Pharmacodynamics of daily subcutaneous recombinant human interleukin-3 in normal volunteers

Clin Pharmacol Ther. 1995 Jan;57(1):32-41. doi: 10.1016/0009-9236(95)90263-5.

Abstract

Normal volunteers received subcutaneous injections of recombinant human interleukin-3 (rhIL-3) on 4 consecutive days to characterize toxicity, pharmacokinetics, and hematopoietic effects. Dosages were 2.5, 5.0, and 7.5 micrograms/kg/day (n = 6 subjects per group). Adverse effects consisted predominantly of flu-like symptoms such as fever and headache. Mean area under the serum concentration-time curve and maximum serum concentration were linearly related to dose. Serum clearance was not apparently related to dose. Clearance increased slightly but significantly between days 1 and 4. Rapid but modest elevations in neutrophil and eosinophil counts were observed during treatment. Mean platelet counts rose modestly, peaking on day 10. Increases of CD34+ cell counts were correlated with increases of colony-forming unit-granulocyte macrophage (peak, day 7).

Publication types

  • Clinical Trial
  • Controlled Clinical Trial
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adult
  • Dose-Response Relationship, Drug
  • Enzyme-Linked Immunosorbent Assay
  • Half-Life
  • Headache / chemically induced
  • Hematopoiesis / drug effects
  • Humans
  • Injections, Subcutaneous
  • Interleukin-3 / administration & dosage
  • Interleukin-3 / adverse effects
  • Interleukin-3 / pharmacokinetics*
  • Male
  • Metabolic Clearance Rate
  • Recombinant Proteins
  • Stem Cells / drug effects

Substances

  • Interleukin-3
  • Recombinant Proteins