TABLE 1.
Summary of AEs
| SAD part | MAD part | JMAD part | ||||
|---|---|---|---|---|---|---|
| Placebo (n = 10) | Branebrutinib (n = 30) | Placebo (n = 8) | Branebrutinib (n = 24) | Placebo (n = 6) | Branebrutinib (n = 18) | |
| Any AE * | 5 (50.0) | 18 (60.0) | 7 (87.5) | 17 (70.8) | 2 (33.3) | 7 (38.9) |
| Dizziness | 0 (0.0) | 3 (10.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Headache | 3 (30.0) | 4 (13.3) | 1 (12.5) | 8 (33.3) | 0 (0.0) | 1 (5.6) |
| Upper respiratory tract infection | 0 (0.0) | 3 (10.0) | 1 (12.5) | 4 (16.7) | 2 (33.3) | 0 (0.0) |
| Oral herpes | 0 (0.0) | 1 (3.3) | 0 (0.0) | 3 (12.5) | 1 (16.7) | 0 (0.0) |
| Nausea | 0 (0.0) | 2 (6.7) | 1 (12.5) | 2 (8.3) | 0 (0.0) | 0 (0.0) |
| Rash | 0 (0.0) | 2 (6.7) | 1 (12.5) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Myalgia | 0 (0.0) | 2 (6.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Dysmenorrhoea | 0 (0.0) | 2 (6.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (11.1) |
| Tension headache | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (8.3) | 0 (0.0) | 0 (0.0) |
| Throat irritation | 0 (0.0) | 2 (6.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Data are presented as n (%). AEs that occurred at greater frequencies in one treatment group than in the other and occurred in 1 or more participants were included
*
Incidence of any AEs, SAD part: 0.3 mg (n = 4), 1 mg (n = 5), 3 mg (n = 2), 10 mg (n = 5), 30 mg (n = 2); MAD part: 0.3 mg (n = 1), 1 mg (n = 5), 3 mg (n = 6), 10 mg (n = 5); JMAD part: 0.3 mg (n = 2), 3 mg (n = 3), 10 mg (n = 2).
AE: adverse event; JMAD: MAD in first‐generation Japanese participants; MAD: multiple‐ascending dose; SAD: single‐ascending dose