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

NCT ID: NCT01353027

Last Updated: 2012-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2011-11-30

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.

Conditions

Ebola Hemorrhagic Fever

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Normal saline

AVI-6002

Phosphorodiamidate morpholino antisense oligomer with positive charges on selected subunits (PMOplus™)

Group Type: EXPERIMENTAL

AVI-6002

Intervention Type: DRUG

Single intravenous administration

Interventions

Placebo

Normal saline

Intervention Type: DRUG

AVI-6002

Single intravenous administration

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Sarepta Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William B Smith, MD

Role: PRINCIPAL_INVESTIGATOR

New Orleans Center for Clinical Research-Knoxville

Alison Heald, MD

Role: STUDY_DIRECTOR

Sarepta Therapeutics, Inc.

Locations

New Orleans Center for Clinical Research - Knoxville

Knoxville, Tennessee, United States

Countries

United States

Other Identifiers

6002-us-101

Identifier Type: -

Identifier Source: org_study_id