“BI 655066: A 26-Week subcutaneous toxicity and toxicokinetics study in Cynomolgus monkeys with an 8-week recovery period”
✓ VerifiedFDA multi-discipline review, p. 53Source ↗
Pivotal GLP studies
Cynomolgus monkey: 4-week IV (up to 50 mg/kg/week) or SC (20 mg/kg/week); 26-week SC up to 50 mg/kg/week
“Repeat dose toxicity of risankizumab was evaluated in a four-week study after IV administration of up to 50 mg/kg/week and at 20 mg/kg/week after SC administration, and in a 26 week chronic study with subcutaneous doses of up to 50 mg/kg/week.”
“Repeat dose toxicity of risankizumab was evaluated in a four-week study after IV administration of up to 50 mg/kg/week and at 20 mg/kg/week after SC administration”