“In toxicology studies up to 6 months duration, no target organs of toxicity were identified in either mice or monkeys at an IV dose up to 25 mg/kg once every 4 weeks.”
✓ VerifiedFDA pharmacology/toxicology review, p. 2Source ↗
Pivotal GLP studies
6-month IV studies in mice and cynomolgus monkeys, up to 25 mg/kg once every 4 weeks
“In toxicology studies up to 6 months duration, no target organs of toxicity were identified in either mice or monkeys at an IV dose up to 25 mg/kg once every 4 weeks.”
✓ VerifiedFDA pharmacology/toxicology review, p. 2Source ↗
Route in tox
IV
“Repeat-dose GLP toxicology studies were conducted in CD-1 mice, CByB6F1- Tg(HRAS)2Jic mice, and cynomolgus monkeys using the IV route of administration.”
✓ VerifiedFDA pharmacology/toxicology review, p. 48Source ↗