TABLE 2.
Overall summary of TEAEs (Safety population).
| n (%) | SAD (part 1a) | PK‐CSF (part 1b) | MAD (part 2) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Placebo (n = 8) | SAR443820 | SAR443820 | Placebo (n = 8) | SAR443820 | ||||||||
| 10 mg (n = 6) | 20 mg (n = 6) | 30 mg (n = 6) | 40 mg (n = 6) | 10 mg (n = 6) | 40 mg (n = 6) | 10 mg q.d. (n = 8) | 20 mg q.d. (n = 8) | 15 mg b.i.d. (n = 8) | 20 mg b.i.d. (n = 8) | |||
| Any TEAE | 5 (62.5) | 2 (33.3) | 1 (16.7) | 3 (50.0) | 3 (50.0) | 4 (66.7) | 6 (100.0) | 5 (62.5) | 4 (50.0) | 3 (37.5) | 6 (75.0) | 4 (50.0) |
| Any grade ≥3 TEAE | 1 (12.5) | 0 | 0 | 0 | 0 | 0 | 1 (16.7) | 0 | 0 | 0 | 0 | 0 |
| Any treatment‐emergent SAE | 0 | 0 | 0 | 0 | 0 | 0 | 1 (16.7) | 0 | 0 | 0 | 0 | 0 |
| Any treatment‐emergent AESI | 0 | 0 | 0 | 0 | 0 | 1 (16.7) | 0 | 0 | 0 | 0 | 1 (12.5) | 0 |
Abbreviations: AESI, adverse event of special interest; b.i.d., twice daily; CSF, cerebrospinal fluid; MAD, multiple ascending dose; PK, pharmacokinetics; q.d., once daily; SAD, single ascending dose; SAE, serious adverse event; TEAE, treatment‐emergent adverse event.