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Safety Study of Single Administration Post-exposure Prophylaxis Treatment for Marburg Virus

This study has been completed.
Sponsor:
Collaborator:
Department of Defense
Information provided by (Responsible Party):
Sarepta Therapeutics
ClinicalTrials.gov Identifier:
NCT01353040
First received: April 22, 2011
Last updated: May 4, 2012
Last verified: May 2012
History of Changes
  Purpose

The purpose of this study is to characterize the safety and pharmacology of single administrations of AVI-6003, a post-exposure prophylaxis candidate treatment for Marburg virus.


Condition Intervention Phase
Marburg Hemorrhagic Fever
 Drug: AVI-6003
Drug: Placebo
 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 Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose-Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of AVI-6003 in Healthy Adult Volunteers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sarepta Therapeutics:

Primary Outcome Measures:
  • Number of subjects experiencing adverse events [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma drug concentration [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Urine drug concentration [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: May 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AVI-6003
Phosphorodiamidate morpholino antisense oligomer with positive charges on selected subunits (PMOplus™)
 Drug: AVI-6003
Single intravenous administration
Placebo Comparator: Placebo
Normal saline
 Drug: Placebo
Single intravenous administration

Detailed Description:

Marburg hemorrhagic fever is a rare human disease caused by the Marburg virus, a filamentous, single-stranded, negative-sense RNA virus. In general, the mortality rate associated with Marburg virus outbreaks has ranged from 23% to 88%, with the highest death rates seen in more recent epidemics. No vaccine or effective therapy is available for Marburg hemorrhagic fever. AVI-6003 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 Marburg virus 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-6003 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01353040

Locations
United States, California
West Coast Clinical Trials
Cypress, California, United States, 90630
Sponsors and Collaborators
Sarepta Therapeutics
Department of Defense
Investigators
Study Director: Alison Heald, MD Sarepta Therapeutics
Principal Investigator: Apinya B Vutikullird, MD West Coast Clinical Trials
  More Information

No publications provided

Responsible Party: Sarepta Therapeutics
ClinicalTrials.gov Identifier: NCT01353040     History of Changes
Other Study ID Numbers: 6003-us-101, W9113M-10-C-0056
Study First Received: April 22, 2011
Last Updated: May 4, 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
Marburg Virus Disease
RNA Virus Infections
 Virus Diseases
Filoviridae Infections
Mononegavirales Infections

ClinicalTrials.gov processed this record on May 23, 2013