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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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.
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 (PMOplusâ„¢). 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| AVI-6002 | Experimental | Phosphorodiamidate morpholino antisense oligomer with positive charges on selected subunits (PMOplusâ„¢) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Normal saline |
| |
| AVI-6002 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | The frequency and severity of adverse events will be monitored through 28 days post administration. | 28 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Drug concentration in plasma | 28 days | |
| Drug concentration in urine | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William B Smith, MD | New Orleans Center for Clinical Research-Knoxville | Principal Investigator |
| Alison Heald, MD | Sarepta Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Orleans Center for Clinical Research - Knoxville | Knoxville | Tennessee | 37920 | United States |
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| ID | Term |
|---|---|
| D019142 | Hemorrhagic Fever, Ebola |
| ID | Term |
|---|---|
| D006482 | Hemorrhagic Fevers, Viral |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| Drug |
Single intravenous administration |
|
| D018702 |
| Filoviridae Infections |
| D018701 | Mononegavirales Infections |