Safety, tolerability of ES16001, a novel varicella zoster virus reactivation inhibitor, in healthy adults

Table 3 Summary of ADRs by treatment, SOC, and PT: SAD study

SOC and PT	Dose group					Total (N = 32) n (%) [F]
SOC and PT	240 mg (N = 6) n (%) [F]	480 mg (N = 6) n (%) [F]	960 mg (N = 6) n (%) [F]	1440 mg (N = 6) n (%)[F]	Placebo (N = 8) n (%)[F]	Total (N = 32) n (%) [F]
Subjects with AEs	1 (16.7) [4]	1 (16.7) [1]	1 (16.7) [2]	1 (16.7) [3]	1 (12.5) [1]	5 (15.6) [11]
Fever			1 (16.7) [1]			1 (3.1) [1]
Fever			1 (16.7) [1]			1 (3.1) [1]
Nervous system disorders					1 (12.5) [1]	1 (3.1) [1]
Headache					1 (12.5) [1]	1 (3.1) [1]
General disorders and administration site conditions	1 (16.7) [2]					1 (3.1) [2]
Pyrexia	1 (16.7) [1]					1 (3.1) [1]
Chills	1 (16.7) [1]					1 (3.1) [1]
Investigations						2 (6.3) [4]
c-Reactive protein increased	1 (16.7) [2]			1 (16.7) [2]		1 (3.1) [1]
Aspartate aminotransferase increased	1 (16.7) [1]			1 (16.7) [1]		1 (3.1) [1]
Alanine aminotransferase increased	1 (16.7) [1]			1 (16.7) [1]		2 (6.3) [2]
Gastrointestinal disorders				1 (16.7) [1]		2 (6.3) [2]
Diarrhea		1 (16.7) [1]		1 (16.7) [1]		1 (3.1) [1]
Abdominal discomfort		1 (16.7) [1]				1 (3.1) [1]
Upper respiratory infection			1 (16.7) [1]			1 (3.1) [1]
Upper respiratory infection			1 (16.7) [1]			1 (3.1) [1]

Dictionary: MedDRA 23.0
SOC: System Organ Class and PT: Preferred Term
Subject is counted once at the maximum intensity if the subject reported one or more events
Percentages are based on the subjects within each treatment

ISSN: 2047-783X