Randomized, Double-Blind Study of the Pharmacokinetics and Safety of Palivizumab Liquid Formulation Compared with Lyophilized Formulation.

ABSTRACT:

Objective

To assess the pharmacokinetics and safety of liquid palivizumab compared with lyophilized palivizumab.

Methods

This phase 2, randomized, double-blind crossover study included premature infants aged ≤6 months born ≤35 weeks gestational age. Patients were randomized in a 1:1 ratio to receive a single 15 mg/kg intramuscular dose of liquid (sequence A group) or lyophilized (sequence B group) palivizumab on Day 0. Patients crossed over to receive the alternate formulation on Day 30. Serum palivizumab and antidrug antibody (ADA) levels were measured on Day 0 (predose), Day 30 (before the dose of alternate formulation), and Day 60 (30 days after the dose of alternate formulation). Patients were followed for safety through Day 60 (30 days after the dose of alternate formul

SUBMITTER: Robbie GJ 

PROVIDER: S-EPMC4269619 | biostudies-literature | 2014 Dec

REPOSITORIES: biostudies-literature