|
Parameter
|
MEDI-546
|
|---|
|
0.1 mg/kg single dose
|
0.3 mg/kg single dose
|
1.0 mg/kg single dose
|
3.0 mg/kg single dose
|
10.0 mg/kg single dose
|
20.0 mg/kg single dose
|
0.3 mg/kg/week multiple dose
|
1.0 mg/kg/week multiple dose
|
5.0 mg/kg/week multiple dose
|
|---|
|
1stdose
|
4thdose
|
1stdose
|
4thdose
|
1stdose
|
4thdose
|
|---|
|
Number of subjects
|
1
|
4
|
4
|
4
|
4
|
4
|
4
|
4
|
4
|
4
|
5
|
3
|
|
Cmax, mean (SD), μg/mL
|
1.97 (NA)
|
6.69 (1.47)
|
23.3 (2.22)
|
72.4 (13.7)
|
213 (44.0)
|
394 (83.5)
|
6.43 (0.470)
|
6.32 (1.01)
|
19.1 (7.80)
|
35.8 (15.5)
|
87.6 (19.3)
|
135 (26.5)
|
|
AUCa, mean (SD), μg · day/mL
|
2.45 (NA)
|
12.4 (4.91)
|
102 (14.1)
|
497 (105)
|
2610 (728)
|
4870 (1750)
|
NA
|
10.7 (2.53)
|
NA
|
159 (68.9)
|
NA
|
849 (165)
|
|
CL, mean (SD), mL/kg/day
|
40.8 (NA)
|
27.4 (11.0)
|
9.94 (1.44)
|
6.26 (1.43)
|
4.07 (1.13)
|
4.67 (2.18)
|
NA
|
NA
|
NA
|
NA
|
NA
|
NA
|
|
t1/2, mean (SD), d
|
0.84 (NA)
|
1.24 (0.358)
|
2.96 (0.593)
|
4.07 (1.23)
|
7.70 (2.26)
|
11.8 (2.06)
|
NA
|
1.06 (0.174)
|
NA
|
4.94 (1.47)
|
NA
|
6.28 (0.921)
|
- aAUCinf for single-dose groups and AUC0–7 for multiple-dose groups.
- AUCinf area under the serum concentration-time curve from zero to infinity; AUC0–7, AUC from day 0 to day 7 post dose administration; CL, systemic clearance; Cmax, maximum serum concentration; d, days; NA, not available; SD, standard deviation; t1/2, serum elimination half-life.
