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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

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment150

FDA Designations

No designations recorded

Clinical trial landscape

MEDI-493 · 1 trial · 1 indication

Phase 2 1
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)-Unhealthy Children With a History of Prematurity
COMPLETED150 Analytics
PHASE2COMPLETED
A 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)
-Unhealthy Children With a History of PrematurityUnlock trial analytics

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 to 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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Frequently asked questions about MEDI-493

What is MEDI-493 used for?

MEDI-493 is an investigational small molecule being studied for use in unhealthy children with a history of prematurity. It is currently in Phase 2 clinical development and is not approved by the FDA. The drug is being developed by AstraZeneca PLC.

What does MEDI-493 target?

MEDI-493 is a small molecule, but its specific molecular target has not been disclosed in the available information. The drug is being studied for its pharmacokinetics, safety, and tolerability in a pediatric population with a history of prematurity.

Who makes MEDI-493?

MEDI-493 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The drug is currently in Phase 2 clinical development for use in unhealthy children with a history of prematurity.

What phase is MEDI-493 in?

MEDI-493 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. One clinical trial has been completed, and the drug is not currently in any active trials.

What clinical trials is MEDI-493 in?

MEDI-493 has one completed clinical trial, NCT00240929, a Phase II randomized, double-blind, two-period cross-over study. The trial evaluated the pharmacokinetics, safety, and tolerability of a liquid formulation of the drug in 150 unhealthy children with a history of prematurity in the United States.

Is MEDI-493 the same as Synagis?

MEDI-493 is also known as palivizumab and is referred to as Synagis in the clinical trial title. The trial NCT00240929 evaluates a liquid formulation of palivizumab (MEDI-493, Synagis), indicating that MEDI-493 and Synagis are the same drug.