PK analysis was performed by a non-compartmental method using Phoenix WinNonlin software (version 8.2). Cmax and Tmax were directly obtained from serum concentration data. AUC0-t was calculated using the linear/log trapezoidal method. The elimination rate constant (λz) was estimated using linear least-squares regression analysis of the serum concentration-time data obtained during the terminal log-linear phase. T1/2 was calculated as 0.693/λz. AUC0-∞ was calculated as AUC0-∞ = AUC0-t + Ct/λz, where Ct was the last detectable concentration. The criteria of PK similarity between HOT-1010 and Avastin® was met, when the 90% CIs for GMRs of Cmax, AUC0-t and AUC0-∞ fall within the range of 80.00–125.00%.

The Full Analysis Set (FAS) and Safety Set (SS) included all randomized subjects who received at least one dose of trial medication. The Pharmacokinetic Set (PKS) included all subjects who completed the study without any major protocol deviations impacting PK profile and had measurable concentration. Descriptive statistics were calculated for PK parameters and demographical data. Variance analysis and t-test for normally distributed data and Wilcoxon rank test for non-normally distributed data were used for data analysis. All statistical analyzes were performed with SAS software (version 9.4). p < 0.05 was considered statistically significant.

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