Table 2.
Population PK Parameters of Ontamalimab
| Parameter | Estimate (RSE%) | BSV% (RSE%) | Shrinkage (%) |
|---|---|---|---|
| Lag, h | 2.61 (16.5) | NA | NA |
| Ka, h−1 | 0.0187 (10.8) | 61.8 (19.6) | 72.1 |
| CL/F, L/h |
0.0127 (3.73) × (WT/70)0.0034 × (CRP/0.837)0.147 × (ALB/39)−0.889 |
54.6 (7.15) | 10.4 |
| Vc/F, L |
6.53 (2.84) × (WT/70)0.635 |
41.0 (10.6) | 25.0 |
| CLd/F, L/h |
0.000345 (16.3) × (WT/70)0.0034 |
NA | NA |
| Vp/F, L |
0.0216 (16.5) × (WT/70)0.635 |
NA | NA |
| Vmax/F, µg/h |
5.87 (20.8) × (WT/70) 1 .89 |
NA | NA |
| Km, ng/mL | 19.0 (38.3) | NA | NA |
| Error model | |||
| Additive, ng/mL | 166 (34.4) | NA | NA |
| Proportional | 19.6% (10.2) | NA | NA |
ALB, albumin in grams per liter; BSV, between‐subject variability; CL/F, apparent clearance; CLd/F, apparent distributional clearance between the central compartment and the peripheral compartment; CRP, C‐reactive protein; Ka, absorption rate constant; Km, Michaelis‐Menten constant; Lag, absorption lag time; NA, not applicable; RSE, relative standard error; Vc/F, apparent volume of the central compartment; Vmax/F, apparent maximum velocity for the nonlinear elimination; Vp/F, apparent volume of the peripheral compartment; WT, body weight.
The reference subject was a 70‐kg patient with UC or CD, with albumin and CRP levels of 39 g/L and 0.837 mg/dL, respectively.
The condition number is 16 010 (ie, ratio of larger over smaller eigenvalues).