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AVI-6003

Phase 1

Marburg Hemorrhagic Fever | Small molecule | Infectious Disease |Sarepta Therapeutics, Inc.|Last Updated: May 7, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

AVI-6003 · 1 trial · 1 indication

Phase 1 1
NCT01353040Safety Study of Single Administration Post-exposure Prophylaxis Treatment for Marburg VirusMarburg Hemorrhagic Fever
COMPLETED30 Analytics
PHASE1COMPLETED
Safety Study of Single Administration Post-exposure Prophylaxis Treatment for Marburg Virus
Marburg Hemorrhagic FeverUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of subjects experiencing adverse events
28 days

Secondary Endpoints

Plasma drug concentration
28 days
Urine drug concentration
28 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AVI-6003EXPERIMENTALPhosphorodiamidate morpholino antisense oligomer with positive charges on selected subunits (PMOplus™)
PlaceboPLACEBO_COMPARATORNormal saline

Interventions

NameTypeDescription
AVI-6003DRUGSingle intravenous administration
PlaceboDRUGSingle intravenous administration
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

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:...

Countries:United States
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Frequently asked questions about AVI-6003

What is AVI-6003 used for?

AVI-6003 is an investigational small molecule being developed for Marburg Hemorrhagic Fever, a severe infectious disease. It is intended as a post-exposure prophylaxis treatment for Marburg virus infection. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes AVI-6003?

AVI-6003 is being developed by Sarepta Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol SRPT. The company is conducting clinical research on this investigational drug for the treatment of Marburg Hemorrhagic Fever.

What phase is AVI-6003 in?

AVI-6003 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The drug is being studied for safety and tolerability in healthy volunteers as a potential post-exposure prophylaxis for Marburg virus infection.

What clinical trials is AVI-6003 in?

AVI-6003 has one completed Phase 1 clinical trial, identified as NCT01353040, titled 'Safety Study of Single Administration Post-exposure Prophylaxis Treatment for Marburg Virus.' This randomized, double-blind, placebo-controlled study enrolled 30 healthy adult volunteers in the United States and evaluated the safety of the drug.

How does AVI-6003 work?

AVI-6003 is a small molecule therapeutic being developed as a post-exposure prophylaxis for Marburg virus infection. The specific molecular target of AVI-6003 has not been disclosed in available clinical trial information, so its precise mechanism of action is not publicly detailed.