“The Sponsor conducted oral toxicology studies up to 26 weeks in rats, 13 weeks in hamsters, and 44 weeks in monkeys.”
✓ VerifiedFDA multi-discipline review, p. 383Source ↗
Why that species
Hamster and monkey pharmacologically relevant (on- and off-target toxicity); rat not pharmacologically relevant, off-target toxicity only
“The hamster and monkey were pharmacologically relevant species and could assess both potential on-target and off-target toxicity. However, the rat was not a pharmacologically relevant and could only assess potential off-target toxicity.”
✓ VerifiedFDA multi-discipline review, p. 383Source ↗
Surrogate molecule
No surrogate; the clinical compound was tested
“In the 13-week toxicology study in hamster, CCX168 was administered at doses of 0 (vehicle), 10, 30, 100 and 1000 (500 mg/kg BID) mg/kg/day.”
✓ VerifiedFDA multi-discipline review, p. 383Source ↗