Sarclisa: how was the first human dose set?

“Based on the overall data, the recommended starting human dose for the first-in-human study was 0.0001 mg/kg, which is approximately 10% of the predicted CD38 receptor occupancy measured in normal human B and T cells.”

“Therefore, under these study conditions, the dose of 100 mg/kg/week was considered to be the no-observed adverse effect level (NOAEL)”