From: Single low-dose rHuIL-12 safely triggers multilineage hematopoietic and immune-mediated effects
 | PK Parameter | ||||||
---|---|---|---|---|---|---|---|
Study | Dose | Statistic | Initial T ½ | Terminal T ½ | T max | C max | AUC 0-t |
(μg) |  | (h) | (h) | (h) | (pg/mL) | (h*pg/mL) | |
FIH | Â | Â | Â | Â | Â | Â | Â |
 | 2 | N | 4 | 4 | 4 | 4 | 4 |
 |  | Mean ± SD | NR | NR | 8.00 (8.00 – 8.00)a | 5.55 ± 1.34 | 45.28 ± 11.30 |
 | 5 | N | 4 | 4 | 4 | 4 | 4 |
 |  | Mean ± SD | NR | NR | 5.00 (2.00 - 8.00)a | 16.52 ± 2.87 | 154.22 ± 56.41 |
 | 10 | N | 3 | 4 | 4 | 4 | 4 |
 |  | Mean ± SD | 11.8 ± 1.79 | 89.56 ± 57.61 | 8.00 (5.00 - 8.00)a | 26.39 ± 3.90 | 1169.86 ± 513.05 |
 | 12 | N | 4 | 4 | 4 | 4 | 4 |
 |  | Mean ± SD | 9.23 ± 5.78 | 48.92 ± NR | 8.00 (8.00 - 12.00)a | 45.41 ± 43.46 | 790.74 ± 305.24 |
 | 15 | N | 4 | 4 | 4 | 4 | 4 |
 |  | Mean ± SD | 8.71 ± 6.54 | 90.19 ± 68.49 | 5.00 (5.00 - 8.00)a | 96.81 ± 57.12 | 1436.67 ± 602.18 |
 | 20 | N | 1 | 1 | 1 | 1 | 1 |
 |  | Mean ± SD | 7.22 | 83.05 | 12.00b | 39.50 | 970.58 |
Expansion | Â | Â | Â | Â | Â | Â | Â |
 | 12 | N | 27 | 10 | 32 | 32 | 32 |
 |  | Mean ± SD | 8.74 ± 4.73 | 56.92 ± 42.20 | 8.00 (2.00 – 24.00)a | 57.67 ± 49.84 | 1016.07 ± 612.97 |