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Clinical Trials associated with LP001(LintonPharm) / Not yet recruitingPhase 1 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.
/ Active, not recruitingPhase 1 A Phase I Clinical Study Evaluating the Safety, Tolerability, and Pharmacokinetics of LP-001 Injection in Healthy Subjects Following Single and Multiple Doses
The purpose of this study is to evaluate safety, tolerability, immunogenicity, pharmacokinetics, pharmacodynamics, and efficacy of LP-001 in healthy volunteers. The study will be conducted in 2 parts: Part 1, the single ascending dose (SAD) is the first in human (FIH) study of LP-001 and Part 2, multiple ascending dose (MAD).
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)