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AVI-4020

Phase 1

West Nile Virus | Small molecule | Other |Sarepta Therapeutics, Inc.|Last Updated: Jul 8, 2009

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment14
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00387283Pharmacokinetic Study in Cerebral Spinal Fluid After a Single Dose of AVI-4020PHASE1 COMPLETED 14Oct 1, 2006Jun 1, 2009Jul 8, 20091 United States
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Study Endpoints
Primary Endpoints
To determine if the study drug penetrates the blood brain barrier following a single dose of AVI-4020, and if it does, the associated CSF, plasma and urine pharmacokinetics
Secondary Endpoints
Safety, Tolerability
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
AVI-4020 InjectionDRUG -
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Eligibility Criteria
Age Range18 Years — 64 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Adult males 18 years to 64 years of age; * Good general health (as evidenced by no chronic conditions, normal physical exam, vital signs within normal limits; laboratory evaluations within normal range) * Signed and dated written informed consent form; and * Willing to partici...

Countries:United States
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