Safety Study of Single Administration Post-Exposure Prophylaxis Treatment for Ebola Virus
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|ClinicalTrials.gov Identifier: NCT01353027|
Recruitment Status : Completed
First Posted : May 12, 2011
Last Update Posted : March 28, 2012
|Condition or disease||Intervention/treatment||Phase|
|Ebola Hemorrhagic Fever||Drug: Placebo Drug: AVI-6002||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||November 2011|
|Actual Study Completion Date :||November 2011|
|Placebo Comparator: Placebo||
Phosphorodiamidate morpholino antisense oligomer with positive charges on selected subunits (PMOplus™)
Single intravenous administration
- 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.
- Drug concentration in plasma [ Time Frame: 28 days ]
- Drug concentration in urine [ Time Frame: 28 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|