“26-Week Intravenous Injection Toxicity and Toxicokinetic Study (Seven Doses) with SelG1 in Cynomolgus Monkeys with a 4-Week Recovery Phase/8259995”
✓ VerifiedFDA multi-discipline review, p. 38Source ↗
Pivotal GLP studies
GLP cynomolgus studies: 4-week IV every 2 weeks up to 25.2 mg/kg; 26-week IV every 4 weeks up to 50 mg/kg
“Monkeys received crizanlizumab intravenously, once every 2-weeks up to 25.2 mg/kg in the 4-week study and once every 4-weeks up to 50 mg/kg in the 26-week study.”
✓ VerifiedFDA multi-discipline review, p. 30Source ↗
Route in tox
Intravenous (bolus)
“Route of administration: Intravenous (bolus) injection”
✓ VerifiedFDA multi-discipline review, p. 38Source ↗