TABLE 1.
Demographics and baseline characteristics (Safety population).
| Characteristic | 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) | |||
| Age, years, mean (SD) | 34.5 (11.0) | 29.0 (5.9) | 36.2 (12.8) | 32.8 (10.7) | 25.3 (8.2) | 29.3 (11.9) | 29.5 (12.9) | 35.0 (13.2) | 31.0 (5.1) | 28.9 (8.1) | 37.5 (10.8) | 28.3 (6.4) |
| Sex, n (%), Male | 2 (25.0) | 3 (50.0) | 2 (33.3) | 4 (66.7) | 0 | 4 (66.7) | 6 (100.0) | 5 (62.5) | 3 (37.5) | 5 (62.5) | 6 (75.0) | 6 (75.0) |
| Race, n (%), White | 6 (75.0) | 4 (66.7) | 5 (83.3) | 4 (66.7) | 6 (100.0) | 5 (83.3) | 6 (100.0) | 6 (75.0) | 4 (50.0) | 8 (100) | 6 (75.0) | 5 (62.5) |
| Weight, kg, mean (SD) | 70.4 (13.0) | 71.5 (8.5) | 69.1 (7.0) | 76.1 (11.8) | 58.4 (9.5) | 72.3 (14.0) | 81.8 (8.1) | 80.8 (11.8) | 74.1 (10.0) | 82.5 (10.5) | 76.9 (11.1) | 81.7 (9.1) |
| BMI, kg/m2, n (%) | ||||||||||||
| 18.5 to <25 | 6 (75.0) | 5 (83.3) | 3 (50.0) | 3 (50.0) | 5 (83.3) | 4 (66.7) | 3 (50.0) | 4 (50.0) | 2 (25.0) | 1 (12.5) | 5 (62.5) | 3 (37.5) |
| 25 to <30 | 2 (25.0) | 1 (16.7) | 3 (50.0) | 3 (50.0) | 1 (16.7) | 2 (33.3) | 3 (50.0) | 4 (50.0) | 5 (62.5) | 6 (75.0) | 3 (37.5) | 5 (62.5) |
| ≥30 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (12.5) | 1 (12.5) | 0 | 0 |
Abbreviations: b.i.d., twice daily; BMI, body mass index; CSF, cerebrospinal fluid; MAD, multiple ascending dose; PK, pharmacokinetics; q.d., once daily; SAD, single ascending dose; SD, standard deviation.