A Study to Evaluate the Safety and Pharmacokinetics of Bevacizumab After a Single Dose in Healthy Males

ABSTRACT: Interventions: Arm 1: 25 mg/mL BP01 (bevacizumab biosimilar) administered as single intravenous infusion of 1 mg/kg over a period of approximately 90 minutes. Primary outcome(s): To determine the pharmacokinetic profile of BP01 following a single intravenous administration of 1 mg/kg in healthy male subjects. PK parameters determined are to include AUC(0-inf), AUC(0-t), C(max), residual area, T(max), T(1/2 el), K(el), Cl and V(d).[Blood PK samples will be collected for analysis during the treatment period at: pre-infusion (0 hour), prior to end of infusion (within 5 minutes before end of infusion), and at 2, 4, 6, 9, 12, 24, 48 (Day 3), 72 (Day 4), 168 (Day 8), 336 (Day 15), 504 (Day 22), 1008 (Day 43), 1512 (Day 64), and 2016 hours (Day 85).];To determine the pharmacokinetic profile of US-licensed Avastin following a single intravenous administration of 1 mg/kg in healthy male subjects. PK parameters determined are to include AUC(0-inf), AUC(0-t), C(max), residual area, T(max), T(1/2 el), K(el), Cl and V(d).[Blood PK samples will be collected for analysis during the treatment period at: pre-infusion (0 hour), prior to end of infusion (within 5 minutes before end of infusion), and at 2, 4, 6, 9, 12, 24, 48 (Day 3), 72 (Day 4), 168 (Day 8), 336 (Day 15), 504 (Day 22), 1008 (Day 43), 1512 (Day 64), and 2016 hours (Day 85).];To determine the pharmacokinetic profile of EU-licensed Avastin following a single intravenous administration of 1 mg/kg in healthy male subjects. PK parameters determined are to include AUC(0-inf), AUC(0-t), C(max), residual area, T(max), T(1/2 el), K(el), Cl and V(d).[Blood PK samples will be collected for analysis during the treatment period at: pre-infusion (0 hour), prior to end of infusion (within 5 minutes before end of infusion), and at 2, 4, 6, 9, 12, 24, 48 (Day 3), 72 (Day 4), 168 (Day 8), 336 (Day 15), 504 (Day 22), 1008 (Day 43), 1512 (Day 64), and 2016 hours (Day 85).] Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Bio-equivalence

DISEASE(S): Ovarian Or Primary Peritoneal Cancer,Cancer-brain,Glioblastoma,Colorectal Cancer,Breast Cancer,Cancer-breast,Cancer-lung-non Small Cell,Cervical (cervix) Cancer,Cancer-kidney,Non-small Cell Lung Cancer,Renal Cancer,Cancer-cervical (cervix),Cancer-ovarian And Primary Peritoneal,Cancer-bowel-back Passage (rectum) Or Large Bowel (colon)

PROVIDER: 2469724 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR