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Recombinant Human Serum Albumin in Healthy Subjects

Beijing Protgen Biotechnology Development Co., Ltd. · 2021
ClinicalTrials.gov · Datasets · License: Public Domain · 2021
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This trial adopts a single-center, randomized, double-blind, dose-escalation, placebo-controlled design to evaluate the safety, tolerability, pharmacokinetics, and efficacy of a single administration of recombinant human serum albumin in healthy subjects Kinetics and anti-drug antibody characteristics. Qualified healthy subjects (both male and female) were screened and enrolled to the four dose levels of 2 g, 5 g, 10 g, and 20 g according to the principle of dose escalation, and 6 out of 8 subjects in each dose group One patient received the test drug, and two received a placebo.
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