Table 1.
Study Design
| Group | 5A Peptidea Dose (mg/kg/dose) | Fx-5A Dose Volumed (mL/kg)c | Number of NHPs at Study start (M+F) | Terminal Necropsy (M+F) | |
|---|---|---|---|---|---|
| Day 29 | Day 42 | ||||
| 1 | 0 | 5.000b | 10 (5+5) | 6 (3+3) | 4 (2+2) |
| 2 | 8 | 0.533 | 10 (5+5) | 6 (3+3) | 4 (2+2) |
| 3 | 25 | 1.667 | 10 (5+5) | 6 (3+3) | 4 (2+2) |
| 4 | 75 | 5.000 | 10 (5+5) | 6 (3+3) | 4 (2+2) |
a
dose is expressed in 5A peptide equivalent.
b
Volume of vehicle (20mM sodium phosphate, pH 5.1) injected
c
The actual dose volume (mL/kg) administered to each monkey was based on that animal’s most recent body weight
d
[peptide 5A (15 mg/mL) with egg sphingomyelin (ESM) (21.50 mg/mL)].