Table 1.
Study (-Phase) | n Animals (M/F) | Dose(s) (mg/kg IV, mg IT) | Samples/Data Collected | Time Points | Analysis Methods |
---|---|---|---|---|---|
A-1 | 6 animals (3M/4F) | 1.5 mg/kg IV | Blood, CSF | 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 8 h, 1 day, 2 days, 3 days post dose | ELISA |
A-1 | 6 animals per dose (3M/4F) | 1.5 mg, 4.5 mg, 13.5 mg IT | Blood, CSF | 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 8 h, 1 day, 2 days, 3 days post dose | ELISA |
A-2 | 2 animals per time point (1M/1F) | 14.5 mg IT | Blood, CSF, Tissues | predose and 1 h, 4 h, 8 h, 1 day, 3 days, 7 days post dose | ELISA, enzyme activity |
B | 4 animals (2M/2F) | 1 mg/kg IV | Blood, whole body PET | t = 0 and every 30 min 1–5 h, then at 1 day and 2 days | Radioactivity HPLC, PET |
B | 4 animals (2M/2F) | 3 mg IT | Blood, whole body PET | t = 0 and every 30 min 1–5 h, then at 1 day and 2 days | Radioactivity HPLC, PET |
Intravenous (IV); intrathecal (IT); cerebral spinal fluid (CSF); enzyme linked immunosorbent assay (ELISA); high performance liquid chromatography (HPLC), positron emission tomography (PET).