TABLE 1.
Summary of AEs during the Stage 1 period (SS).
| Placebo (n = 8) | HSK21542 | |||||
|---|---|---|---|---|---|---|
| 0.05 μg/kg (n = 8) | 0.15 μg/kg (n = 8) | 0.30 μg/kg (n = 8) | 0.80 μg/kg (n = 9) | Total (n = 33) | ||
| Any AEs, n (%) | 2 (25.0) | 6 (75.0) | 4 (50.0) | 6 (75.0) | 8 (88.9) | 24 (72.7) |
| Any TEAEs, n (%) | 2 (25.0) | 6 (75.0) | 4 (50.0) | 6 (75.0) | 8 (88.9) | 24 (72.7) |
| Grade 1 | 0 | 4 (50.0) | 2 (25.0) | 4 (50.0%) | 4 (44.4) | 14 (42.4) |
| Grade 2 | 2 (25.0) | 2 (25.0) | 2 (25.0) | 2 (25.0%) | 4 (44.4) | 10 (30.3) |
| Drug-related TEAEs, n (%) | 2 (25.0) | 3 (37.5) | 1 (12.5) | 3 (37.5) | 3 (33.3) | 10 (30.3) |
| Grade 2 | 1 (12.5) | 0 | 0 | 0 | 1 (11.1) | 1 (3.0) |
| Any SAEs, n (%) | 0 | 0 | 0 | 0 | 0 | 0 |
| Any TEAEs leading to the drug discontinuation or withdraw from the trial, n (%) | 0 | 0 | 0 | 0 | 0 | 0 |
| Death | 0 | 0 | 0 | 0 | 0 | 0 |
| Most frequently reported TEAEs (≥2 patients) in any treatment group, termed by PT, n (%) | ||||||
| Intradialytic hypotension | 0 | 3 (37·5) | 1 (12·5) | 2 (25·0) | 2 (22·2) | 8 (24·2) |
| Dizziness | 0 | 2 (25·0) | 0 | 1 (12·5) | 3 (33·3) | 6 (18·2) |
| Hypotension | 0 | 2 (25·0) | 0 | 1 (12·5) | 0 | 3 (9·1) |
| Lower abdominal pain | 0 | 0 | 0 | 2 (25·0) | 0 | 2 (6·1) |
| Drug-related TEAE, termed by PT, n (%) | ||||||
| Dizziness | 0 | 1 (12·5) | 0 | 0 | 2 (22·2) | 3 (9·1) |
| Hypotension | 0 | 2 (25.0) | 0 | 1 (12·5) | 0 | 3 (9·1) |
| Paresthesia | 1 (12·5) | 0 | 0 | 1 (12·5) | 1 (11·1) | 2 (6·1) |
| Lower abdominal pain | 0 | 0 | 0 | 2 (25·0) | 0 | 2 (6·1) |
| Headache | 0 | 0 | 1 (12·5) | 0 | 0 | 1 (3·0) |
| Sensation disorders | 0 | 0 | 0 | 0 | 1 (11·1) | 1 (3·0) |
| Abdominal pain | 0 | 0 | 0 | 0 | 1 (11·1) | 1 (3·0) |
| Palpitations | 0 | 0 | 0 | 0 | 1 (11·1) | 1 (3·0) |
| Gastritis | 1 (12·5) | 0 | 0 | 0 | 0 | 0 |
Note. AEs, adverse events; PT, preferred terms; SAEs, serious adverse events; SS, safety set; TEAEs, treatment-emergent adverse events.