Safety Study of Single Administration Post-Exposure Prophylaxis Treatment for Ebola Virus
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
- Number of participants with adverse events [ Time Frame: 28 Days ] [ Designated as safety issue: Yes ]The frequency and severity of adverse events will be monitored through 28 days post administration.
- Drug concentration in plasma [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- Drug concentration in urine [ Time Frame: 28 days ] [ Designated as safety issue: No ]
|Study Start Date:||May 2010|
|Study Completion Date:||November 2011|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
|Placebo Comparator: Placebo||
Phosphorodiamidate morpholino antisense oligomer with positive charges on selected subunits (PMOplus™)
Single intravenous administration
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01353027
|United States, Tennessee|
|New Orleans Center for Clinical Research - Knoxville|
|Knoxville, Tennessee, United States, 37920|
|Principal Investigator:||William B Smith, MD||New Orleans Center for Clinical Research-Knoxville|
|Study Director:||Alison Heald, MD||Sarepta Therapeutics|