Table 1. Study characteristics and patients' demographics.
| Juvenile mice | Neonates and young infants | Adult healthy volunteers | |
|---|---|---|---|
| Number of subjects | 230 | 13 | 12 |
| Gender (Male / Female) | - | 7 / 6 | 12 / 0 |
| Race (Caucasian / African American) | - | 5 / 8 | |
| Dosing regimen | 6 mg/kg/day or 60 mg/kg/day | LD of 25 mg/kg followed by MD of 12 mg/kg once daily | 100 mg |
| Treatment duration | 1 – 11 days | - | Single dose |
| Administration | Subcutaneous | Intravenous | Oral |
| Current weight | 6.52 (1.80 – 10.01) g | 3.0 (1.0 – 8.0) kg | 72 kg |
| Birth weight | - | 2.7 (0.8 - 3.5) kg | - |
| Gestational age at birth | 19 days | 37 (24 - 39) weeks | - |
| Postnatal age | 9 (2 - 12) days | 19 (5 – 262) days | 24 years |
| Postmenstrual age | - | 40.9 (28.7 - 75.7) weeks | - |
| Serum creatinin concentration | - | 0.5 (0.2 - 1.3) mg/dL | - |
| Total number of samples | 60 | 94 | - |
| Number of blood samples per subject | - | 8 (4 - 8) | 15 |
Values are expressed as median (range)
LD: Loading dose; MD: maintenance dose