Safety Study of Single Administration Post-Exposure Prophylaxis Treatment for Ebola Virus
- Registration Number
- NCT01353027
- Lead Sponsor
- Sarepta Therapeutics, Inc.
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- Male or female and between the ages of 18 and 50 years in good general health
- Volunteers must be willing to use barrier methods of contraception or be of non-childbearing potential
- Volunteers must be willing to undergo a urine screen for drugs of abuse
- Pregnancy or breastfeeding.
- Any clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology or urinalysis
- Positive test for human immunodeficiency virus, hepatitis B or hepatitis C or known history of HIV infection
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - AVI-6002 AVI-6002 Phosphorodiamidate morpholino antisense oligomer with positive charges on selected subunits (PMOplus™)
- Primary Outcome Measures
Name Time Method Number of participants with adverse events 28 Days The frequency and severity of adverse events will be monitored through 28 days post administration.
- Secondary Outcome Measures
Name Time Method Drug concentration in plasma 28 days Drug concentration in urine 28 days
Trial Locations
- Locations (1)
New Orleans Center for Clinical Research - Knoxville
🇺🇸Knoxville, Tennessee, United States