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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Ebola Hemorrhagic Fever

Intervention / Treatment
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* Drug: Placebo
* Drug: AVI-6002


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Normal saline<br>|
| Experimental: AVI-6002<br>Phosphorodiamidate morpholino antisense oligomer with positive charges on selected subunits (PMOplus™) | Drug: AVI-6002<br>* Single intravenous administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug concentration in plasma |  | 28 days | 
| Drug concentration in urine |  | 28 days |