注射用重组人胸腺肽α1人体耐受性临床研究

摘要

目的 观察健康人体对注射用重组人胸腺肽α1皮下注射的耐受性与安全性,采用剂量递增方案,确定单次及连续给药的安全剂量范围.方法 单次给药48例健康受试者入组试验,其中36例分别皮下注射0.3 mg/m2、0.6 mg/m2、0.9 mg/m2、1.4 mg/m2、2.0 mg/m2、2.7 mg/m2注射用重组人胸腺肽α1,12例注射相应剂量的注射用水作为安慰剂;连续给药12例健康受试者分别皮下注射2.0 mg/m2、2.7 mg/m2注射用重组人胸腺肽α1,每周给药2次,连续4周.用药后对受试者进行临床观察和实验室检查,评价试验药物在人体的安全性.结果 单次给药48例健康受试者入组并完成试验,所有受试者均未出现不良事件.连续给药12例健康受试者入组并完成试验,其中,有5名受试者出现不良事件,其中3例出现大便潜血阳性,1例出现血红蛋白尿,1例受试者出现大便潜血阳性和血红蛋白尿.停药后于随访期复查恢复正常,均无特殊处理,自行好转.结论 单次应用注射用重组人胸腺肽α10.3～2.7 mg/m2是安全的,耐受性良好;连续使用4周,每周2次,剂量在2.7 mg/m2内是基本安全的.%Objective To evaluate the safety,tolerance and make sure the safe dose range of single dose and continuous hypodermic injection Recombinant Human Thymosin Alpha?1(rh?thymosinα1)in Chinese healthy volunteers. Methods 48 healthy volunteers were received a single dose group ,including 36 subjects hypodermic injection of 0.3 mg/m2,0.6 mg/m2,0.9 mg/m2,1.4 mg/m2,2.0 mg/m2,2.7 mg/m2 rh?thymosinα1,12 subjects hypodermic injection of the same dose water as placebo. 12 subjects in continuous dose group were hypodermic injected 2.0 mg/m2 or 2.7 mg/m2 rh?thymosinα1,two times a week,continue for four weeks. Safety and tolerance were evaluated by monitoring adverse events and laboratory parameters. Results 48 healthy volunteers actual finished in a single dose group. There were no adverse events taken place in a single dose group. 12 healthy volunteers actual finished in a continuous dose group. There were 5 adverse events taken place in a continuous dose group ,including 3 subjects fecal occult blood(FOB),1 subject haemoglobinuria,1 subject FOB and haemoglobinuria. All of them returned to normal after drug withdrawal in follow?up phase. Conclusion Rh?thymosinα1 from 0.3 mg/m2 to 2.7 mg/m2 hypodermic injection of single dose was safe and well tolerance. Continuous using for four weeks ,two times a week and the dose in 2.7 mg/m2 were safe.