TABLE 1.
Study design
| Group | n or survivor group | Targeted LD50 challenge dose | Obiltoxaximab (mg/kg, i.v.)a | Levofloxacin (mg/kg/day, p.o.) × 3 daysb | Treatment time PMC (h)c |
|---|---|---|---|---|---|
| Phase 1 (primary challenge) | |||||
| 1 | 20 | 200 | 16 | 0 (vehicle) | 30 |
| 2 | 20 | 200 | 0 (saline) | 50 | 30 |
| 3 | 20 | 200 | 16 | 50 | 30 |
| 4 | 8 | 200 | 0 (saline) | 0 (vehicle) | 30 |
| Phase 2 (rechallenge) | |||||
| 1 | Survivor group 1 (phase 1) | 200 | None | None | NA |
| 2 | Survivor group 2 (phase 1) | 200 | None | None | NA |
| 3 | Survivor group 3 (phase 1) | 200 | None | None | NA |
| 5 | 12 | 200 | None | None | NA |
a
i.v., intravenous.
b
p.o., orally.
c
PMC, post-mean challenge; NA, not applicable.