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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
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01353027Safety Study of Single Administration Post-Exposure Prophylaxis Treatment for Ebola VirusPHASE1 COMPLETED 30May 1, 2010Nov 1, 2011Mar 28, 20121 United States
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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 — 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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