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[Translation] Phase 1 clinical trial of PEG30-rhG-CSFI
选择肿瘤化疗后预计将出现3度和/或4度粒细胞减少症的病人,进行受试药PEG30-rhG-CSF的临床I期剂量爬坡试验,考察人体对受试药的反应、耐受性和初步疗效,探索受试药在肿瘤化疗病人药代动力学和药效动力学的特征;为受试药临床II期试验方案提供给药剂量和用法的依据。
[Translation] Patients who are expected to develop grade 3 and/or grade 4 granulocytopenia after tumor chemotherapy are selected for a Phase I dose-escalation trial of the test drug PEG30-rhG-CSF to examine the body's response, tolerance and preliminary efficacy to the test drug, and to explore the pharmacokinetic and pharmacodynamic characteristics of the test drug in patients undergoing tumor chemotherapy; this will provide a basis for dosing and usage for the Phase II clinical trial plan of the test drug.
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