“There were no clear drug-related adverse effects in the GLP 6-month study of ch12F6A (0, 10, 40, or 250 mg/kg/week IV) or aducanumab (250 mg/kg/week IV) in aged Tg2576 mice.”
✓ VerifiedFDA pharmacology/toxicology review, p. 48Source ↗
Pivotal GLP studies
Chronic Tg2576 mouse study with murine analog ch12F6A; 4-week monkey and 13-week Tg2576 mouse studies
“toxicity of the murine analog (ch12F6A) was tested in the Tg2576 mouse; shorter-duration toxicity studies were conducted in monkey (4-week) and Tg2576 mouse (13-week).”
✓ VerifiedFDA pharmacology/toxicology review, p. 3Source ↗
Route in tox
IV (weekly slow bolus)
“In Tg2576 mouse, ch12F6A was administered for 13 weeks (0, 10, 70, or 500 mg/kg) or 6 months (0, 10, 40, or 250 mg/kg) weekly by intravenous injection”
✓ VerifiedFDA pharmacology/toxicology review, p. 3Source ↗