Pharmacokinetic and pharmacodynamic study of LFA3Ig fusion protein in healthy volunteers and patients with psoriasis

Acta Pharmacologica Sinica
Xian-ping LiYa-Jun Guo

Abstract

To evaluate the pharmacokinetics (PK) and pharmacodynamics of the LFA3Ig fusion protein (LFA3IgFP) in healthy volunteers and patients with chronic plaque psoriasis. The clinical trials included 2 phase I open studies. Study 1 was an open-label dose escalation study in 24 healthy volunteers, and study 2 was a single-group, open-label study in 12 patients with chronic plaque psoriasis. The serum drug concentrations were measured, and the concentration-time data were analyzed by compartmental analysis using the Practical Pharmacokinetic Program. In study 1, after intramuscular (im) administration at a dosage of 5, 15, and 25 mg, the concentration-time curves of LFA3IgFP fitted well to a 1 compartment open model. Areas under the concentration-time curves increased linearly with dose. Clearance rates (Cls/ F) and elimination half-lives (T1/2ke) had no significant difference between different dose groups. A transient, slight decline of CD(4+) and CD(8+) T-cell subsets was observed after administration. In study 2, after im administration at a dosage of 15 mg weekly for 8 weeks, the concentration-time curve was best fitted to a 1 compartment open model, with a T(1/2ke ) of 307.9+/-32.7 h. The steady state was attained after the fifth ...Continue Reading

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Citations

Sep 12, 2006·Journal of Ethnopharmacology·Ilkay OrhanErdem Yesilada

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