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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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

Brief 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 Summary:

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.


Sponsor: Sarepta Therapeutics

Current Primary Outcome: Number of participants with adverse events [ Time Frame: 28 Days ]

The frequency and severity of adverse events will be monitored through 28 days post administration.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Drug concentration in plasma [ Time Frame: 28 days ]
  • Drug concentration in urine [ Time Frame: 28 days ]


Original Secondary Outcome: Same as current

Information By: Sarepta Therapeutics

Dates:
Date Received: May 10, 2011
Date Started: May 2010
Date Completion:
Last Updated: March 27, 2012
Last Verified: March 2012