A Phase 1, randomized, double-blind, placebo-controlled, single- and multiple-dose escalation study to evaluate the safety and pharmacokinetics/pharmacodynamics of PF-06835375, a C-X-C chemokine receptor type 5 directed antibody, in patients with systemic lupus erythematosus or rheumatoid arthritis

Table 3 Descriptive summary of serum PK parameters for PF-06835375 in IV SAD cohorts (PK analysis population)

PK parameters (unit)^a	PF-06835375 IV SAD cohorts
PK parameters (unit)^a	0.03 mg (n = 2)	0.1 mg (n = 1)	0.3 mg (n = 3)	1 mg (n = 3)	3 mg (n = 6)	6 mg (n = 5)
AUC_inf (ng/h/mL), geometric mean (CV)	35.6, 95.7	-	1573 (2409)	7467 (84)	88,190 (35)	288,000 (30)
AUC_last (ng/h/mL), geometric mean (CV)	28.0, 67.9	39.1	1380 (2950)	7327 (85)	87,120 (36)	287,400 (30)
C_max (ng/mL), geometric mean (CV)	6.4, 7.4	10.8	103 (197)	208.7 (28)	994.7 (29)	2645 (13)
T_max (h), median (range)	2.0, 2.0	2.2	2.2 (2.2–2.2)	2.1 (2.1–4.2)	2.2 (2.2–4.1)	4.0 (2.0–8.1)
t_½ (h), arithmetic mean (SD)	3.4, 12.8	-	35.1 (44.5)	52.5 (14.4)	91.4 (25.6)	121.4 (33.9)
CL (L/h), geometric mean (CV)	0.31, 0.84	-	0.19 (2420)	0.13 (84)	0.03 (35)	0.02 (29)

The PK analysis population included all patients who received at least one dose of the study treatment and had evaluable PK data
AUC_inf area under the concentration–time curve from zero to infinity, AUC_last area under the concentration–time curve from time zero to time of last quantifiable concentration, CL clearance, C_max maximum observed concentration, CV coefficient of variation, IV intravenous, PK pharmacokinetics, SAD single ascending dose, SD standard deviation, t_½ terminal phase half-life, T_max time to first occurrence of C_max
^aIndividual values are listed when there were less than three evaluable measurements

ISSN: 1478-6362