[Translation] Phase Ia clinical trial of tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single dose-escalating fusion protein of recombinant human serum albumin for injection and interferon α-2b in healthy adult volunteers
主要目的:评估注射用重组人血清白蛋白与干扰素α-2b融合蛋白单次给药在健康成年志愿者中的安全性; 评估注射用重组人血清白蛋白与干扰素α-2b融合蛋白单次给药在健康成年志愿者中的耐受性;
次要目的:评估注射用重组人血清白蛋白与干扰素α-2b融合蛋白单次给药在健康成年志愿者中的药代动力学(PK)特征。 评估注射用重组人血清白蛋白与干扰素α-2b融合蛋白单次给药在健康成年志愿者中的药效学(PD)特征。 评估注射用重组人血清白蛋白与干扰素α-2b融合蛋白单次给药在健康成年志愿者中的免疫原性特征。
[Translation] Primary objective: To evaluate the safety of a single administration of recombinant human serum albumin and interferon α-2b fusion protein for injection in healthy adult volunteers; To evaluate the tolerability of a single administration of recombinant human serum albumin and interferon α-2b fusion protein for injection in healthy adult volunteers;
Secondary objective: To evaluate the pharmacokinetic (PK) characteristics of a single administration of recombinant human serum albumin and interferon α-2b fusion protein for injection in healthy adult volunteers. To evaluate the pharmacodynamic (PD) characteristics of a single administration of recombinant human serum albumin and interferon α-2b fusion protein for injection in healthy adult volunteers. To evaluate the immunogenicity characteristics of a single administration of recombinant human serum albumin and interferon α-2b fusion protein for injection in healthy adult volunteers.