Single ascending dose study [SAD]

A single ascending dose study (SAD study) is a type of Phase I trial. Single ascending dose studies are usually conducted in a small number of healthy volunteers (although some trials recruit patients). The aim is to find out the safe dose range, and to look for any side effects. The initial dose given will be very small and increased gradually (in a new group of volunteers) if no or only mild side effects are seen. Researchers will also take measurements to determine how the medicine is processed in the body.

Making a medicine. Step 6: Phase I – Proof of mechanism
Phase I clinical studies, or proof of mechanism studies, test the safety of a medicine in humans. Usually, these studies are carried out in healthy human volunteers.
Types of Study in Early Clinical Development
Early clinical trials (Phase I and II) must establish above all that an investigational medicinal product is safe for humans, as well as to show that the medicine is effective against the intended disease or condition.

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Single ascending dose study [SAD]

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