Table 2

PK parameters of ACE910 after single subcutaneous injection of ACE910

ParameterDose of ACE910 (mg/kg)
JapaneseWhite
0.010.10.310.10.31
Cmax (μg/mL) 0.0675 ± 0.0120 0.655 ± 0.0837 1.72 ± 0.377 5.92 ± 1.24 0.603 ± 0.0825 2.12 ± 0.244 5.56 ± 0.812 
Tmax (d) 14.1
(5.00-28.0) 
12.0
(7.00-14.1) 
10.1
(7.00-11.1) 
10.1
(4.00-14.2) 
12.6
(7.00-21.2) 
7.00
(3.00-14.2) 
8.53
(7.00-15.2) 
AUCinf (d × μg/mL) NC 30.2 ± 9.28 86.5 ± 17.9 266 ± 50.0 34.6 ± 12.6 112 ± 18.2 304 ± 79.3 
t1/2 (d) NC 28.3 ± 4.77 30.3 ± 4.12 29.0 ± 3.26 28.8 ± 10.4 34.4 ± 6.55 32.2 ± 6.68 
MRT (d) NC 44.5 ± 6.26 47.3 ± 8.25 43.1 ± 4.57 47.9 ± 14.6 50.8 ± 9.26 49.3 ± 9.96 
CL/F (mL/d/kg) NC 3.51 ± 0.776 3.61 ± 0.845 3.91 ± 0.840 3.16 ± 0.933 2.75 ± 0.470 3.49 ± 0.931 
Vd/F (mL/kg) NC 140 ± 24.1 156 ± 28.8 163 ± 35.6 121 ± 34.8 133 ± 14.9 156 ± 20.3 
ParameterDose of ACE910 (mg/kg)
JapaneseWhite
0.010.10.310.10.31
Cmax (μg/mL) 0.0675 ± 0.0120 0.655 ± 0.0837 1.72 ± 0.377 5.92 ± 1.24 0.603 ± 0.0825 2.12 ± 0.244 5.56 ± 0.812 
Tmax (d) 14.1
(5.00-28.0) 
12.0
(7.00-14.1) 
10.1
(7.00-11.1) 
10.1
(4.00-14.2) 
12.6
(7.00-21.2) 
7.00
(3.00-14.2) 
8.53
(7.00-15.2) 
AUCinf (d × μg/mL) NC 30.2 ± 9.28 86.5 ± 17.9 266 ± 50.0 34.6 ± 12.6 112 ± 18.2 304 ± 79.3 
t1/2 (d) NC 28.3 ± 4.77 30.3 ± 4.12 29.0 ± 3.26 28.8 ± 10.4 34.4 ± 6.55 32.2 ± 6.68 
MRT (d) NC 44.5 ± 6.26 47.3 ± 8.25 43.1 ± 4.57 47.9 ± 14.6 50.8 ± 9.26 49.3 ± 9.96 
CL/F (mL/d/kg) NC 3.51 ± 0.776 3.61 ± 0.845 3.91 ± 0.840 3.16 ± 0.933 2.75 ± 0.470 3.49 ± 0.931 
Vd/F (mL/kg) NC 140 ± 24.1 156 ± 28.8 163 ± 35.6 121 ± 34.8 133 ± 14.9 156 ± 20.3 

Data are presented as mean ± standard deviation for Cmax, AUCinf, t1/2, MRT, CL/F, Vd/F, or median (range) for Tmax. Summary statistics were not calculated when a PK parameter was not calculable in the majority of subjects at a certain dose group.

NC, not calculated (N = 2).

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