The effect of Y-25510 injection on the serum levels of some cytokines in healthy adult volunteers

Abstract

Objective: Y-25510 was administered by means of an intravenous drip infusion to healthy adult male volunteers at a dose of 40, 80 or 160 mg in a single-dose study, and at a dose of 160 mg once a day for 7 days in a multiple-dose study.

Results: Serum levels of interleukin (IL)-1β, IL-6 and IL-10 were significantly increased, but there was no change in leukocyte and platelet counts. The peak serum concentration of IL-1β was nearly maximum at the single doses of 40 and 80 mg, and at the multiple dose of 160 mg per day. The peak serum concentration of IL-6 increased in a dose-dependent manner at a dose of 40 mg or more. For the multiple-dose study, the serum level of IL-10, which remained unchanged in the placebo group, began to increase in the Y-25510 group following the maximum serum level of IL-1β and IL-6. There were no clinically relevant differences in body temperature and blood pressure after the administration of Y-25510.

Conclusion: These findings that leukocyte and platelet counts never increased, despite the increment of the IL-1β and IL-6 production after the administration of Y-25510, may be explained in part by the negative feedback mechanism induced by IL-10.