Preclinical and first-in-human evaluation of AL002, a novel TREM2 agonistic antibody for Alzheimer’s disease

Table 3 Summary of TEAEs in healthy volunteers in the phase 1 study

	AL002								Total AL002 (n = 53)	Pooled Placebo (n = 11)
	0.003-0.2 mg/kg (n = 3)	0.6 mg/kg (n = 6)	2 mg/kg (n = 6)	6 mg/kg (n = 6)	15 mg/kg (n = 6)	30 mg/kg (n = 6)	45 mg/kg (n = 6)	60 mg/kg (n = 14)	Total AL002 (n = 53)	Pooled Placebo (n = 11)
Participants with ≥ 1 TEAE, n (%)	2 (66.7)	3 (50.0)	2 (33.3)	5 (83.3)	5 (83.3)	4 (66.7)	6 (100.0)	10 (71.4)	37 (69.8)	9 (81.8)
Participants with ≥1 treatment-related TEAE, n (%)	2 (66.7)	2 (33.3)	2 (33.3)	2 (33.3)	2 (33.3)	4 (66.7)	5 (83.3)	7 (50.0)	26 (49.1)	6 (54.5)
Treatment-related TEAEs in ≥ 5% of participants in the total AL002 group
Headache Dizziness postural Nausea Vomiting	1 (33.3) 1 (33.3) 0 0	1 (16.7) 0 0 0	2 (33.3) 1 (16.7) 1 (16.7) 0	2 (33.3) 0 1 (16.7) 0	1 (16.7) 0 0 0	4 (66.7) 1 (16.7) 0 0	2 (33.3) 0 1 (16.7) 0	2 (14.3) 0 6 (42.9) 3 (21.4)	15 (28.3) 3 (5.7) 9 (17.0) 3 (5.7)	4 (36.4) 1 (9.1) 1 (9.1) 2 (18.2)
Any SAE, n (%)	0	0	0	0	0	0	0	0	0	1 (9.1)
Any TEAE leading to study drug withdrawal, n (%)	0	0	0	0	0	0	1 (16.7)	1 (7.1)	2 (3.8)	0

A TEAE is defined as an AE that commenced on or after the time of first study drug administration. If a participant has multiple occurrences of a TEAE, the participant is counted only once in the count (n) column for a given System Organ Class and Preferred Term. Any AEs with a missing or unknown severity are counted as severe. A treatment-related TEAE is defined as a TEAE with a relationship to study drug of possible, probable, missing, or unknown. AEs were coded to system organ class and preferred term using MedDRA Version 21.1
AE, adverse event; MedDRA, Medical Dictionary for Regulatory Activities; SAE, serious adverse event; TEAE, treatment emergent adverse event

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