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Last Updated: March 28, 2024

CLINICAL TRIALS PROFILE FOR SYNAGIS


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Biosimilar Clinical Trials for SYNAGIS

This table shows clinical trials for biosimilars. See the next table for all clinical trials
Trial ID Title Status Sponsor Phase Start Date Summary
NCT05121246 ↗ 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.
>Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for SYNAGIS

Trial ID Title Status Sponsor Phase Start Date Summary
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) 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.
NCT00484393 ↗ 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.
NCT01466062 ↗ 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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for SYNAGIS

Condition Name

Condition Name for SYNAGIS
Intervention Trials
Respiratory Syncytial Virus (RSV) 1
Respiratory Syncytial Virus Infection 1
RSV Infection 1
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Condition MeSH

Condition MeSH for SYNAGIS
Intervention Trials
Virus Diseases 2
Respiratory Syncytial Virus Infections 2
Premature Birth 1
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Clinical Trial Locations for SYNAGIS

Trials by Country

Trials by Country for SYNAGIS
Location Trials
United States 11
Japan 2
Belarus 1
Poland 1
Ukraine 1
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Trials by US State

Trials by US State for SYNAGIS
Location Trials
Texas 2
California 2
Illinois 1
Florida 1
Washington 1
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Clinical Trial Progress for SYNAGIS

Clinical Trial Phase

Clinical Trial Phase for SYNAGIS
Clinical Trial Phase Trials
Phase 4 1
Phase 3 2
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for SYNAGIS
Clinical Trial Phase Trials
Completed 5
Recruiting 1
Not yet recruiting 1
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Clinical Trial Sponsors for SYNAGIS

Sponsor Name

Sponsor Name for SYNAGIS
Sponsor Trials
MedImmune LLC 2
Fraser Health 1
AbbVie (prior sponsor, Abbott) 1
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Sponsor Type

Sponsor Type for SYNAGIS
Sponsor Trials
Industry 7
Other 3
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