SOC and PT | Dose group | Total (N = 32) n (%) [F] | ||||
---|---|---|---|---|---|---|
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] | ||
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] |