Pharmacokinetic Parameters for Course 1: Product ELISA
| Dose (μg/kg/d) . | Day . | (n) . | CpO (U/mL) . | Vd (mL/kg) . | t1/2 (minutes) . | AUC (U/mL · min) . | Clp (mL/kg · min) . |
|---|---|---|---|---|---|---|---|
| 3 | 1 | (1) | 107 | 56 | 30 | 5694 | 1.05 |
| 5 | (1) | NS | NS | NS | NS | NS | |
| 6 | 1 | (2) | 390 ± 314 | 41 ± 33 | 26 ± 12 | 7862 ± 4982 | 1.71 ± 1.08 |
| 5 | (2) | 182 ± 8 | 59 ± 3 | 24 ± 10 | 5471 ± 1249 | 2.01 ± 0.46 | |
| 9 | 1 | (2) | 469 ± 24 | 34 ± 2 | 66 ± 16 | 23902 ± 3167 | 0.68 ± 0.09 |
| 5 | (2) | 467 ± 40 | 35 ± 3 | 72 ± 19 | 30815 ± 5869 | 0.53 ± 0.10 | |
| 12 | 1 | (1) | 345 | 62 | 89 | 36749 | 0.58 |
| 5 | (1) | 463 | 46 | 63 | 33555 | 0.64 | |
| 15 | 1 | (8) | 583 ± 207 | 52 ± 12 | 77 ± 19 | 33571 ± 11468 | 0.93 ± 0.34 |
| 5 | (7) | 601 ± 185 | 51 ± 15 | 73 ± 18 | 38767 ± 13174 | 0.80 ± 0.26 | |
| 19 | 1 | (7) | 1309 ± 2072 | 55 ± 26 | 82 ± 23 | 33482 ± 11499 | 1.09 ± 0.50 |
| 5 | (6) | 1052 ± 1260 | 54 ± 29 | 55 ± 32 | 27083 ± 13306 | 1.60 ± 1.09 | |
| 23 | 1 | (6) | 604 ± 163 | 60 ± 10 | 84 ± 18 | 43799 ± 9944 | 0.84 ± 9944 |
| 5 | (6) | 741 ± 630 | 65 ± 26 | 75 ± 25 | 50939 ± 24115 | 0.79 ± 0.28 | |
| 27 | 1 | (3) | 548 ± 218 | 71 ± 29 | 65 ± 50 | 33921 ± 25797 | 1.41 ± 0.75 |
| 5 | (2) | 461 ± 85 | 77 ± 14 | 123 ± 74 | 43468 ± 27690 | 1.05 ± 0.68 | |
| 31 | 1 | (4) | 1383 ± 1560 | 62 ± 48 | 84 ± 26 | 52956 ± 5785 | 0.76 ± 0.09 |
| 5 | (3) | 6887 ± 10964 | 49 ± 40 | 67 ± 19 | 55847 ± 11101 | 0.73 ± 0.14 |
| Dose (μg/kg/d) . | Day . | (n) . | CpO (U/mL) . | Vd (mL/kg) . | t1/2 (minutes) . | AUC (U/mL · min) . | Clp (mL/kg · min) . |
|---|---|---|---|---|---|---|---|
| 3 | 1 | (1) | 107 | 56 | 30 | 5694 | 1.05 |
| 5 | (1) | NS | NS | NS | NS | NS | |
| 6 | 1 | (2) | 390 ± 314 | 41 ± 33 | 26 ± 12 | 7862 ± 4982 | 1.71 ± 1.08 |
| 5 | (2) | 182 ± 8 | 59 ± 3 | 24 ± 10 | 5471 ± 1249 | 2.01 ± 0.46 | |
| 9 | 1 | (2) | 469 ± 24 | 34 ± 2 | 66 ± 16 | 23902 ± 3167 | 0.68 ± 0.09 |
| 5 | (2) | 467 ± 40 | 35 ± 3 | 72 ± 19 | 30815 ± 5869 | 0.53 ± 0.10 | |
| 12 | 1 | (1) | 345 | 62 | 89 | 36749 | 0.58 |
| 5 | (1) | 463 | 46 | 63 | 33555 | 0.64 | |
| 15 | 1 | (8) | 583 ± 207 | 52 ± 12 | 77 ± 19 | 33571 ± 11468 | 0.93 ± 0.34 |
| 5 | (7) | 601 ± 185 | 51 ± 15 | 73 ± 18 | 38767 ± 13174 | 0.80 ± 0.26 | |
| 19 | 1 | (7) | 1309 ± 2072 | 55 ± 26 | 82 ± 23 | 33482 ± 11499 | 1.09 ± 0.50 |
| 5 | (6) | 1052 ± 1260 | 54 ± 29 | 55 ± 32 | 27083 ± 13306 | 1.60 ± 1.09 | |
| 23 | 1 | (6) | 604 ± 163 | 60 ± 10 | 84 ± 18 | 43799 ± 9944 | 0.84 ± 9944 |
| 5 | (6) | 741 ± 630 | 65 ± 26 | 75 ± 25 | 50939 ± 24115 | 0.79 ± 0.28 | |
| 27 | 1 | (3) | 548 ± 218 | 71 ± 29 | 65 ± 50 | 33921 ± 25797 | 1.41 ± 0.75 |
| 5 | (2) | 461 ± 85 | 77 ± 14 | 123 ± 74 | 43468 ± 27690 | 1.05 ± 0.68 | |
| 31 | 1 | (4) | 1383 ± 1560 | 62 ± 48 | 84 ± 26 | 52956 ± 5785 | 0.76 ± 0.09 |
| 5 | (3) | 6887 ± 10964 | 49 ± 40 | 67 ± 19 | 55847 ± 11101 | 0.73 ± 0.14 |
Mean ± standard deviation.