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MEDI-493

Phase 2

-Unhealthy Children With a History of Prematurity | Small molecule | Other |AstraZeneca PLC|Last Updated: Nov 15, 2010

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-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment150
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00240929A Phase II Randomized, Double-Blind, Two-Period Cross-Over Study to Evaluate the Pharmacokinetics, Safety and Tolerability of a Liquid Formulation of Palizvizumab (MEDI-493, Synagis)PHASE2 COMPLETED 150Sep 1, 2002Apr 1, 2003Nov 15, 20101 United States
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Study Endpoints
Primary Endpoints
adverse events through 30 days after each injection of study drug and will have blood collected for determination of palivizumab concentrations in serum.
Day 30
Secondary Endpoints
Adverse events and serious adverse events for 30 days after each injection of study drug.
Day 30
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Interventions
NameTypeDescription
MEDI-493DRUGActive Comparator
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Eligibility Criteria
Age Range5 Months — 6 Months
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * The child must have been born at greater than or equal to 35 weeks gestation and be greater than or equal to 6 months of age at the time of randomization (child must be randomized on or before their 6-month birthday) * The child's parent or legal guardian must provide written ...

Countries:United States
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