Table 1. Safety of oral DB844 dose regimens in un-infected vervet monkeys.
| I: DB 844 at 5 mg/kg×10 days orally | II: DB844 at 10 mg/kg×10 days orally | III: DB844 at 20 mg/kg×10 days orally | |||||
| Parameters evaluated | 572F | 582M | 541F | 578M | 543F | 606M | |
| Adverse clinical events | Reduced feed intake | None | None | Yes (11) | Yes (14) | Yes (8) | Yes (9) |
| GIT changes | None | None | None | Yes (16) | Yes (8) | Yes (8) | |
| Jaundice | None | None | None | yes | yes | yes | |
| % weight loss | 1.8 | 4.9 | 4.6 | 10.5 | 9.1 | 6.5 | |
| Daily doses completed | 10/10 | 10/10 | 10/10 | 10/10 | 8/10 | 8/10 | |
| Euthanised due to toxicity | No | No | No | Yes (16) | Yes (9) | Yes (10) | |
| Liver histology | Fatty change (Steatosis) | NA | NA | NA | +++ | +++ | +++ |
| Inflammation | NA | NA | NA | ++ | ++ | +++ | |
| Focal necrosis | NA | NA | NA | +++ | +++ | +++ | |
| Haemosiderosis | NA | NA | NA | ++ | + | +++ | |
| GIT histology | Ulcers/erosions | NA | NA | NA | +++ | +++ | +++ |
| Inflammation | NA | NA | NA | +++ | +++ | +++ | |
| Haemosiderosis | NA | NA | NA | ++ | + | +++ | |
| Spleen histology | Expanded red pulp | NA | NA | NA | +++ | ++ | ++ |
| Haemosiderosis | NA | NA | NA | +++ | +++ | +++ | |
| Kidney histology | Hydropic degeneration/interstitial oedema | NA | NA | NA | +++ | + | + |
Key: GIT = gastrointestinal system; numbers in parenthesis = time in days post first drug dose when an adverse clinical event was observed; NA = not assessed since the monkeys were not euthanized; F = female; M = male.