“Five-week SC and IV and 24-week SC toxicology studies were conducted in young adult to adult cynomolgus monkeys administered guselkumab SC at doses of 10 or 50 mg/kg, once per week for 5 or 24 weeks”
✓ VerifiedFDA multi-discipline review, p. 65Source ↗
Pivotal GLP studies
Cynomolgus monkey study: weekly IV/SC for 5 weeks (phase 1) or SC for 24 weeks (phase 2), up to 50 mg/kg
“Once weekly administration of guselkumab via the IV and SC route for 5 weeks (phase 1) or SC 24 weeks (phase 2) up to 50 mg/kg”