Group | Number M/F | Dose (mg/kg, s.c.)a | Dose Regimena | Number of Animals Sacrificed (M/F) | ||
---|---|---|---|---|---|---|
Interim (Day 93) | Terminal (Day 275) | Recovery (Day 455) | ||||
Monkeys, main study | ||||||
1 | 9/9 | 0 | biw/q1w | 3/3 | 4/4 | 2/2 |
2 | 7/7 | 2 | biw/q1w | 3/3 | 4/4 | |
3 | 7/7 | 6 | biw/q1w | 3/3 | 4/4 | |
4 | 9/9 | 12 | biw/q1w | 3/3 | 4/4 | 2/2 |
5 | 5/5 | 30 | biw/q1w | 3/3 | — | 2/2b |
Monkeys, toxicokinetics | ||||||
6 | 7/7 | 2 | biw for 2 wk | 1/sex/interval on days 3, 16, 23, 30, 37, 51, and 72 |
F, female; M, male.
↵a ISIS 702843 was administered by subcutaneous injection twice per week (biw) for the first 2 wk (days 1, 5, 9, and 14) and then once weekly (q1w) for the remainder of the study.
↵b Group 5 recovery animals were sacrificed after a 6-mo recovery period on the same day as the terminal animals from groups 1 to 4 (study day 275, recovery day 184).