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 3 Part B: treatment-emergent adverse events

System Organ Class Preferred Term	All Placebo (n = 6)	All BITS7201A (n = 20)	Cohort F 150-mg SC (n = 7)	Cohort G 300-mg SC (n = 6)	Cohort H 600-mg SC (n = 6)
Total number of TEAEs	3	8	4	2	2
Number of subjects with at least 1 TEAE	3 (50.0)	6 (30.0)	3 (42.9)	1 (16.7)	2 (33.3)
General disorders and administration site conditions	0	4 (20.0)	2 (28.6)	0	2 (33.3)
Influenza like illness	0	2 (10.0)	0	0	2 (33.3)
Drug withdrawal syndrome	0	1 (5.0)	1 (14.3)	0	0
Injection site bruising	0	1 (5.0)	1 (14.3)	0	0
Infections and infestations	1 (16.7)	2 (10.0)	2 (28.6)	0	0
Otitis media	1 (16.7)	0	0	0	0
Strongyloidiasis	0	1 (5.0)	1 (14.3)	0	0
Viral upper respiratory tract infection	0	1 (5.0)	1 (14.3)	0	0
Nervous system disorders	2 (33.3)	1 (5.0)	0	1 (16.7)	0
Headache	1 (16.7)	0	0	0	0
Nerve compression	1 (16.7)	0	0	0	0
Syncope	0	1 (5.0)	0	1 (16.7)	0
Skin and subcutaneous tissue disorders	0	1 (5.0)	0	1 (16.7)	0
Erythema	0	1 (5.0)	0	1 (16.7)	0

Data are number of subjects (%). SC subcutaneous, TEAE treatment emergent adverse event
^aSubjects with mild atopic asthma

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