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

Brief Title

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

Official 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

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 Phase

Phase 1

Study Type

Interventional


Primary Outcome

Number of participants with adverse events

Secondary Outcome

 Drug concentration in plasma

Condition

Ebola Hemorrhagic Fever

Intervention

Placebo

Study Arms / Comparison Groups

 Placebo
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

30

Start Date

May 2010

Completion Date

November 2011

Primary Completion Date

November 2011

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - 50 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

William B Smith, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01353027

Organization ID

6002-us-101


Responsible Party

Sponsor

Study Sponsor

Sarepta Therapeutics, Inc.

Collaborators

 United States Department of Defense

Study Sponsor

William B Smith, MD, Principal Investigator, New Orleans Center for Clinical Research-Knoxville


Verification Date

March 2012