Imaavy: how was the first human dose set?

“In the SAD portion of the study, six groups received a single IV infusion of placebo (N=10) or escalating doses of nipocalimab at 0.3 mg/kg (N=3), 3 mg/kg (N=3), 10 mg/kg (N=6), 30 mg/kg (N=6), or 60 mg/kg (N=6).”

“As nipocalimab cannot be ruled out as involved in the mechanism of systemic lymphoproliferation in the euthanised monkey in the 26-week study, the NOAEL should be lowered to 100 mg/kg providing safety margins of 10.8 and 6.7 based on AUC0-last and Cmax, respectively.”