NCT00240929

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)

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), A Humanized Respiratory Syncytial Virus Monoclonal Antibody, in Children With a History of Prematurity

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 5 Months – 6 Months
• Healthy volunteers: Not accepted

Summary

A total of 150 children who meet the entry criteria will be randomized 1:1 to receive one of the following treatment sequence A or B.

Detailed description

Phase II, Double-blind, two-period, cross-over study to be conducted at 20 sites the U.S. A total of 150 children who meet the entry criteria will be randomized 1:1 to receive one of the following treatment sequence: Sequence A (single dose of the liquid formulation on Study Day 0 and a single dose of the lyophilized formulation on Study Day 30) or Sequence B (single dose of the lyophized forumation on Study Day 0 and single dose of the liquid formulation on Study Day 30). Children will be followed for adverse events through 30 days after each injection of study drug and will have blood collected for determination of palivizumab concentrations in serum.

Conditions

• -Unhealthy Children With a History of Prematurity

Interventions

Type	Name	Description
DRUG	MEDI-493	Active Comparator

Timeline

• Start date: 2002-09-01
• Completion: 2003-04-01
• First posted: 2005-10-18
• Last updated: 2010-11-15

Locations

1 site across 1 country: United States