Table 1.
Summary of demographic and baseline characteristics (intent to treat population).
| Characteristic statistic | SB-121 received first (N = 7) | Placebo received first (N = 8) | Total (N = 15) |
|---|---|---|---|
| Age (years) | |||
| n | 7 | 8 | 15 |
| Mean (SD) | 20.1(1.46) | 19.9 (4.09) | 20.0 (3.05) |
| Median | 20.0 | 19.5 | 20.0 |
| Min, max | 18, 22 | 15, 27 | 15, 27 |
| Sex, n (%) | |||
| Male | 7 (100.0) | 8 (100.0) | 15 (100.0) |
| Female | 0 | 0 | 0 |
| Race, n (%) | |||
| White | 7 (100.0) | 7 (87.5) | 14 (93.3) |
| Black or African American | 0 | 0 | 0 |
| Asian | 0 | 1 (12.5) | 1 (6.7) |
| Ethnicity, n (%) | |||
| Not Hispanic or Latino | 7 (100.0) | 8 (100.0) | 15 (100.0) |
| Height (cm) at Baseline | |||
| n | 7 | 8 | 15 |
| Mean (SD) | 177.96 (6.904) | 178.54 (6.280) | 178.27 (6.343) |
| Median | 179.40 | 180.75 | 179.70 |
| Min, Max | 169.0, 189.3 | 170.3, 186.2 | 169.0, 189.3 |
| Weight (kg) at baseline | |||
| n | 7 | 8 | 15 |
| Mean (SD) | 69.67 (9.725) | 98.26 (40.006) | 84.92 (32.538) |
| Median | 69.00 | 91.15 | 75.80 |
| Min, Max | 59.0, 87.5 | 62.3, 188.9 | 59.0, 188.9 |
| Body mass index (kg/m2) at baselinea | |||
| n | 7 | 8 | 15 |
| Mean (SD) | 22.11 (3.859) | 31.29 (14.552) | 27.01 (11.606) |
| Median | 21.20 | 29.25 | 21.60 |
| Min, Max | 19.0, 30.6 | 18.0, 65.1 | 18.0, 65.1 |
ADOS-2 Autism Diagnostic Observation Schedule, 2nd edition, max maximum, min minimum, n number of participants with data available, N number of participants according to the first treatment sequence, SD standard deviation, % percentages were calculated based on N as the denominator.
Baseline was considered the last observation prior to dosing in Treatment Period 1.
Drug abuse was considered positive if at least one of the parameters of drug abuse was positive and it was considered negative if all parameters of drug abuse were negative.
aBody mass index (kg/m2) = body weight (kg)/height (m2).