-05-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2011-05-12
• Last updated: 2012-03-28

Locations

1 site across 1 country: United States