Performed a phase I study
Smooth Drug Development has performed a phase I study with a erythropoiesis stimulating agent in healthy volunteers.
Phase I studies are conducted when the drug has shown efficacy and safety studies in vitro and in vivo. Usually the studies are conducted in healthy volunteers, however, toxic and biological drugs are tested in patients with diseases. In phase I safety, tolerability, pharmacokinetic and pharmacodynamic are tested. Sometimes these are divided into research phase Ia and Ib according to the primary target.