注射用rvMIP在健康人体耐受性评价及其分析方法学初步研究.pdfVIP

rvMIP 1 rvMIP 2 ELISA rvMIP 1 24 4.0µg/kg 8.0µg/kg12.0µg/kg16.0µg/kg20.0µg/kg 25.0µg/kg 2 ELISA rvMIP 1 24 2 ELISA rvMIP 0.781ng/m0.781ng/ml~800ng/ml y=-0.1939x+1.1181 x=LogC (r==0.9923,n=6) 95.798.70 5.28%,6.16%,11.49% 7.64%,9.34%,10.85% 1 rvMIP 4.0µg/kg~25.0µg/kg 20.0µg/kg 2 ELISA rvMIP 0.781ng/ml~800ng/ml rvMIP ELISA rvMIP ABSTRACT OBJECTIVE The study was designed in 2 parts. The first part was to set up the analytic methodology; and the second part was mainly study the clinical tolerance after a single subcutaneous injection of rvMIP (4.0µg/kg25.0µg/kg) in healthy volunteers. METHODS 1. Study on clinical tolerance of rvMIP The clinical trial protocol was designed according to the Good Clinical Practice and passed by the ethics committee.It is necessary that all volunteers sign the informed consent.The 24 selecte healthy volunteers of 18~50 years old were divided into 4.0µg/kg 8.0µg/kg12.0µg/kg16.0µg/kg20.0µg/kg and 25.0µg/kg groups respectively by Latin method.Clinical symptoms were observed or examined before and after single dose intravenous infusion of recombinant viral macrophage inflammatory protein. 2. Set up the analytic methodology: An ELISA method with high precision, high particularity and sensibility were validated for rvMIP assay in serum sample. Method recovery rate and drawn recovery rate, RSD of inter-plate precision a