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Phase I Clinical Effect
2021-05-26
Tolerable safety
试验组与安慰剂组的TEAE发生率无明显差异,该研究安全性,耐受性良好。
2021-05-26
Pharmacokinetics
平均半衰期范围为129.24 h~159.14 h,表明E2HSA皮下给药后吸收和消除缓慢,可满足一周给药一次的临床需求。
2021-05-26
Pharmacodynamics
所有受试者给药后各时间点的药效指标(空腹血浆血糖、C肽、胰岛素、胰岛素原、胰高血糖素、空腹体重)与基线相比并无有临床意义的变化,各剂量组之间无明显差别,各给药组与安慰剂组相比,也无明显差别。
2021-05-26
Immunogenicity
各剂量组E2HSA给药后,只有少数受试者(约8%)产生了抗E2HSA抗体和抗Exenatide-4抗体,大部分受试者并没有产生具有中和药物活性作用的抗药抗体,提示E2HSA进入人体后引起抗药抗体可能性较低,对药效产生影响的可能性较低。