Table 2.
Adverse events following a single oral dose of HMS5552 in healthy subjects
| Adverse events | HMS5552**
|
Total
|
||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 5 mg
|
15 mg
|
25 mg
|
35 mg
|
HMS5552
|
Placebo
|
|||||||
| N (%) | n | N (%) | n | N (%) | n | N (%) | n | N (%) | n | N (%) | n | |
| Number of subjects with any AE | 1 | 3 | 2 | 1 | 7 | 2 | ||||||
| Adverse events | 1 (12.5) | 2 | 3 (37.5) | 3 | 2 (25.0) | 3 | 1 (12.5) | 2 | 7 (14.6) | 10 | 2 (16.7) | 5 |
| Dizziness | 1 (12.5) | 1 | 1 (12.5)* | 1 | 2 (4.2) | 2 | 1 (8.3) | 2 | ||||
| Palpitation | 1 (12.5) | 1 | 1 (12.5)* | 1 | 2 (4.2) | 2 | ||||||
| Cold sweat | 1 (12.5)* | 1 | 1 (2.1) | 1 | ||||||||
| Nausea | 1 (12.5) | 1 | 1 (2.1) | 1 | ||||||||
| Dry mouth | 1 (12.5) | 1 | 1 (2.1) | 1 | ||||||||
| Vomiting | 1 (8.3)* | 1 | ||||||||||
| Belching | 1 (8.3)* | 1 | ||||||||||
| Bulbar hyperemia | 1 (8.3) | 1 | ||||||||||
| Urinary WBC | 1 (12.5) | 1 | 1 (12.5) | 1 | 2 (4.2) | 2 | ||||||
| Proteinuria | 1 (12.5)* | 1 | 1 (2.1) | 1 | ||||||||
Notes: N, number of subjects; n, number of adverse events (AEs).
*
Adverse event was considered to be related to HMS5552 by the blinded investigator.
**
No adverse events in the 10 or 50 mg HMS5552 group.
Abbreviation: WBC, white blood cells.