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Completed

NCT Number: NCT01353027

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

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.

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Key information

Conditions

Ebola Hemorrhagic Fever Filoviridae Infections Hemorrhagic Fever, Ebola Hemorrhagic Fevers, Viral Infections Mononegavirales Infections RNA Virus Infections Virus Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

New Orleans Center for Clinical Research - Knoxville

Knoxville, Tennessee, 37920, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Normal saline

AVI-6002

Drug

Single intravenous administration

Primary outcomes

  1. 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.

Secondary outcomes

  1. Drug concentration in plasma

    Time frame: 28 days

  2. Drug concentration in urine

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Sarepta Therapeutics, Inc.

Industry

Collaborators

  • United States Department of Defense

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 12, 2011
Registry last updated
Mar 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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