Table 2 Treatment-related adverse events
Placebo | SHR-1707 | ||||||
|---|---|---|---|---|---|---|---|
2 mg/kg | 6 mg/kg | 20 mg/kg | 40 mg/kg | 60 mg/kg | Total | ||
Study CHN Part 1 | |||||||
Subject No. | 10 | 8 | 8 | 8 | 8 | 8 | 40 |
Any TRAE | 9 (90.0) | 7 (87.5) | 4 (50.0) | 8 (100.0) | 5 (62.5) | 4 (50.0) | 28 (70.0) |
Moderate or severe | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Serious TRAE | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
TRAEs occurring in ≥ 2 subjects across all groups | |||||||
Protein urine present | 3 (30.0) | 2 (25.0) | 0 | 3 (37.5) | 1 (12.5) | 3 (37.5) | 9 (22.5) |
Alanine aminotransferase increased | 2 (20.0) | 4 (50.0) | 0 | 2 (25.0) | 0 | 0 | 6 (15.0) |
Blood uric acid increased | 1 (10.0) | 1 (12.5) | 1 (12.5) | 3 (37.5) | 1 (12.5) | 0 | 6 (15.0) |
Blood triglycerides increased | 2 (20.0) | 1 (12.5) | 1 (12.5) | 1 (12.5) | 0 | 2 (25.0) | 5 (12.5) |
Urine leukocyte esterase positive | 1 (10.0) | 0 | 1 (12.5) | 3 (37.5) | 1 (12.5) | 0 | 5 (12.5) |
White blood cells urine positive | 1 (10.0) | 1 (12.5) | 0 | 2 (25.0) | 1 (12.5) | 0 | 4 (10.0) |
Blood bilirubin unconjugated increased | 1 (10.0) | 0 | 0 | 2 (25.0) | 0 | 0 | 2 (5.0) |
Neutrophil count decreased | 0 | 0 | 0 | 0 | 0 | 2 (25.0) | 2 (5.0) |
Red blood cells urine positive | 0 | 0 | 1 (12.5) | 0 | 0 | 1 (12.5) | 2 (5.0) |
Urinary occult blood positive | 0 | 0 | 1 (12.5) | 1 (12.5) | 0 | 0 | 2 (5.0) |
Blood bilirubin increased | 1 (10.0) | 0 | 0 | 1 (12.5) | 0 | 0 | 1 (2.5) |
Blood creatine phosphokinase MB increased | 1 (10.0) | 1 (12.5) | 0 | 0 | 0 | 0 | 1 (2.5) |
Gamma-glutamyltransferase increased | 2 (20.0) | 0 | 0 | 0 | 0 | 0 | 0 |
Study CHN Part 2 | |||||||
Subject No. | 4 | – | – | 8 | – | – | 8 |
Any TRAE | 2 (50.0) | – | – | 5 (62.5) | – | – | 5 (62.5) |
Moderate or severe | 0 | – | – | 0 | – | – | 0 |
Serious TRAE | 0 | – | – | 0 | – | – | 0 |
TRAEs occurring in ≥ 2 subjects across all groups | |||||||
White blood cells urine positive | 0 | – | – | 2 (25.0) | – | – | 2 (25.0) |
Study AUS | |||||||
Subject No. | 6 | 8 | – | 8 | – | 8 | 24 |
Any TRAE | 3 (50.0) | 2 (25.0) | – | 4 (50.0) | – | 3 (37.5) | 9 (37.5) |
Moderate or severe | 1 (16.7) | 0 | – | 1 (12.5) | – | 0 | 1 (4.2) |
Serious TRAE | 0 | 0 | – | 0 | – | 0 | 0 |
TRAEs occurring in ≥ 2 subjects across all groups | |||||||
Dysgeusia | 0 | 0 | – | 1 (12.5) | – | 1 (12.5) | 2 (8.3) |
Fatigue | 0 | 0 | – | 2 (25.0) | – | 0 | 2 (8.3) |