A phase 1, randomized, open-label, single-dose study to assess the relative bioavailability of a subcutaneous dose of FKB327 when administered using a prefilled syringe, a prefilled auto-injector, or a vial with disposable syringe in healthy subjects

Table 2 Pharmacokinetic Parameters

Parameter	FKB327 vial n = 65	FKB327 PFS n = 63	FKB327 AI n = 65
Primary
AUC_0-t (h*ng/mL)	2,150,000 (54.7)	2,140,000 (43.0)	2,380,000 (36.5)
AUC_0-∞ (h*ng/mL)	2,380,000 (39.1)^c	2,300,000 (39.5)^b	2,460,000 (38.7)^c
C_max (ng/mL)	3450 (31.4)^a	3450 (30.1)^a	3590 (27.9)^a
Secondary
AUC_0-360h (h*ng/mL)	999,000 (41.3)	998,000 (32.4)	1,080,000 (27.4)
t_max (h)	120 (72.0, 363)	120 (48.0, 363)	144 (48.0, 363)
t_1/2 (h)	305 (47.9)^c	307 (49.7)^b	306 (42.1)^c
k_el (h)	0.00227 (47.9)^c	0.00225 (49.7)^b	0.00226 (42.1)^c

^amedian (range); ^bn = 56; ^cn = 60
AI indicates prefilled autoinjector; AUC_0-t area under the serum concentration-time curve to the last detectable value; AUC_0-∞ area under the serum concentration-time curve extrapolated to infinity; AUC_0-360h area under the serum concentration-time curve from zero to 360 h; C_max peak serum concentration; k_el elimination rate constant; PFS prefilled syringe; t_max maximum concentration; t_1/2 elimination half-life; vial, vial with disposable syringe

ISSN: 2050-6511