Table 4.
Summary of PK parameters for mAb992 after a single dose of Sym004 at wk 1 and wk 4 (weekly regimens) or wk 5 (biweekly regimens)
| Geometric mean (GCV%) | |||||||
|---|---|---|---|---|---|---|---|
| AUC0‐inf (μg.h/mL) | AUC0‐inf/dose (μg.h/mL/mg) | C max (μg/mL) | t max (h)a | t 1/2 (h) | CL (L/h) | V z (L) | |
| Wk 1 | |||||||
| 6 mg/kg weekly (n = 3) | 4471 (35.0) | 27.30 (26.7) | 50.13 (29.2) | 2.07 (2.0, 14) | 66.48 (10.0) | 0.037 (26.7) | 3.51 (36.1) |
| 9/6 mg/kg weekly (n = 6) | 7693 (38.3) | 30.33 (37.7) | 85.09 (25.3) | 5.12 (3.1, 7.2) | 79.04 (18.8) | 0.033 (37.7) | 3.76 (21.9) |
| 12 mg/kg weekly, Part A (n = 6) | 11 970 (34.2) | 34.47 (22.5) | 120.37 (33.6) | 5.73 (3.0, 11) | 82.87 (21.1) | 0.029 (22.5) | 3.47 (17.8) |
| 18 mg/kg biweekly (n = 6) | 19 896 (28.9) | 33.77 (30.3) | 157.71 (18.6) | 7.21 (3.2, 15) | 111.7 (18.9) | 0.030 (30.3) | 4.77 (23.3) |
| 12 mg/kg weekly, Part B (n = 7) | 9677 (22.3) | 31.05 (24.6) | 88.59 (15.0) | 6.30 (3.2, 11) | 87.26 (21.1) | 0.032 (24.6) | 4.05 (10.8) |
| Wk 4 or 5 | |||||||
| 6 mg/kg weekly (n = 3) | ND | ND | 76.09 (16.4) | 10.1 (6.0, 14) | ND | ND | ND |
| 9/6 mg/kg weekly (n = 5) | 9662.7 (51.4) | 59.65 (37.3) | 86.76b (34.0) | 5.94b (2.0, 10) | 85.23 (24.4) | 0.023 (27.3) | 2.79 (15.4) |
| 12 mg/kg weekly, Part A (n = 6) | 27 409 (79.0) | 77.86 (65.2) | 181.6 (31.6) | 9.13 (7.1, 11) | 136.0 (52.5) | 0.023 (29.3) | 4.48 (26.2) |
| 18 mg/kg biweekly (n = 5) | 30 127 (36.6) | 51.67 (36.2) | 187.4b (24.3) | 7.03b (3.1, 11) | 130.4 (26.4) | 0.024 (29.9) | 4.40 (24.4) |
| 12 mg/kg weekly, Part B (n = 5) | 22 240 (14.4) | 72.22 (17.1) | 143.8b (23.4) | 5.13b (2.9, 11) | 132.1 (13.9) | 0.024 (15.0) | 4.44 (17.9) |
AUC0‐inf, area under the curve from start of first infusion extrapolated to infinity; C max, maximum concentration; t max, time to C max; t 1/2, half‐life; CL, clearance; V z, apparent volume of distribution during the terminal phase; GCV%, geometric coefficient of variation; ND, not determined.
a
Median and range are reported.
n = 6.