Table 2.
Pharmacokinetic Parameters of CMAB015 and Secukinumab - PK Parameter Analysis Set
| Group | Statistical Magnitude | Cmax (µg/mL) | AUC0-inf (h*µg/mL) | AUC0-t (h*µg/mL) | Tmax (h) | t1/2 (h) | λz (h−1) | CL/F (mL/h) | Vd/F (mL) | AUC_%Extrap (%) |
|---|---|---|---|---|---|---|---|---|---|---|
| CMAB015 group | Number | 65 | 62 | 65 | 65 | 62[a] | 62[a] | 62[a] | 62[a] | 62[a] |
| Mean | 21.60 | 20,548.666 | 19,142.748 | 113.7072 | 617.3361 | 0.0011 | 7.6131 | 6678.1849 | 5.450 | |
| SD | 4.71 | 4124.884 | 3864.313 | 37.5369 | 93.2107 | 0.0002 | 1.6533 | 1267.8308 | 2.581 | |
| CV | 21.79 | 20.07 | 20.19 | 33.01 | 15.10 | 15.84 | 21.72 | 18.98 | 47.36 | |
| Median | 21.50 | 20,814.602 | 19,537.949 | 95.9833 | 611.2085 | 0.0011 | 7.2066 | 6556.1400 | 5.345 | |
| Min | 12.1 | 12,495.24 | 10,518.26 | 71.9833 | 435.694 | 0.001 | 4.670 | 4030.108 | 1.54 | |
| Max | 34.7 | 32,120.77 | 30,115.40 | 191.9833 | 833.843 | 0.002 | 12.005 | 10,261.878 | 16.64 | |
| Geometric mean | 21.10 | 20,132.650 | 18,747.080 | 108.7461 | 610.2528 | 0.0011 | 7.4506 | 6559.5586 | 4.907 | |
| Geometric CV | 22.28 | 20.89 | 21.15 | 29.36 | 15.54 | 15.54 | 20.89 | 19.39 | 49.63 | |
| Secukinumab group | Number | 65 | 65 | 65 | 65 | 65 | 65 | 65 | 65 | 65 |
| Mean | 20.86 | 21,675.872 | 20,250.952 | 135.5190 | 656.5381 | 0.0011 | 7.3424 | 6825.1246 | 6.228 | |
| SD | 4.91 | 5507.410 | 4817.218 | 63.0677 | 102.2085 | 0.0002 | 1.8013 | 1458.3600 | 2.407 | |
| CV | 23.52 | 25.41 | 23.79 | 46.54 | 15.57 | 14.65 | 24.53 | 21.37 | 38.65 | |
| Median | 20.90 | 21,465.625 | 20,074.136 | 95.9833 | 648.8537 | 0.0011 | 6.9879 | 6722.4651 | 6.174 | |
| Min | 11.3 | 12,064.76 | 11,891.90 | 71.9833 | 465.000 | 0.001 | 3.497 | 4228.104 | 1.43 | |
| Max | 31.4 | 42,895.84 | 37,463.47 | 337.7333 | 974.695 | 0.001 | 12.433 | 10,936.106 | 12.66 | |
| Geometric mean | 20.28 | 21,036.729 | 19,720.131 | 124.2460 | 649.1335 | 0.0011 | 7.1304 | 6677.6188 | 5.751 | |
| Geometric CV | 24.72 | 24.89 | 23.43 | 41.89 | 15.11 | 15.11 | 24.89 | 21.23 | 43.95 |
Notes: a3 Subjects in CMAB015 group had AUC_%Extrap > 20%, then the respective other PK parameters (t1/2, λz, AUC0-inf, CL/F, Vd/F, AUC_%Extrap) were not performed descriptive statistical analysis.