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

Phase 1

Completed

• Conditions: Ebola Hemorrhagic Fever
• Interventions: Drug: Placebo; Drug: AVI-6002

• 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.

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2011-05-10
• Study First Submitted QC: 2011-05-11
• Study First Posted: 2011-05-12
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-27
• Last Update Posted: 2012-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

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