Assessments
BLOOD
Subjects were screened following the protocol and then randomly assigned to either the test group or the reference group with a single dose of 3 mg/kg of each group administered intravenously for pharmacokineticBlood samples for PK analysis were collected at predose, immediately after the completion of the infusion (within 2 min), followed by 0.75, 2.5, 3.5, 9.5, 13.5, 24, 72, 168, 336, 504, 672, 840, 1008, 1344, and 1680 h after the infusion was completed. There were 17 sampling points in total, with each sample containing 2 ml. Serum samples were stored at − 80 °C, and the serum drug concentration was determined using a validated enzyme-linked immunosorbent assay.Blood samples for ADA/NAb assessment were collected at predose, followed by 336, 672, 1008, and 1680 h after the infusion was completed. There were five blood collection points in total, with each sample containing 3 ml. Until the assay, samples were stored at -80 °C.