TABLE 2.
Summary of adverse events after the administration of GST-HG141, according to each dose cohort (n = 92)a
| Preferred term | SAD |
MAD |
||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 50 mg (N = 8), n (%) | 100 mg (N = 8), n (%) | 200 mg (N = 8), n (%) | 300 mg, fasted (N = 16), n (%) | 300 mg, fed (N = 16), n (%) | 300 mg, overall (N = 16), n (%) | 400 mg (N = 8), n (%) | 500 mg (N = 8), n (%) | Placebo (N = 12), n (%) | 100 mg BID (N = 10), n (%) | 200 mg BID (N = 10), n (%) | Placebo (N = 4), n (%) | |
| Over with TEAE | 0 | 2 (25.0) | 0 | 0 | 2 (12.5) | 2 (12.5) | 6 (75.0) | 2 (25.0) | 4 (33.3) | 2 (20.0) | 3 (30.0) | 2 (50.0) |
| Serum creatinine increased | 0 | 0 | 0 | 0 | 0 | 0 | 2 (25.0) | 0 | 0 | 0 | 1 (10.0) | 0 |
| ALT increased | 0 | 0 | 0 | 0 | 0 | 0 | 1 (12.5) | 0 | 0 | 0 | 0 | 0 |
| AST increased | 0 | 0 | 0 | 0 | 0 | 0 | 1 (12.5) | 0 | 0 | 1 (10.0) | 0 | 0 |
| CK increased | 0 | 0 | 0 | 0 | 0 | 0 | 1 (12.5) | 0 | 0 | 1 (10.0) | 1 (10.0) | 0 |
| CK-MB increased | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (10.0) | 0 | 0 |
| Serum bilirubin increased | 0 | 0 | 0 | 0 | 0 | 0 | 1 (12.5) | 0 | 0 | 0 | 0 | 1 (25.0) |
| Hypertriglyceridemia | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (12.5) | 0 | 0 | 1 (10.0) | 0 |
| Hypoalbuminemia | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 (16.7) | 0 | 0 | 0 |
| Hyperuricaemia | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (10.0) | 0 | 0 |
| Neutrophil count increased | 0 | 0 | 0 | 0 | 1 (6.3) | 1 (6.3) | 0 | 0 | 0 | 0 | 0 | 0 |
| Neutrophil count decreased | 0 | 1 (12.5) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (10.0) | 0 |
| Lymphocyte count decreased | 0 | 0 | 0 | 0 | 1 (6.3) | 1 (6.3) | 0 | 0 | 0 | 0 | 0 | 0 |
| WBC count increased | 0 | 0 | 0 | 0 | 1 (6.3) | 1 (6.3) | 0 | 0 | 0 | 0 | 0 | 0 |
| WBC count decreased | 0 | 1 (12.5) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (10.0) | 0 |
| Urinary RBC positive | 0 | 1 (12.5) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Urinary sediments positive | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (8.3) | 0 | 0 | 0 |
| Urinary tract infection | 0 | 0 | 0 | 0 | 0 | 0 | 3 (37.5) | 1 (12.5) | 1 (8.3) | 0 | 0 | 1 (25.0) |
| Upper respiratory infection | 0 | 0 | 0 | 0 | 0 | 0 | 1 (12.5) | 0 | 0 | 0 | 0 | 0 |
| Cough | 0 | 0 | 0 | 0 | 1 (6.3) | 1 (6.3) | 0 | 0 | 0 | 0 | 0 | 0 |
| Colporrhagia | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (10.0) | 0 | 0 |
| Myalgia | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (10.0) | 0 | 0 |
N, number of subjects analyzed; n, number of subjects. TEAE, treatment-emergent AE; WBC, white blood cell; RBC, red blood cell.