Delving into the Latest Updates on Recombinant human albumin (Shandong Kingtone) with Synapse

Overview

Basic Info

Drug Type

Recombinant protein

Synonyms-

Target

albumin

Mechanism

albumin agonists(Serum albumin agonists)

Therapeutic Areas

Hemic and Lymphatic Diseases

Active Indication

Hypoalbuminemia

Inactive Indication-

Originator Organization

Shandong Kingtone Biotechnology Co., Ltd.

Active Organization

Shandong Kingtone Biotechnology Co., Ltd.

Inactive Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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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.

Start Date01 Mar 2024

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