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 3 Summary of ANOVA for Pharmacokinetic Parameters

Parameter	Ratio of Geometric LS Means (90% CI)
Parameter	FKB327 PFS/FKB327 vial	FKB327 AI/FKB327 vial	FKB327 AI/FKB327 PFS
Primary
AUC_0-t (h*ng/mL)	0.994 (0.877, 1.13)	1.11 (0.976, 1.254)	1.11 (0.981, 1.26)
AUC_0-∞ (h*ng/mL)	0.967 (0.861, 1.09)	1.04 (0.925, 1.16)	1.07 (0.954, 1.20)
C_max (ng/mL)	1.00 (0.918, 1.09)	1.04 (0.957, 1.13)	1.04 (0.957, 1.13)
Secondary
t_1/2 (h)	1.01 (0.880, 1.16)	1.00 (0.877, 1.15)	0.995 (0.868, 1.14)
t_max (h)	0 (−24.0, 0)	0 (−24.0, 23.9)	0 (0, 24.0)

AI indicates prefilled autoinjector; ANOVA analysis of variance; 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; CI confidence interval; C_max, peak serum concentration; LS least squares; PFS prefilled syringe; t_max maximum concentration; t_1/2 elimination half-life; vial, vial with disposable syringe

ISSN: 2050-6511