Tolerability, pharmacokinetics and pharmacodynamics of CMAB001, an anti-CD11a antibody, in Chinese healthy volunteers and psoriatic patients

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.

Comparison of disease‐modifying anti‐rheumatic drugs and hyperbaric oxygen therapy in the experimental model of rheumatoid arthritis in rats

“…In the last decade, new therapeutics and effective treatment strategies have reduced long‐term damage and functional decline 1 . Leflunomide and etanercept are two distinct treatment options for RA; leflunomide, an oral disease‐modifying anti‐rheumatic drug (DMARD), inhibits pyrimidine synthesis through dihydroorotate dehydrogenase, 2 improving RA patients' function and quality of life. However, it can cause side effects like elevated alanine aminotransferase, gastrointestinal symptoms and increased leukocyte counts, particularly in high‐risk individuals within 6 months 3,4 .…”

Longitudinal polarization stability of near-elliptic inner-cladding polarization-maintaining photonic crystal fiber

“…High birefringence can be induced by breaking the 60°s ymmetry of the triangular lattice PCFs such as omitting two of adjacent air holes, enlarging two of the central air holes, introducing twofold rotational symmetries with two different hole sizes and so on [5,6]. High-birefringence PCF such as near Panda clading photonic crystal fiber (NPC-PCF) and near rectangle photonic crystal fiber (NR-PCF) shows a great potential application in polarization dependence modulator and optical fiber sensor such as fiber optic gyroscope [7,8].…”