Table 2.
Descriptive Statistics of PK Parameter Estimates after QW and Q2W Administration of AKR-001
| PK Parameter | AKR-001 QW |
AKR-001 Q2W |
|||||||
|---|---|---|---|---|---|---|---|---|---|
| 7 mg | 21 mg | 70 mg | 140mg | 7 mg | 21 mg | 70 mg | 140 mg | ||
| Day 1 | n | 7 | 6 | 6 | 9 | 6 | 6 | 6 | 6 |
| mean Cmax, ng/mL (% CV) | 297 (71.6) | 806 (76.8) | 2,600 (67.4) | 7,590 (43.7) | 193 (16.6) | 1,010 (37.1) | 2,110 (76.6) | 6,810 (33.4) | |
| mean AUC0–τ, day⋅ng/mL (% CV) | 1,450 (72.5) | 4,060 (73.6) | 13,300 (67.8) | 36,700 (36.2) | 1,490 (17.4) | 7,170 (21.4) | 17,500 (80.1) | 50,600 (35.4) | |
| Day 15 (Q2W) or day 22 (QW) | n | 6 | 6 | 6 | 5 | 6 | 6 | 6 | 6 |
| mean Cmax, ng/mL (% CV) | 440 (47.1) | 2,290 (51.3) | 6,260 (48.3) | 11,900 (83.1) | 236 (50.2) | 881 (47.0) | 3,140 (69.5) | 7,530 (49.5) | |
| mean AUC0–τ, day⋅ng/mL (% CV) | 2,260 (43.6) | 10,700 (48.4) | 31,900 (48.5) | 57,500 (70.4) | 1,750 (44.5) | 6,110 (35.4) | 27,800 (78.5) | 55,600 (44.4) | |
| t1/2,z, days (% CV) | 3.24 (23.5) | 2.56 (12.0) | 3.30 (12.7) | 3.54 (13.8) | 2.81a (30.2) | 3.27b (13.2) | 3.29 (7.1) | 3.44 (11.3) | |
QW, once weekly; Q2W, once every 2 weeks; n, number of subjects per group; % CV, coefficient of variation expressed as percent; Cmax, maximum observed concentration; AUC0–τ, area under the concentration-time curve during the inter-dose interval, post-dose; τ, inter-dose interval (QW = 7 days, Q2W = 14 days); t1/2,z, terminal half-life.
a
N = 4.
b
N = 5.