Table 1.

AMG 139 treatments and procedures for studies in cynomolgus monkeys

Study	n	Groups	Treatment	Sample collection for PK
Single dose	6 males	2 animals per group	3 mg·kg−1 i.v. 3 mg·kg−1 s.c. 8.63 mg·kg−1 s.c. Single dose	Samples were collected pre-dose and at 1, 4, 8, 24, 72, 96, 120, 168, 240, 336, 504, 840 and 1176 h post-dose; an additional sample at 0.25 h was collected for the i.v. group
14-day GLP	16 males 16 females	3–5 animals per group per sex	Vehicle control s.c. 30 mg·kg−1 s.c. 100 mg·kg−1 s.c. 300 mg·kg−1 s.c. QW for 2 weeks	Blood samples were collected pre-dose and at 4, 24, 48, 72 and 168 h post-dose on study days 1 and 8 of the dosing phase; the pre-dose sample collected prior to the second dose on day 8 is equivalent to 168 h post-dose for day 1. Blood samples from recovery monkeys (two monkeys from vehicle control and 300 mg·kg−1 group) were collected on study days 28, 56, 84 and 98 days
3-month GLP	26 males 26 females	4–6 animals per group per sex	Vehicle control s.c. and i.v. 30 mg·kg−1 s.c. 100 mg·kg−1 s.c. 300 mg·kg−1 s.c. 300 mg·kg−1 i.v. QW for 13 weeks	Serum samples were collected pre-dose and 0.5, 4, 24, 48, 72 and 168 h post-dose on study days 1 and 92. In addition, samples were collected from animals pre-dose on study days 15, 29 and 57. Blood samples from recovery monkeys (two monkeys per sex from vehicle control and the 300 mg·kg−1 dose groups) were collected on study days 126, 154, 182, 210, 238, 266, 295, 322, 350, 378, 406, 434 and 462.
6-month GLP	20 males 20 females	4–6 animals per group per sex	Vehicle control s.c. 30 mg·kg−1 s.c. 100 mg·kg−1 s.c. 300 mg·kg−1 s.c. QW for 26 weeks	Serum samples were collected pre-dose and at approximately 0.5, 4, 24, 48, 72 and 168 h post-dose on study days 1 and 176. In addition, blood samples were collected pre-dose and at 48 h post-dose on study days 29, 57, 92 and 134. Blood samples from recovery animals (2/sex/group) were collected on study day 211.

PK, pharmacokinetics; QW, once-weekly.