PHARMACOKINETICS OF RECOMBINANT HUMAN INTERLEUKIN-11 (RHIL-11) IN HEALTHY MALE-SUBJECTS

Aims To study the pharmacokinetics of recombinant human interleukin-11 (rhIL-11) in healthy male volunteers following subcutaneous (s.c.) an d intravenous (i.v.) administration. Methods RHIL-11 was infused intra venously at 10-50 mu g kg(-1) for 1 or 3 h, or adminstered subcutaneou sly at 3-50 mu g kg(-1) to volunteers. RhIL-11 ws also adminstered at 3 mu g kg(-1) s.c. once daily fo 7 days. Plasma and urinary concentrat ions were measured by enzyme-linked immunosorbent assay (ELISA). Resul ts RhIL-11 showed linear pharmacokinetics after both intravenous infus ion and s.c. administration. Comparison of t(1/2) and MRT values after i.v. administration with those after s.c. administration indicated th at rhIL-11 pharmacokinetics after s.c. administration were absorption rate-limited. Bioavailability after s.c. administration was about 65%. Since RHIL-11 was not detected in urine after a single 50 mu g kg(-1) s.c. dose, rhIL-11 was considered to be eliminated by metabolism. The re was no significant change in the pharmacokinetic profile of rhIL-11 following repeated s.c. administration. Conclusions RhIL-11 demonstra ted linear pharmacokinetics at these dose ranges after single and repe ated s.c. administration or constant-rate i.v. infusion in healthy vol unteers.