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 6 ADA incidence and PK parameters in ADA- and ADA+ subjects

		ADA incidence in each cohort		PK parameters
Cohort, Dose	n	ADA-n (%)	ADA+n (%)	Elimination half-life, t_1/2 (d), mean ± SD		Apparent clearance (L/d), mean ± SD
Part A: SAD^a				ADA-	ADA+	ADA-	ADA+
A, 30-mg SC	6	6 (100)	0 (0)	25.5 ± 2.1	NA	0.22 ± 0.06	NA
B, 90-mg SC	6	2 (33)	4 (67)	19.4, 21.4^c	14.4 ± 2.3	0.24, 0.013^c	0.28 ± 0.10
C, 300-mg SC	6	3 (50)	3 (50)	28.1 ± 5.5	20.7 ± 8.2	0.19 ± 0.03	0.30 ± 0.12
D, 300-mg IV	6	1 (17)	5 (83)	23.3^c	18.9 ± 4.8	0.23^c	0.29 ± 0.22
E, 750-mg IV	6	2 (33)	4 (67)	19.4, 27.4^c	23.9 ± 9.6	0.21, 0.16^c	0.21 ± 0.04
All BITS7201A	30	14 (47)	16 (53)
Placebo	10	9 (90)	1 (10)
Part B: MAD^b
F, 150-mg SC	5	1 (20)	4 (80)	ND	ND	ND	ND
G, 300-mg SC	6	0 (0)	6 (100)	ND	ND	ND	ND
H, 600-mg SC	6	0 (0)	6 (100)	ND	ND	ND	ND
I, 600-mg SC	n/a^d	–	–	ND	ND	ND	ND
All BITS7201A	17	1 (5.9)	16 (94.1)
Placebo	5	4 (80)	1 (20)

^aBaseline ADA prevalence (Part A, Day 1): 3 of 39 subjects (7.7%); n = 39 because one BITS7201A-treated subject in Cohort C did not have a Day 1 sample
^bBaseline ADA prevalence (Part B, Day 1): 1 of 22 subjects (4.5%)
^cFor n ≤ 2, individual values are provided instead of mean ± SD
^dSample not available for testing
ND, not done because only 1 subject in Part B was ADA-negative
ADA-, ADA-negative; ADA+, ADA-positive

ISSN: 1471-2466