Tolerability, Pharmacokinetics and Pharmacodynamics of CMAB001, an Anti-CD11a Antibody, in Chinese Healthy Volunteers and Psoriatic Patients

Overview

Journal Acta Pharmacol Sin

Specialty Pharmacology

Date 2012 Jul 17

PMID 22796761

Authors

Xian-Ping Li

Jing Li

Heng Yan

Bo Zhou

Bo-Hua Li

Wei-Zhu Qian

Sheng Hou

Hao Wang

Fei Hao

Ya-Jun Guo

Affiliations

Soon will be listed here.

Abstract

Aim: To evaluate the pharmacokinetics (PK), pharmacodynamics (PD) and primary tolerability of an anti-CD11a monoclonal antibody (CMAB001) in Chinese healthy volunteers and psoriatic patients.

Methods: Two open-label studies were conducted. One was a parallel-group, single-center, dose-escalation test, including 24 healthy adult volunteers from 18 to 45 years in age. All subjects randomly received a single subcutaneous injection dose of 0.5, 1.0 or 2.0 mg/kg. The other was a multiple-dose study: 10 adult psoriatic patients were administered weekly subcutaneous injections of 1.0 mg/kg for 7 weeks.

Results: CMAB001 was well tolerated in the single- and multiple-dose studies. Slow absorption was observed in both studies. In the single-dose study, the concentration of CMAB001 reached its highest level 2 d later after the injection, and the C(max) increased in an approximate dose-proportionate manner, while the area under curve (AUC) showed much greater than dose-proportionate increase. In the multiple-dose study, the steady-state serum concentration level was attained following the 4th injection.

Conclusion: CMAB001 exhibited a nonlinear pharmacokinetic profile over the dose range from 0.5 to 2.0 mg/kg, and was well tolerated in healthy volunteers and psoriatic patients.

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