TABLE 3.
Summary of TEAEs after single-dose administration.
| SOC PT | Placebo | 10 mg | 40 mg | 100 mg | 200 mg | 300 mg | Total (TT-01025-CL) | Total | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Case | Time | Case | Time | Case | Time | Case | Time | Case | Time | Case | Time | Case | Time | Case | Time | |
| N | 8 | 4 | 6 | 6 | 6 | 6 | 28 | 36 | ||||||||
| Total n (%) | 4 (50.0) | 5 | 3 (75.0) | 6 | 1 (16.7) | 1 | 1 (16.7) | 1 | 1 (16.7) | 1 | 3 (50.0) | 3 | 9 (32.1) | 12 | 13 (36.1) | 17 |
| Infections and infestations, n (%) | 2 (25.0) | 2 | 2 (50.0) | 3 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 2 (33.3) | 2 | 4 (14.3) | 5 | 6 (16.7) | 7 |
| Upper respiratory tract infection, n (%) | 2 (25.0) | 2 | 1 (25.0) | 1 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 2 (33.3) | 2 | 3 (10.7) | 3 | 5 (13.9) | 5 |
| Blepharitis, n (%) | 0 (0) | 0 | 1 (25.0) | 2 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 1 (3.6) | 2 | 1 (2.8) | 2 |
| Investigations n (%) | 2 (25.0) | 2 | 0 (0) | 0 | 1 (16.7) | 1 | 1 (16.7) | 1 | 1 (16.7) | 1 | 1 (16.7) | 1 | 4 (14.3) | 4 | 6 (16.7) | 6 |
| Increased blood uric acid, n (%) | 2 (25.0) | 2 | 0 (0) | 0 | 1 (16.7) | 1 | 1 (16.7) | 1 | 0 (0) | 0 | 0 (0) | 0 | 2 (7.1) | 2 | 4 (11.1) | 4 |
| Increased blood cholesterol, n (%) | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 1 (16.7) | 1 | 1 (3.6) | 1 | 1 (2.8) | 1 |
| Increased blood triglycerides, n (%) | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 1 (16.7) | 1 | 0 (0) | 0 | 1 (3.6) | 1 | 1 (2.8) | 1 |
| Injury, poisoning, and procedural complications, n (%) | 0 (0) | 0 | 1 (25.0) | 1 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 1 (3.6) | 1 | 1 (2.8) | 1 |
| Animal bite, n (%) | 0 (0) | 0 | 1 (25.0) | 1 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 1 (3.6) | 1 | 1 (2.8) | 1 |
| Skin and subcutaneous tissue disorders, n (%) | 0 (0) | 0 | 1 (25.0) | 1 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 1 (3.6) | 1 | 1 (2.8) | 1 |
| Allergic dermatitis, n (%) | 0 (0) | 0 | 1 (25.0) | 1 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 1 (3.6) | 1 | 1 (2.8) | 1 |
| Gastrointestinal disorders, n (%) | 0 (0) | 0 | 1 (25.0) | 1 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 1 (3.6) | 1 | 1 (2.8) | 1 |
| Diarrhea, n (%) | 0 (0) | 0 | 1 (25.0) | 1 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 1 (3.6) | 1 | 1 (2.8) | 1 |
| Cardiac disorders, n (%) | 1 (12.5) | 1 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 1 (2.8) | 1 |
| Sinus bradycardia, n (%) | 1 (12.5) | 1 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 0 (0) | 0 | 1 (2.8) | 1 |
Abbreviations: TEAE, treatment-emergent adverse event; SOC, system organ class; PT, preferred term.