TABLE 2.
Incidences of AEs by preferred term and their severity and causality for all doses within different cohorts.
| SAD cohorts | MAD cohorts | FE cohorts | |||
|---|---|---|---|---|---|
| Placebo, N = 18, n (%) | LYS006, N = 51, n (%) | Placebo, N = 10, n (%) | LYS006, N = 30, n (%) | LYS006, N = 12, n (%) | |
| Subjects with at least one AE | 8 (44.4) | 19 (37.3) | 8 (80.0) | 23 (76.7) | 8 (66.6) |
| Abdominal discomfort or pain | 1 (5.6) | 4 (7.8) | 1 (10) | 2 (6.7) | 2 (16.7) |
| Diarrhea | 3 (16.7) | 2 (3.9) | 1 (10) | 1 (3.3) | 0 (0) |
| Headache | 1 (5.6) | 3 (5.9) | 2 (20) | 8 (26.7) | 1 (8.3) |
| Lipase elevation | 0 (0) | 2 (3.9) | 1 (10) | 3 (10) | 0 (0) |
| Blood CPK elevation | 0 (0) | 0 (0) | 1 (10) | 5 (16.7) | 0 (0) |
| Amylase increase | 0 (0) | 0 (0) | 1 (10) | 2 (6.7) | 0 (0) |
| Back pain | 0 (0) | 1 (2) | 1 (10) | 2 (6.7) | 0 (0) |
| Dizziness | 0 (0) | 1 (2) | 1 (10) | 2 (6.7) | 0 (0) |
| Breast pain | 0 (0) | 0 (0) | 2 (20) | 0 (0) | 0 (0) |
| Nausea | 1 (5.6) | 0 (0) | 0 (0) | 2 (6.7) | 0 (0) |
| Pruritus | 0 (0) | 2 (3.9) | 1 (10) | 0 (0) | 0 (0) |
| Dry skin | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 2 (16.7) |
| Viral respiratory infection | 0 (0) | 0 (0) | 0 (0) | 2 (6.7) | 3 (25) |
| Feeling cold | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 2 (16.7) |
| AE severity | |||||
| Mild | 8 (44.4) | 18 (35.3) | 7 (70.0) | 22 (73.3) | 8 (66.6) |
| Moderate | 1 (5.6) | 2 (3.9) | 1 (10.0) | 4 (13.3) | 0 (0) |
| Severe | 0 (0) | 1 (2) | 1 (10.0) | 4 (13.3) | 0 (0) |
| Study drug‐related AEs | 0 (0) | 4 (7.8) | 1 (10) | 5 (16.7) | 0 (0) |
| SAEs | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| AEs leading to discontinuation | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Deaths | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
Abbreviations: AE, adverse event; CPK, blood creatine phosphokinase; FE, food effect; MAD, multiple ascending dose; SAD, single ascending dose; SAE, serious adverse event.