%0 Journal Article %T Pharmacokinetic and pharmacodynamic study of LFA3Ig fusion protein in healthy volunteers and patients with psoriasis %A Li Xian-ping %A Li Jing %A Yan Heng %A Hou Sheng %A Qian Wei-zhu %A Chen Yong-chuan %A Tang Min %A Li Bo-hua %A Zhang Da-peng %A Zhou Bo %A Wang Hao %A Hao Fei %A Guo Ya-jun %J Acta Pharmacologica Sinica %D 2016 %B 2016 %9 %! Pharmacokinetic and pharmacodynamic study of LFA3Ig fusion protein in healthy volunteers and patients with psoriasis %K %X Aim: To evaluate the pharmacokinetics (PK) and pharmacodynamics of the LFA3Ig fusion protein (LFA3IgFP) in healthy volunteers and patients with chronic plaque psoriasis. Methods: 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. Results: 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 ( T 1/2ke ) had no significant difference between different dose groups. A transient, slight decline of CD4 + and CD8 + 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 administration. Conclusion: The PK behaviors of LFA3IgFP in healthy volunteers and patients with chronic plaque psoriasis complied with linear kinetics within the examined dose range. A significant accumulation was observed after repeated administration at a dose of 15 mg weekly for 8 weeks. %U http://www.chinaphar.com/article/view/6129 %V 29 %N 9 %P 1077-1085 %@ 1745-7254