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PK Bioequivalence Single-dose Safety Tolerability Study in Healthy Male Volunteers to Compare CBT124 & Avastin(EU&US)

ABSTRACT: This study aims to investigate the bioequivalence of new formulation of bevacizumab called CBT124 and safety when compared to two already marketed formulations, one approved in US and other in EU of Avastin(Registered Trademark). Adult healthy male aged 18 to 50 years (both inclusive) can participate in this trial. Participants will be randomised (allocated by chance) to either a test formulation or one of the two marketed formulations of bevacizumab. Drugs will be administered intravenously once only. The study will compare the safety, tolerability, pharmacokinetics (PK) (the levels of drug in the blood), pharmacodynamics (PD) (what the drug does to the body) and immunogenicity (body’s immune response) of the 3 drugs. In order to measure this, blood samples will be collected at various points after treatment has been given.

DISEASE(S): Metastatic Colorectal Cancer,Cancer-bowel-back Passage (rectum) Or Large Bowel (colon),Non-squamous Non-small Cell Lung Cancer,Cancer-lung-non Small Cell

PROVIDER: 2213278 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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A Performance and Bioavailability Study of Entrectinib in Healthy Volunteers.

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Molecular study of the Phyto-Courier Nanotechnology in Salt-Stressed Tomato

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Global comparison of mouse ES cell lines derived from blastocysts and preblastocysts.

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2006-08-14 | E-TABM-129 | biostudies-arrayexpress

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Project description:Induced pluripotent stem cell-derived cardiomyocytes (iPSC-CMs) hold tremendous promise for in vitro modeling to assess native myocardial function and disease mechanisms as well as testing drug safety and efficacy. However, current iPSC-CMs are functionally immature, resembling in vivo CMs of fetal or neonatal developmental states. The use of targeted culture media and organoid formats have been identified as potential high-yield contributors to improve CM maturation. This study presents a novel iPSC-CM maturation medium formulation, designed using a differential evolutionary approach with oxidative capacity as an objective metric for iterative optimization. Relative to gold-standard reference formulations, our approach significantly matured morphology, Ca2+ handling, electrophysiology, and metabolism, which was further validated by multi-omic screening, for cells in either pure or co-cultured microtissue formats. Together, these findings not only provide a reliable workflow for highly functional iPSC-CMs for downstream use, but also demonstrate the power of high-dimensional optimization processes in evoking advanced biological function in vitro.

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