TABLE 2

Summary of PK parameters after single-dose intravenous administration of PSArFVIII presentations or rFVIII to FVIII KO mice

Values in parentheses refer to two-sided 95% confidence intervals; n = 6/group/time point.

Parameter	rFVIII (200 IU/kg)
Parameter	PSAylation Degree: 5.4	PSAylation Degree: 10.4	PSAylation Degree: 13.3	PSAylation Degree: 16.4	PSAylation Degree: 0
	mol/mol	mol/mol	mol/mol	mol/mol	mol/mol
T_max (min)	5	5	5	5	5
C_max (IU/ml)	4.33 (3.89–4.76)	2.92 (1.83–4.01)	3.70 (2.90–4.51)	4.22 (3.82–4.63)	2.40 (1.14–3.66)
IR (IU/ml)/(IU/kg)	0.0143 (0.0129–0.0158)	0.0146 (0.0092–0.0201)	0.0176 (0.0138–0.0214)	0.0154 (0.0139–0.0169)	0.0101 (0.0048–0.0154)
Terminal half-life (h)	7.37 (1.54–13.20)	6.51 (5.19–7.82)	5.14 (4.65–5.63)	7.38 (6.55–8.20)	3.20 (2.71–3.70)
AUC_{0–40 h} (IU/ml⋅h)	27.19 (22.53–31.85)	21.06 (18.24–23.89)	18.86 (17.22–20.50)	26.64 (24.54–28.74)	6.872 (5.711–8.034)
AUC_0–∞ (IU/ml⋅h)	27.69 (23.34–32.04)	21.35 (18.48–24.23)	18.94 (17.28–20.6)	27.25 (25.0–29.5)	6.87 (5.71–8.04)
MRT (h)	8.97 (7.56–10.37)	9.06 (7.85–10.27)	7.21 (6.59–7.83)	10.22 (9.17–11.27)	4.18 (3.57–4.78)
CL (ml/h per kilogram)	10.93 (9.21–12.64)	9.34 (8.1–10.6)	11.11 (10.14–12.09)	10.05 (9.23–10.88)	34.7 (26.83–40.57)
V_dss (ml/kg)	97.96 (78.22–117.7)	84.65 (71.94–97.36)	80.12 (73.08–87.15)	102.7 (93.20–112.3)	144.9 (121.1–168.8)

AUC_{0–40 h}, area under the curve from time 0 to 40 h; AUC_0–∞, area under the curve from time 0 to infinity; CL, clearance; C_max, peak plasma concentration; IR, incremental recovery; T_max, time at C_max; V_dss, volume of distribution at steady state.