CLINICAL TRIALS PROFILE FOR SYNAGIS
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Biosimilar Clinical Trials for SYNAGIS
| 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 | >Sponsor | >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. |
| NCT02544984 ↗ | The Anti-inflammatory Effect of Prophylactic Macrolides on Children With Chronic Lung Disease | Completed | The University of Texas Health Science Center, Houston | N/A | 2015-10-01 | The purpose of this study is to determine if the prophylactic use of azithromycin will reduce the total number of days when unscheduled treatment is given outside of the home in a clinic, urgent care, emergency room or hospital setting between the respiratory illness season months (October 1-March 31) and subsequent 2 month follow-up (April and May) |
| NCT02968173 ↗ | A Study to Assess the Safety and Effectiveness of Palivizumab Administered to Children at High Risk of Severe Respiratory Syncytial Virus (RSV) Infection in the Russian Federation and the Republic of Belarus | Completed | AbbVie | Phase 3 | 2016-11-09 | This is a Phase 3b, prospective, multicenter, open-label, non-controlled study to assess the safety and effectiveness of immunoprophylaxis with the intramuscular (IM) administration of the liquid formulation of palivizumab for the prevention of RSV hospitalizations in infants at high risk (infants born at less than or equal to 35 weeks gestational age and less than or equal to 6 months of age at enrollment; or infants less than or equal to 24 months of age with a diagnosis of chronic lung disease [CLD] of prematurity requiring on-going medical treatment within the previous 6 months or infants less than or equal to 24 months of age with hemodynamically significant congenital heart disease [CHD]). |
| NCT04484935 ↗ | Evaluate the Safety and Tolerability, for Nirsevimab in Immunocompromised Children | Recruiting | Iqvia Pty Ltd | Phase 2 | 2020-08-19 | Study D5290C00008 is a Phase 2, open-label, uncontrolled, single-dose study to evaluate the safety and tolerability, PK, occurrence of ADA, and efficacy of nirsevimab in immunocompromised children who are ≤ 24 months of age at the time of dose administration. Approximately 100 subjects will be enrolled. Subjects will be followed for approximately 1 year after dose administration. |
| NCT04484935 ↗ | Evaluate the Safety and Tolerability, for Nirsevimab in Immunocompromised Children | Recruiting | IQVIA Services Japan K.K. | Phase 2 | 2020-08-19 | Study D5290C00008 is a Phase 2, open-label, uncontrolled, single-dose study to evaluate the safety and tolerability, PK, occurrence of ADA, and efficacy of nirsevimab in immunocompromised children who are ≤ 24 months of age at the time of dose administration. Approximately 100 subjects will be enrolled. Subjects will be followed for approximately 1 year after dose administration. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
Clinical Trial Conditions for SYNAGIS
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