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.

Start Date15 Jun 2022

Sponsor / Collaborator

mAbxience Research SL

NCT04540627

/ CompletedPhase 1

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).

Start Date06 Jul 2020

Sponsor / Collaborator

mAbxience Research SL

100 Clinical Results associated with Palivizumab biosimilar(mAbxience Research)

100 Translational Medicine associated with Palivizumab biosimilar(mAbxience Research)

100 Patents (Medical) associated with Palivizumab biosimilar(mAbxience Research)

Literatures (Medical) associated with Palivizumab biosimilar(mAbxience Research)

International Journal of Molecular Sciences

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

Article

Author: 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 Deals associated with Palivizumab biosimilar(mAbxience Research)

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04540627 (CTgov)	Phase 1	-	56	Palivizumab (Open-label Palivizumab (Part 1))	gzapjocflc(ptzofzimbc) = cvrpoycxbh fuuknkdcyt (pmfkvgwrsc, bderziagsp - xmkmwshsig) View more	-	04 Oct 2021
				Placebo (Double-blind Placebo (Part 2))	jjqbafwstr(hacfglejsp) = hjfnujjcjz isnatumdeq (ktrqrixkgj, rqnvgxngfv - jpfjflnrse) View more

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