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MechanismIL-17R modulators |
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Inactive Indication- |
Drug Highest PhasePhase 1 |
First Approval Ctry. / Loc.- |
First Approval Date- |
评估JLM019注射液在晚期实体瘤和淋巴瘤患者中的安全性和耐受性的Ⅰ期临床研究
[Translation] A Phase I clinical study evaluating the safety and tolerability of JLM019 injection in patients with advanced solid tumors and lymphoma.
主要目的 评价 JLM019 注射液治疗 AST 和 HL/NHL 患者的安全性和耐受性。
次要目的
初步观察 JLM019 注射液对 AST 和 HL/NHL 患者的疗效;
评价 JLM019 注射液的药代动力学特征(PK);
评价 JLM019 注射液的药效动力学特征(PD); 评估 JLM019 注射液多次给药的免疫原性;
探索与 JLM019 注射液相关的生物标志物。
[Translation] Primary Objective: To evaluate the safety and tolerability of JLM019 injection in patients with AST and HL/NHL.
Secondary Objectives: To preliminarily observe the efficacy of JLM019 injection in patients with AST and HL/NHL; to evaluate the pharmacokinetic (PK) characteristics of JLM019 injection; to evaluate the pharmacodynamic (PD) characteristics of JLM019 injection; to assess the immunogenicity of multiple-dose JLM019 injection; and to explore biomarkers associated with JLM019 injection.
评价JL18008注射液在健康成年受试者/HIV免疫重建不良患者中的药代动力学、药效动力学、安全性的随机、双盲、安慰剂对照的I/Ⅱ期临床研究
[Translation] A randomized, double-blind, placebo-controlled phase I/II clinical study to evaluate the pharmacokinetics, pharmacodynamics, and safety of JL18008 injection in healthy adult subjects/patients with poor HIV immune reconstitution
Ia期
主要目的:评价JL18008注射液在健康成年受试者中单次肌肉注射的安全性、耐受性。
次要目的:评价JL18008注射液在健康成年受试者中单次肌肉注射的药代动力学(PK)特征;初步评价JL18008注射液在健康成年受试者中单次肌肉注射的药效动力学(PD)特征;初步评价JL18008注射液在健康成年受试者中单次肌肉注射的免疫原性。
[Translation] Phase Ia
Main purpose: To evaluate the safety and tolerability of a single intramuscular injection of JL18008 injection in healthy adult subjects.
Secondary purpose: To evaluate the pharmacokinetic (PK) characteristics of a single intramuscular injection of JL18008 injection in healthy adult subjects; To preliminarily evaluate the pharmacodynamic (PD) characteristics of a single intramuscular injection of JL18008 injection in healthy adult subjects; To preliminarily evaluate the immunogenicity of a single intramuscular injection of JL18008 injection in healthy adult subjects.
JL14001注射液在健康成年受试者中单次给药、剂量递增的药代动力学、药效学、安全性、耐受性的I期临床研究
[Translation] A phase I clinical study of the pharmacokinetics, pharmacodynamics, safety and tolerability of JL14001 injection in healthy adult subjects with a single dose and increasing dose
主要目的:
评价JL14001注射液在健康成年受试者中的安全性、耐受性。 次要目的:
评价JL14001注射液在健康成年受试者中的药代动力学(PK)特征;
初步评价JL14001注射液在健康成年受试者中的药效动力学(PD)特征;
初步评价JL14001注射液在健康成年受试者中的免疫原性;
初步评估短效EPO产品-益比奥及长效EPO产品-耐斯宝分别与JL14001注射液的剂量换算关系和PD特征。
[Translation] Primary purpose:
Evaluate the safety and tolerability of JL14001 injection in healthy adult subjects. Secondary purpose:
Evaluate the pharmacokinetic (PK) characteristics of JL14001 injection in healthy adult subjects;
Preliminary evaluation of the pharmacodynamic (PD) characteristics of JL14001 injection in healthy adult subjects;
Preliminary evaluation of the immunogenicity of JL14001 injection in healthy adult subjects;
Preliminary evaluation of the dose conversion relationship and PD characteristics of the short-acting EPO product - EPIAO and the long-acting EPO product - Nicebo with JL14001 injection respectively.
100 Clinical Results associated with Jieku (Shanghai) Biomedical Research Co., Ltd.
0 Patents (Medical) associated with Jieku (Shanghai) Biomedical Research Co., Ltd.
100 Deals associated with Jieku (Shanghai) Biomedical Research Co., Ltd.
100 Translational Medicine associated with Jieku (Shanghai) Biomedical Research Co., Ltd.