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

Marburg Hemorrhagic Fever Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01353040
• Other study ID #: 6003-us-101
• Secondary ID: W9113M-10-C-0056
• Status: Completed
• Phase: Phase 1
• First received: April 22, 2011
• Last updated: May 4, 2012
• Start date: May 2011
• Est. completion date: December 2011

Study information

• Verified date: May 2012
• Source: Sarepta Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Marburg Hemorrhagic Fever
• Marburg Virus Disease

Intervention

Drug:
• AVI-6003
Single intravenous administration
• Placebo
Single intravenous administration

Locations

Country	Name	City	State
United States	West Coast Clinical Trials	Cypress	California

Sponsors (2)

Lead Sponsor	Collaborator
Sarepta Therapeutics	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects experiencing adverse events		28 days	No
Secondary	Plasma drug concentration		28 days	No
Secondary	Urine drug concentration		28 days	No