“Safety pharmacology parameters were included in the 6- and 39-week intravenous and/or 13-week subcutaneous repeat-dose toxicology studies in cynomolgus monkeys.”
✓ VerifiedFDA multi-discipline review, p. 50Source ↗
Pivotal GLP studies
GLP cynomolgus monkey repeat-dose studies of 6 weeks, 13 weeks and 9 months
“GLP-compliant repeat-dose studies of 6 weeks, 13 weeks and 9 months in duration were conducted in cynomolgus monkeys to evaluate the toxicity and TK of lebrikizumab.”