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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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