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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sarepta Therapeutics
ClinicalTrials.gov Identifier:
NCT01353027
First received: May 10, 2011
Last updated: March 27, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Ebola Hemorrhagic Fever
Drug: Placebo
Drug: AVI-6002
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Sarepta Therapeutics:

Primary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: 28 Days ] [ Designated as safety issue: Yes ]
    The frequency and severity of adverse events will be monitored through 28 days post administration.


Secondary Outcome Measures:
  • Drug concentration in plasma [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Drug concentration in urine [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: May 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Normal saline
Experimental: AVI-6002
Phosphorodiamidate morpholino antisense oligomer with positive charges on selected subunits (PMOplus™)
Drug: AVI-6002
Single intravenous administration

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01353027

Locations
United States, Tennessee
New Orleans Center for Clinical Research - Knoxville
Knoxville, Tennessee, United States, 37920
Sponsors and Collaborators
Sarepta Therapeutics
Investigators
Principal Investigator: William B Smith, MD New Orleans Center for Clinical Research-Knoxville
Study Director: Alison Heald, MD Sarepta Therapeutics
  More Information

No publications provided

Responsible Party: Sarepta Therapeutics
ClinicalTrials.gov Identifier: NCT01353027     History of Changes
Other Study ID Numbers: 6002-us-101
Study First Received: May 10, 2011
Last Updated: March 27, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
United States: Federal Government

Additional relevant MeSH terms:
Hemorrhagic Fevers, Viral
Hemorrhagic Fever, Ebola
RNA Virus Infections
Virus Diseases
Filoviridae Infections
Mononegavirales Infections

ClinicalTrials.gov processed this record on September 22, 2014