Table 3.
Similarity Analysis of Cmax, AUC0-Inf and AUC0-t
| PK Parameters | N1:N2 | Geometric Mean of CMAB015 Group | Geometric Mean of Secukinumab Group | GMR (CMAB015 Group/ Secukinumab Group) | GMR (90% CI) |
|---|---|---|---|---|---|
| Cmax (µg/mL) | 65:65 | 21.10 | 20.28 | 104.05% | 97.26–111.31% |
| AUC0-inf (h*µg/mL) | 62:65 | 20,132.65 | 21,036.73 | 95.70% | 89.52–102.32% |
| AUC0-t (h*ug/mL) | 65:65 | 18,747.08 | 19,720.13 | 95.07% | 89.17%-101.36% |
Notes: N1: Subjects of CMAB015 group; N2: Subjects of secukinumab group; CI = Confidence interval; GMR = Geometric mean ratio. Variance analysis model was used to analyze the PK parameters following the natural logarithmic transformation. 3 Subjects in CMAB015 group had AUC_%Extrap > 20%, then the respective AUC0-inf was not included in the similarity analysis.