FANTASY-A Randomised, Double-Blind, 3-arm Parallel Study to Compare the Pharmacokinetics, Safety, Immunogenicity and Tolerability of MB05 (Proposed Palivizumab Biosimilar), EU-sourced Synagis® and US-sourced Synagis®, Administered as a Single Dose Intramuscular Injection in Healthy Volunteers.

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.

开始日期2022-06-15

申办/合作机构

mAbxience Research SL

NCT04540627

/ Completed临床1期

A Double-Blind, Randomised, Placebo-Controlled Exploratory Study to Estimate the Prophylactic Efficacy of Palivizumab in Healthy Adult Participants Inoculated With Respiratory Syncytial Virus (RSV)

Double-Blind, Randomised, Placebo-Controlled Exploratory Study to Estimate the Prophylactic Efficacy of Palivizumab in Healthy Adult Participants Inoculated with Respiratory Syncytial Virus (RSV).

开始日期2020-07-06

申办/合作机构

mAbxience Research SL

100 项与帕利珠单抗生物类似药(mAbxience Research) 相关的临床结果

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100 项与帕利珠单抗生物类似药(mAbxience Research) 相关的转化医学

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100 项与帕利珠单抗生物类似药(mAbxience Research) 相关的专利（医药）

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项与帕利珠单抗生物类似药(mAbxience Research) 相关的文献（医药）

International Journal of Molecular Sciences

The Interaction and Effect of a Small MitoBlock Library as Inhibitor of ALR Protein–Protein Interaction Pathway

Article

作者: Gallo, Angelo ; Muzzioli, Riccardo

MIA40 and ALR of the MIA pathway mediate the import of protein precursors that form disulfides into the mitochondrial intermembrane space. This import pathway is suggested to be a linear pathway in which MIA40 first binds to the precursor via a disulfide linkage and oxidizes it. Subsequently, ALR re-oxidizes MIA40 and then ALR transfers electrons to terminal electron acceptors. However, the precise mechanism by which ALR and MIA40 coordinate translocation is unknown. With a collection of small molecule modulators (MB-5 to MB-9 and MB-13) that inhibit ALR activity, we characterized the import mechanism in mitochondria. NMR studies show that most of the compounds bind to a similar region in ALR. Mechanistic studies with small molecules demonstrate that treatment with compound MB-6 locks the precursor in a state bound to MIA40, blocking re-oxidation of MIA40 by ALR. Thus, small molecules that target a similar region in ALR alter the dynamics of the MIA import pathway differently, resulting in a set of probes that are useful for studying the catalysis of the redox-regulated import pathway in model systems.

100 项与帕利珠单抗生物类似药(mAbxience Research) 相关的药物交易

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04540627 (CTgov)	临床1期	-	56	Palivizumab (Open-label Palivizumab (Part 1))	網衊艱製醖遞範選夢鹽(遞憲淵鏇鑰壓積糧鏇鹽) = 壓鑰餘餘窪膚選衊繭遞膚襯艱艱觸製憲範願鏇 (範鑰餘夢餘製鏇遞簾選, 膚淵鹹繭窪艱壓廠選壓 ~ 鹽襯壓襯網淵夢膚鹽製) 更多	-	2021-10-04
				Placebo (Double-blind Placebo (Part 2))	繭餘積簾壓廠觸鏇鬱構(艱淵窪鏇鏇鹽壓艱鹽衊) = 鹽築衊範憲鑰襯壓觸憲襯膚夢襯艱選窪積選選 (窪積壓選衊餘網襯構壓, 醖簾壓繭餘糧築鏇夢餘 ~ 淵網繭積壓夢夢願選糧) 更多