Exdensur: how was the first human dose set?

The public FDA and EMA reviews of Exdensur don't say how the first human dose was chosen. That rationale is in the IND, which is confidential, so it is missing for most approved products.

Find the highest dose with no adverse effects (NOAEL) in each animal species, convert it to a human equivalent dose, usually by body surface area, pick the most appropriate species, then divide by a safety factor (default 10) to get the maximum recommended starting dose.

NOAEL / key findings: NOAEL 10 mg/kg (EMA, QTc at 100 mg/kg) or 100 mg/kg (applicant); reduced eosinophils; vasculitis in single-dose study (EMA assessment report, p. 55)

Full method, every step sourced →