Table 2.

Adverse events in SAD (Part I) by system organ class

	CJM112 5 mg (n = 4)	CJM112 15 mg (n = 4)	CJM112 50 mg (n = 12)	CJM112 150 mg (n = 4)	CJM112 450 mg (n = 4)	CJM112 Total (n = 28)	Placebo (n = 14)
Patients with AE	1 (25)	2 (50)	5 (41.7)	2 (50)	3 (75)	13 (46.4)	8 (57.1)
System organ class (SOC)
Infections and infestations †	0	1 (25)	3 (25)	0	2 (50)	6 (21.4)	1 (7.1)
Skin and subcutaneous tissue disorders	0	0	0	1 (25)	1 (25)	2 (7.1)	3 (21.4)
Gastrointestinal disorders†‡	0	0	1 (8.3)	1 (25)	1 (25)	3 (10.7)	1 (7.1)
Nervous system disorders	0	1 (25)	2 (16.7)	0	1 (25)	4 (14.3)	0
General disorders and administration site conditions	0	0	1 (8.3)	1 (25)	0	2 (7.1)	1 (7.1)
Investigations	0	0	1 (8.3)	0	1 (25)	2 (7.1)	1 (7.1)
Musculoskeletal and connective tissue disorders	0	0	0	0	1 (25)	1 (3.6)	0
Respiratory, thoracic and mediastinal disorders	1 (25)	1 (25)	0	0	0	2 (7.1)	1 (7.1)
Injury, poisoning and procedural complications	0	0	0	0	1 (25)	1 (3.6)	1 (7.1)
Psychiatric disorders	0	0	0	1 (25)	0	1 (3.6)	1 (7.1)
Blood and lymphatic system disorders	0	0	0	0	0	0	1 (7.1)
Cardiac disorders	0	0	0	0	0	0	1 (7.1)
Immune system disorders	0	0	0	1 (25)	0	1 (3.6)	0
Metabolism and nutrition disorders	0	0	0	1 (25)	0	1 (3.6)	0
Reproductive system and breast disorders	0	0	0	0	0	0	1 (7.1)
Vascular disorders	0	0	0	1 (25)	0	1 (3.6)	0

^†Infections and infestations include cellulitis (n = 1), folliculitis (n = 1), gastroenteritis (n = 2), pneumonia (n = 1) and upper respiratory tract infection (n = 4).

^‡Gastrointestinal disorders include flatulence (n = 1), lip pain (n = 1) and toothache (n = 1). Subjects with multiple adverse events within a body system are counted only once in the table above.