Table 1.
Subject demographics and baseline characteristics (for pharmacokinetic and safety population)
| Overall (n=40) |
37.5 IU (n=4) |
75 IU (n=12) |
150 IU (n=12) |
300 IU (n=12) |
|
|---|---|---|---|---|---|
| Race, n (%) | |||||
| Caucasian | 39 (97.5) | 4 (100) | 12 (100) | 12 (100) | 11 (91.7) |
| Hispanic | 1 (2.5) | 0 | 0 | 0 | 1 (8.3) |
| Age (years) | |||||
| Mean (SD) | 29.0 (5.4) | 28.3 (6.8) | 28.5 (5.1) | 28.3 (5.3) | 30.5 (5.8) |
| Median (range) | 28.5 (20–39) | 26.0 (23–38) | 29.0 (21–39) | 26.5 (20–37) | 31.5 (20–38) |
| Height (cm) | |||||
| Mean (SD) | 168.4 (6.5) | 172.0 (6.4) | 171.3 (5.4) | 165.8 (6.4) | 166.9 (6.6) |
| Median (range) | 169.0 (153–180) | 174.0 (163–177) | 171.0 (161–180) | 164.0 (159–179) | 169.5 (153–174) |
| Weight (kg) | |||||
| Mean (SD) | 66.4 (10.2) | 71.0 (13.5) | 69.6 (10.6) | 61.2 (5.9) | 66.8 (11.1) |
| Median (range) | 64.4 (53.1–86.7) | 72.4 (55.3–83.8) | 67.5 (55.5–84.2) | 60.4 (53.1–70.5) | 62.6 (53.9–86.7) |
| BMI (kg/m2) | |||||
| Mean (SD) | 23.4 (2.9) | 23.9 (3.6) | 23.7 (2.9) | 22.3 (2.1) | 24.0 (3.3) |
| Median (range) | 22.4 (18.9–29.0) | 23.8 (20.7–27.2) | 22.4 (20.1–28.9) | 22.1 (19.3–25.4) | 24.0 (18.9–29.0) |
Abbreviations: IU, international unit; n, number of subjects within group; SD, standard deviation; BMI, body mass index; cm, centimeter; kg, kilogram; m, meter.