- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01353040
Safety Study of Single Administration Post-exposure Prophylaxis Treatment for Marburg Virus
May 4, 2012 updated by: Sarepta Therapeutics, Inc.
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Cypress, California, United States, 90630
- West Coast Clinical Trials
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Normal saline
|
Single intravenous administration
|
Experimental: AVI-6003
Phosphorodiamidate morpholino antisense oligomer with positive charges on selected subunits (PMOplus™)
|
Single intravenous administration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of subjects experiencing adverse events
Time Frame: 28 days
|
28 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Plasma drug concentration
Time Frame: 28 days
|
28 days
|
Urine drug concentration
Time Frame: 28 days
|
28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Apinya B Vutikullird, MD, West Coast Clinical Trials
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2011
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
April 22, 2011
First Submitted That Met QC Criteria
May 11, 2011
First Posted (Estimate)
May 12, 2011
Study Record Updates
Last Update Posted (Estimate)
May 7, 2012
Last Update Submitted That Met QC Criteria
May 4, 2012
Last Verified
May 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6003-us-101
- W9113M-10-C-0056 (Other Grant/Funding Number: Transformational Medical Technologies, US Dept. of Defense)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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