Statistical analysis
PD
Given the exploratory nature of this study, no calculation was performed for sample size estimation. The number of subjects was determined according to the requirement of the China Food and Drug Administration (CFDA) for PK studies. The safety analysis set was defined as all patients who received at least one dose of the investigational treatment. The intent-to-treat analysis set was identified as all patients who were randomized. The per protocol analysis set included patients who received all study administrations and had complete and valid data in all study evaluations.Demographics, safety, PK, PD, and biomarker data were summarized descriptively by dose group. Continuous efficacy parameters were summarized by timepoint, using changes from baseline, while the categorical parameters were summarized using only frequencies and incidences. Mean and individual concentration-time profiles were presented graphically as appropriate. The occurrence of ADAs was presented as frequency and percentage of subjects. ACR20 and ACR50 response rates and changes in DAS28 score from baseline were presented by the dose group using frequencies, percentages, and 95% confidence intervals (CIs). The AEs were described with preferred terms and classified into system organ classifications (SOCs) based on MedDRA version 19.0. All statistical analyses were performed using SAS