“Once weekly subcutaneous injections of ixekizumab for 9 months in cynomolgus monkeys caused no adverse compound-related clinical signs at ≤5 mg/kg/week.”
✓ VerifiedFDA pharmacology/toxicology review, p. 19Source ↗
Pivotal GLP studies
GLP cynomolgus monkey studies: up to 8-week weekly IV and 39-week weekly SC, with recovery groups
“General toxicity studies used intravenous dosing for up to 8 weeks and subcutaneous dosing up to 39 weeks with recovery groups for high dose and controls.”
“General toxicity studies used intravenous dosing for up to 8 weeks and subcutaneous dosing up to 39 weeks with recovery groups for high dose and controls.”