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Mechanismalbumin agonists |
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Inactive Indication- |
Drug Highest PhasePhase 1 |
First Approval Ctry. / Loc.- |
First Approval Date- |
评估重组人血清白蛋白注射液在健康受试者中单次给药的安全性、耐受性及药代动力学特征的Ia期临床研究
[Translation] A phase Ia clinical study to evaluate the safety, tolerability and pharmacokinetic characteristics of a single dose of recombinant human serum albumin injection in healthy subjects
主要目的:评价重组人血清白蛋白注射液在健康受试者中的安全性和耐受性。
次要目的:评价重组人血清白蛋白注射液在健康受试者中的药代动力学(PK)特征;通过血浆胶体渗透压较基线的变化评价重组人血清白蛋白注射液在健康受试者中的药效动力学(PD)特征;评价重组人血清白蛋白在健康受试者中的免疫原性特征。
[Translation] Primary objective: To evaluate the safety and tolerability of recombinant human serum albumin injection in healthy subjects.
Secondary objectives: To evaluate the pharmacokinetic (PK) characteristics of recombinant human serum albumin injection in healthy subjects; to evaluate the pharmacodynamic (PD) characteristics of recombinant human serum albumin injection in healthy subjects by the change of plasma colloidal osmotic pressure compared with the baseline; to evaluate the immunogenicity characteristics of recombinant human serum albumin in healthy subjects.
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