Tolerance and safety study of recombinant human cytotoxic T lymphocyte associate antigen-4 fusion protein for injection at multiple dose
WANG Jing
WU Yin
JIA Yan-yan
WEN Ai-dong
Abstract：Obiective: To evaluate the tolerance and safety of recombinant human cytotoxic associate anti-sen-4 fusion protein(rhCTLA4-Ig) , in rheumatoid arthritis patients and to provide recommendins dose for phase Ⅱ clinical trial. Methods:Nine rheumatoid arthritis patients were treated with rhCTLA4-Is by intravenous drip infusion with a dose of 10 mg·kg~(-1) rhCTLA4-Ig at 0, 2, 4, 8, 12 and 16 weeks. The safety was assessed based on clinical symptoms before and after subcutaneous injection. Results: No serious adverse reaction was observed during the study. There was no evidence of liver or kidney impairment or toxic reactions in digestive and cardiovascular sys-tems. Conclusion:It was safe and tolerable for rheumatoid arthritis patients to receive intravenously infused rhCT-LA4-Ig at multiple dose of 10 mg·kg~(-1). The recommended dose for phase Ⅱ clinical trial is 10 mg. Kg~(-1) at 0, 2, 4, 8, 12 and 16 week.
Keywords：recombinant human cytotoxic T lymphocyte associate antigen-4 fusion protein(rhCTLA4-Ig)phase Ⅰ clinical studytolerance
Publication Date：2010-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：4( 210-213 )