Issue	Vol.21 no.11 （171-184）
Title	A phase 1 clinical study of EPOCH（epoetin beta）−A multiple subcutaneous does study−
Author	M.Tsunoo et al.

Epoetin beta (EPOCH) is recombinant human erythropoietin which regulates the number of circulating red blood cells by stimulating the maturation of erythroid progenitor cells. EPOCH has been intravenously used for anemia patients with chronic renal failure. A phase Ｉ clinical study of EPOCH was conducted in 9 healthy male adult volunteers using multiple subcutaneous doses of EPOCH 1500 IU compared to placebo. The following results on safety, pharmacokinetics and pharmacology were obtained in this study.

1) No obvious changes in subjective symptoms or side effects were observed at multiple doses.

2) Pharmacokinetic parameters did not change following multiple subcutaneous administration. It is consid]ered that multiple subcutaneous administration of EPOCH is highly safe and effective.