[Translation] A randomized, double-blind, placebo-controlled, multiple-dose, dose-escalation phase Ib/IIa clinical trial evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of IMC-003 for injection in patients with pulmonary arterial hypertension (PAH) receiving background therapy.
主要目的:评估肺动脉高压患者多次皮下注射IMC-003的安全性、耐受性;
次要目的:初步评价IMC-003在肺动脉高压患者中的疗效。评价肺动脉高压患者单次和多次皮下注射IMC-003的药代动力学(Pharmacokinetics, PK)特征。评价IMC-003的免疫原性。评估PAH的相关生物标志物。分析基因突变情况。
[Translation] Primary objective: To evaluate the safety and tolerability of multiple subcutaneous injections of IMC-003 in patients with pulmonary arterial hypertension (PAH).
Secondary objectives: To preliminarily evaluate the efficacy of IMC-003 in patients with PAH. To evaluate the pharmacokinetic (PK) characteristics of single and multiple subcutaneous injections of IMC-003 in patients with PAH. To evaluate the immunogenicity of IMC-003. To assess relevant biomarkers of PAH. To analyze gene mutation status.