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AVI-6002

Phase 1

Ebola Hemorrhagic Fever | Small molecule | Infectious Disease |Sarepta Therapeutics, Inc.|Last Updated: Mar 28, 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-6002 · 1 trial · 1 indication

Phase 1 1
NCT01353027Safety Study of Single Administration Post-Exposure Prophylaxis Treatment for Ebola VirusEbola Hemorrhagic Fever
COMPLETED30 Analytics
PHASE1COMPLETED
Safety Study of Single Administration Post-Exposure Prophylaxis Treatment for Ebola Virus
Ebola Hemorrhagic FeverUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants with adverse events
28 Days

The frequency and severity of adverse events will be monitored through 28 days post administration.

Secondary Endpoints

Drug concentration in plasma
28 days
Drug concentration in urine
28 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATOR -
AVI-6002EXPERIMENTALPhosphorodiamidate morpholino antisense oligomer with positive charges on selected subunits (PMOplus™)

Interventions

NameTypeDescription
PlaceboDRUGNormal saline
AVI-6002DRUGSingle 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-6002

What is AVI-6002 used for?

AVI-6002 is an investigational small molecule being developed for the prevention of Ebola Hemorrhagic Fever. It is designed as a post-exposure prophylaxis treatment for Ebola virus infection. The drug is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who makes AVI-6002?

AVI-6002 is being developed by Sarepta Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol SRPT. The company is conducting clinical trials to evaluate the safety of this investigational drug for Ebola Hemorrhagic Fever.

What phase is AVI-6002 in?

AVI-6002 is in Phase 1 clinical development. A Phase 1 clinical trial has been completed to evaluate the safety of the drug. It is an investigational product and has not received FDA approval. The drug is being studied as a post-exposure prophylaxis treatment for Ebola virus.

What clinical trials is AVI-6002 in?

AVI-6002 has been studied in one clinical trial, identified as NCT01353027. This was a Phase 1, randomized, double-blind, placebo-controlled study titled 'Safety Study of Single Administration Post-Exposure Prophylaxis Treatment for Ebola Virus'. The trial was completed in the United States and enrolled 30 healthy volunteers aged 18 years and older.

Is AVI-6002 the same as other Ebola treatments?

AVI-6002 is a distinct investigational drug developed by Sarepta Therapeutics. It is a small molecule designed for post-exposure prophylaxis of Ebola virus infection. No alternative names for AVI-6002 have been disclosed, and it is not the same as other approved or investigational Ebola treatments.