A phase I, randomized, observer-blinded, single and multiple ascending-dose study to investigate the safety, pharmacokinetics, and immunogenicity of BITS7201A, a bispecific antibody targeting IL-13 and IL-17, in healthy volunteers

Table 5 Serum PK parameters of BITS7201A for Part B: SC cohorts, after dosing on Day 1 and Day 57

Parameter	Statistic	Cohort F 150-mg SC		Cohort G 300-mg SC		Cohort H 600-mg SC		Cohort I^a 600-mg SC
Parameter	Statistic	Day 1^b	Day 57	Day 1^b	Day 57	Day 1^b	Day 57^b,c	Day 1
AUC_0-t (day×ng/mL)	GM Mean (CV%)	297,258.1^d (13.6)	835,301.5^d (25.8)	497,570.0^d (35.6)	1,602,363.7^d (43.1)	925,665.2 (35.6)	2,972,662.7 (31.8)	-^d
C_max (ng/mL)	GM Mean (CV%)	13,551.4 (12.9)	21,512.2 (14.2)	22,502.2 (37.7)	39,102.6 (37.4)	53,814.9 (36.1)	91,308.0 (33.4)	43,100.0^e
t_max (day)	Median (range)	5.481 (3.95–13.97)	3.985 (1.94–12.98)	5.929 (3.07–13.96)	3.981 (3.97–4.95)	4.053 (2.96–14.01)	4.543 (2.98–14.01)	4.949^e
k_el (1/day)	Mean (CV%)		0.03240 (22.8)		0.02589 (20.5)		0.03348 (12.0)
t_1/2 (day)	Mean (CV%)		22.26 (21.8)		27.64 (19.4)		20.91 (12.3)
R_ac(Cmax)^f	Mean (CV%)		1.607 (13.4)		1.703 (12.3)		1.956 (22.3)

^aCohort I = 600-mg SC BITS7201A in one subject with mild atopic asthma
^bThe terminal elimination phase for the Day 1 profile for all subjects and for the Day 57 profile for one subject in Cohort H could not be characterized because the time spanned was less than twice the estimated t_1/2
^cDay 57 parameters for two subjects in Cohort H were excluded from the summary statistics and statistical analysis due to a missed dose on Study Day 29
^dAUC_0-t for one subject each in Cohorts F, G, and I was excluded from the summary statistics due to early termination
^eIndividual value is shown
^fR_ac(Cmax) = C_max(Day 57)/C_max(Day 1)
AUC_0-t, area under the concentration-time curve from time 0 to the last quantifiable concentration, C_max maximum serum concentration, CV coefficient of variation, GM Mean geometric mean, k_el elimination rate constant, R_ac(Cmax) accumulation ratio based on C_max, SC subcutaneous, t_max time to maximum serum concentration, t_1/2 half-life

ISSN: 1471-2466