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.
RCT Entities:
AIM: To evaluate the pharmacokinetics (PK), pharmacodynamics (PD) and primary tolerability of an anti-CD11a monoclonal antibody (CMAB001) in Chinese healthy volunteers and psoriaticpatients. 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 psoriaticpatients 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 psoriaticpatients.
Authors: Kyeong-Hee Lee; Aaron R Dinner; Chun Tu; Gabriele Campi; Subhadip Raychaudhuri; Rajat Varma; Tasha N Sims; W Richard Burack; Hui Wu; Julia Wang; Osami Kanagawa; Mary Markiewicz; Paul M Allen; Michael L Dustin; Arup K Chakraborty; Andrey S Shaw Journal: Science Date: 2003-09-25 Impact factor: 47.728
Authors: A Gottlieb; J G Krueger; R Bright; M Ling; M Lebwohl; S Kang; S Feldman; M Spellman; K Wittkowski; H D Ochs; P Jardieu; R Bauer; M White; R Dedrick; M Garovoy Journal: J Am Acad Dermatol Date: 2000-03 Impact factor: 11.527
Authors: Alice B Gottlieb; James G Krueger; Knut Wittkowski; Russell Dedrick; Patricia Ann Walicke; Marvin Garovoy Journal: Arch Dermatol Date: 2002-05