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Clinical Trials associated with LP001(LintonPharm)评价LP-001注射液在健康受试者中单次及多次注射给药的安全性、耐受性和药代动力学的 I 期临床研究
[Translation] Phase I clinical study to evaluate the safety, tolerability and pharmacokinetics of LP-001 injection after single and multiple injections in healthy subjects
主要目的:评价健康受试者单次/多次皮下注射不同剂量的LP-001的剂量耐受性和安全性;
次要目的:1)评价健康受试者单次/多次注射不同剂量LP-001注射液的药代动力学特征;2)评价健康受试者单次/多次注射不同剂量LP-001注射液的免疫原性;3)评价健康受试者单次/多次注射不同剂量LP-001注射液的药效学特征。
探索性目的及评价指标:探索分析健康受试者单次及多次注射不同剂量LP-001注射液后的PK/PD相关性。
[Translation] Primary objective: To evaluate the dose tolerance and safety of single/multiple subcutaneous injections of different doses of LP-001 in healthy subjects;
Secondary objectives: 1) To evaluate the pharmacokinetic characteristics of single/multiple injections of different doses of LP-001 injection in healthy subjects; 2) To evaluate the immunogenicity of single/multiple injections of different doses of LP-001 injection in healthy subjects; 3) To evaluate the pharmacodynamic characteristics of single/multiple injections of different doses of LP-001 injection in healthy subjects.
Exploratory objectives and evaluation indicators: To explore and analyze the PK/PD correlation after single and multiple injections of different doses of LP-001 injection in healthy subjects.
100 Clinical Results associated with LP001(LintonPharm)
100 Translational Medicine associated with LP001(LintonPharm)
100 Patents (Medical) associated with LP001(LintonPharm)
100 Deals associated with LP001(LintonPharm)