Table 2.
Summary of PK parameters for (a) the intravenous trial and (b) the subcutaneous trial
| Cohort 1 0.1 mg/kg | Cohort 2 0.3 mg/kg | Cohort 3 1.0 mg/kg | Cohort 4 3 mg/kg | Cohort 5 3 mg/kg IgE > 1000 IU/mL | Cohort 6 10 mg/kg | ||
|---|---|---|---|---|---|---|---|
| n = 6 | n = 6 | n = 8 | n = 9 | n = 1 | n = 6 | ||
| (a) | |||||||
| Cmax (μg/mL) | Mean (SD) | 1.94 (0.47) | 5.54 (0.62) | 19.3 (6.8) | 44.6 (6.63) | 59.1 | 158 (24.2) |
| Range | 1.34, 2.63 | 4.89, 6.32 | 3.84, 26.4 | 34.7, 54.0 | NC | 119, 184 | |
| AUC0–113 days (h μg/mL) | Mean (SD) | 124 (62.2) | 608 (95.4) | 2565 (1313) | 9245 (2244) | 6342 | 30269 (6113) |
| Range | 67.9, 225 | 469, 743 | 71.8, 4143 | 5809, 13427 | NC | 20064, 38435 | |
| AUCinf (h μg/mL) | Mean (SD) | 170 (135) | 635 (110) | 2794 (1171) | 9696 (2043) | 6675 | 31072 (6617) |
| Range | 74.3, 428 | 473, 788 | 429, 4363 | 7687, 13627 | NC | 20219, 40445 | |
| T½ (days) | Mean (SD) | 2.8 (2.4) | 4.5 (1.43) | 8.2 (5.7) | 17.4 (4.7) | 13.8 | 23.1 (7.1) |
| Range | 1, 7.7 | 2.5, 6.5 | 2.8, 20 | 12.4, 25.8 | NC | 15, 33 | |
| Cohort 1 0.2 mg/kg | Cohort 2 0.6 mg/kg | Cohort 3 2 mg/kg | Cohort 4 2 mg/kg IgE > 700 IU/mL | Cohort 6 4 mg/kg | |||
| n = 8 | n = 7 | n = 37 | n = 6 | n = 6 | |||
| (b) | |||||||
| Cmax (μg/mL) | Mean (SD) | 1.86 (0.49) | 6.00 (1.83) | 20.7 (5.05) | 16.8 (5.67) | 22.1 (1.92) | |
| Range | 1.04, 2.75 | 3.86, 8.81 | 11.2, 31.1 | 8.58, 25.0 | 19.4, 25.1 | ||
| Tmax (days) | Median | 3.92 | 2.00 | 3.96 | 4.0 | 4.04 | |
| Range | 2.00, 4.12 | 2.00, 5.38 | 1.96, 14.0 | 4.00, 4.34 | 2.00, 4.12 | ||
| AUC0–14 days (h μg/mL) | Mean (SD) | 512 (138) | 1740 (645) | 5500 (1370) | 4120 (1810) | 5900 (449) | |
| Range | 264, 736 | 1120, 2740 | 2810, 7870 | 1990, 7210 | 5450, 6630 | ||
| T½ (days) | Mean (SD) | 14.6 (3.30) | 23.2 (7.44) | 25.9 (7.37) | 13.0 (5.48) | 26.2 (8.12) | |
| Range | 10.3, 21.7 | 16.3, 34.7 | 11.9, 45.1 | 7.54, 21.7 | 16.2, 34.8 | ||
AUC, area under the curve; AUCinf, area under the curve from time zero to infinity; Cmax, peak serum concentration; SD, standard deviation; Tmax, time to reach peak serum concentration; T½, half-life in serum; AUC, area under the curve; Cmax, peak serum concentration; NC, not calculable; SD, standard deviation; T1/2, half-life in serum.