Table 3.
U3–1565 single dose plasma PK parameters in Part 1, Cycle 1
| Cohort 1 (2 mg/kg) | Cohort 2 (8 mg/kg) | Cohort 3 (16 mg/kg) | Cohort 4 (24 mg/kg) | Cohort 5 (24 mg/kg) | |
|---|---|---|---|---|---|
| n | 3 | 3 | 3 | 3 | 3 |
| Cmax (μg/mL) | 57.9 (8.17) | 150 (10.4) | 386 (111) | 493 (74.6) | 496 (147) |
| tmax (h) | 1.00 (0.98–1.03) | 1.03 (1.02–3.67) | 3.82 (0.97–6.72) | 1.07 (1.05–25.17) | 1.08 (0.97–2.05) |
| AUClast (mg h/mL)# | 7.95 (1.62) | 35.5 (2.79) | 62.6 (42.4) | 106 (19.5) | 47.2 (13.0) |
| Half-life (h)#* | 237 (18.5) | 304 (N/A) | 175 (N/A) | 404 (125) | 109 (10.5) |
#
PK parameters were calculated using time points collected following the first dose administration, and up until the second dose: Up to 3 weeks for Cohorts 1–4, and up to 1 week for Cohort 5.
*
For Cohorts 2 and 3, half-life was only evaluable for 2 subjects. Mean (standard deviation) is reported above. For tmax, median (min, max) is reported. n = number of subjects; N/A = no reportable value