Pharmacodynamics of daily subcutaneous recombinant human interleukin-3 in normal volunteers.
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).
Huhn
R D
RD
Program in Clinical Pharmacology, UMDNJ-Robert Wood Johnson Medical School, New Brunswick 08903-0019.
Yurkow
E J
EJ
Kuhn
J G
JG
Clarke
L
L
Gunn
H
H
Resta
D
D
Shah
R
R
Myers
L A
LA
Seibold
J R
JR
D000328:Adult; D004305:Dose-Response Relationship, Drug; D004797:Enzyme-Linked Immunosorbent Assay; D006207:Half-Life; D006261:Headache / Q000139:chemically induced; D006410:Hematopoiesis / Q000187:drug effects; D006801:Humans; D007279:Injections, Subcutaneous; D007377:Interleukin-3 / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics*; D008297:Male; D008657:Metabolic Clearance Rate; D011994:Recombinant Proteins; D013234:Stem Cells / Q000187:drug effects
D007377:Interleukin-3; D011994:Recombinant Proteins