A Phase I, Randomized, Double-Blind, Single-Dose, Parallel-Group Study To Compare Pharmacokinetic Similarity, Safety, And Immunogenicity Between Bat2506 And Golimumab In Healthy Chinese Male Subjects

Background: To compare the pharmacokinetic (PK) profile, safety, and immunogenicity between golimumab and the biosimilar BAT2506 in healthy Chinese male subjects.Research design and methods: A total of 180 healthy male subjects were recruited for this randomized, double-blinded, single-dose, parallel study. They received 50 mg BAT2506 or golimumab (1:1 ratio) by single subcutaneous injection. The evaluation index included maximum plasma concentration (C-max), area under the plasma concentration-time curve (AUC(0-t), AUC(0-infinity)), safety, and immunogenicity.Results: The results showed that the 90% confidence interval (CI) of the geometric mean ratio (GMR) of BAT2506 to reference drug (golimumab) for C-max, AUC(0-infinity) and AUC(0-t) were 99.26% (90.59-108.76%), 102.06% (93.31%-111.64%), and 102.05% (93.51-111.38%), respectively. All 90% CIs were within the range of 80-125% range, which is the limitation of the equivalence margin. Furthermore, similarity of treatment-emergent adverse events was also found between the two drugs. A total of 14 subjects (7.8%) developed anti-drug antibody after administration.Conclusions: Our study confirmed the PK similarity between BAT2506 and golimumab, and showed good tolerance of BAT2506 in healthy subjects. There were no differences in safety and immunogenicity between the two drugs. Therefore, BAT2506 meets the criteria for biosimilarity to golimumab.