Pharmacokinetic Study Comparing MB05 (Proposed Palivizumab Biosimilar), EU-sourced Synagis® and US-sourced Synagis® in Healthy Volunteers.
Not yet recruiting
mAbxience S.A
Phase 1
2022-01-01
Randomized, double blind, parallel group, single dose, 3 arm study to investigate and compare
the pharmacokinetics (PK), safety, immunogenicity and tolerability of MB05 with US and EU
Synagis® in healthy subjects.
During the course of the study, the similarity in pharmacokinetics will be assessed by
sampling the levels of drug in the blood, and by comparing these levels among the different
administration arms. Safety, tolerability, and immunologic response to the administered drugs
will also be evaluated throughout.
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)
Completed
MedImmune LLC
Phase 2
2002-09-01
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.
Tetracaine Compared to Placebo for Reducing Pain With Palivizumab - A Pilot Study
Completed
Fraser Health
Phase 4
2007-11-01
This is a small study known as a pilot study. This pilot study is being done to see if a
difference in pain from intramuscular palivizumab injection can be detected if tetracaine a
topical numbing gel is used compared to no medication (placebo). If a difference is found in
this pilot study, then a larger study may be done to confirm that there is a difference in
pain experience.
Clinical Study of Palivizumab in Japanese Newborns, Infants and Young Children at the Age of 24 Months or Less With Immunocompromised Medical Conditions
Completed
AbbVie (prior sponsor, Abbott)
Phase 3
2011-08-01
To evaluate safety, efficacy and pharmacokinetics of palivizumab in children at the age of 24
months or less with immunocompromised medical conditions.
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