“Slow bolus intravenous injection via a saphenous vein once weekly for 13 weeks (14 doses) at a dose volume of 2 mL/kg.”
✓ VerifiedFDA multi-discipline review, p. 48Source ↗
Pivotal GLP studies
GLP 4-week and 13-week repeat-dose studies in cynomolgus monkeys, once-weekly IV slow bolus, 10-week recovery for 13-week study
“CK-301: Once Weekly Intravenous Slow Bolus Injection Toxicity and Toxicokinetic Study in Cynomolgus Monkeys for 13 Weeks with a 10-Week Recovery Phase”
✓ VerifiedFDA multi-discipline review, p. 55Source ↗
Route in tox
Intravenous (slow bolus)
“Species/Strain: Macaca fascicularis Method of Administration: Intravenous Bolus Injection”
✓ VerifiedFDA multi-discipline review, p. 51Source ↗