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

Ebola Hemorrhagic Fever Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01353027
• Other study ID #: 6002-us-101
• Status: Completed
• Phase: Phase 1
• First received: May 10, 2011
• Last updated: March 27, 2012
• Start date: May 2010
• Est. completion date: November 2011

Study information

• Verified date: March 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-6002, a post-exposure prophylaxis candidate treatment for Ebolavirus.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2011
• Est. primary completion date: November 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

• Ebola Hemorrhagic Fever
• Hemorrhagic Fever, Ebola

Intervention

Drug:
• Placebo
Normal saline
• AVI-6002
Single intravenous administration

Locations

Country	Name	City	State
United States	New Orleans Center for Clinical Research - Knoxville	Knoxville	Tennessee

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 participants with adverse events	The frequency and severity of adverse events will be monitored through 28 days post administration.	28 Days	Yes
Secondary	Drug concentration in plasma		28 days	No
Secondary	Drug concentration in urine		28 days	No