Single ascending dose (SAD)

Subjects in a SAD study receive only one dose of the study drug.

A SAD study is a type of phase 1 trial which is almost always performed first in order to obtain a rough understanding of a drug’s single dose pharmacokinetics and the safe dose range. It is recommended to dose subjects sequentially with an appropriate period of observation between dosing of individual subjects.

For SAD studies, the starting dose is based on the pre-clinical and animal studies. For MAD studies, the starting dose is usually based on results from the SAD study.

See also: multiple ascending dose (MAD)