2
Clinical Trials associated with LIN-2102 / Not yet recruitingPhase 1 A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose and Multiple Dose Study of SLN12140 Administered Subcutaneously or Intravenously in Healthy Adult Volunteers
A randomized, double-blind, placebo-controlled phase I clinical study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of SLN12140 in healthy participants with single subcutaneous/intravenous dose escalation and multiple subcutaneous administrations
/ Not yet recruitingPhase 2 一项评估SLN12140在补体抑制剂初治成人阵发性睡眠性血红蛋白尿症受试者的II期临床研究
[Translation] A phase II clinical study evaluating SLN12140 in adult patients with complement inhibitor-naïve paroxysmal nocturnal hemoglobinuria.
主要目的:评估PNH受试者接受SLN12140皮下注射后的初步有效性
次要目的:评估PNH受试者接受SLN12140皮下注射后的其他有效性指标、评估PNH受试者接受SLN12140皮下注射后的安全性及耐受性、评估PNH受试者接受SLN12140皮下注射后的药代动力学(PK)特征、评估PNH受试者接受SLN12140皮下注射后的药效动力学(PD)特征、评估PNH受试者接受SLN12140皮下注射后的免疫原性
探索性目的:在数据允许的情况下,初步建立SLN12140的群体药代动力学(Pop-PK)模型,获取群体PK参数,同时初步探索可能影响个体PK参数的协变量和暴露-效应(E-R)关系
[Translation] Primary Objective: To evaluate the preliminary efficacy of SLN12140 in PNH subjects after subcutaneous injection.
Secondary Objectives: To evaluate other efficacy endpoints of SLN12140 in PNH subjects after subcutaneous injection; to evaluate the safety and tolerability of SLN12140 in PNH subjects after subcutaneous injection; to evaluate the pharmacokinetic (PK) characteristics of SLN12140 in PNH subjects after subcutaneous injection; to evaluate the pharmacodynamic (PD) characteristics of SLN12140 in PNH subjects after subcutaneous injection; to evaluate the immunogenicity of SLN12140 in PNH subjects after subcutaneous injection.
Exploratory Objective: Where data permits, to preliminarily establish a population pharmacokinetic (Pop-PK) model of SLN12140, obtain population PK parameters, and preliminarily explore covariates and exposure-response (E-R) relationships that may affect individual PK parameters.
100 Clinical Results associated with LIN-2102
100 Translational Medicine associated with LIN-2102
100 Patents (Medical) associated with LIN-2102
100 Deals associated with LIN-2102