[Translation] A randomized, double-blind, placebo-controlled, dose-escalation phase I clinical trial to evaluate the safety, tolerability, immunogenicity, pharmacokinetics, and preliminary efficacy of single and multiple doses of RGL-2102 for injection in patients with severe lower limb ischemia
主要研究目的:评价在严重下肢缺血患者中单次肌肉注射RGL-2102的安全性和耐受性。
次要研究目的:评价在严重下肢缺血患者中单次肌肉注射RGL-2102的药代动力学(PK)特征及免疫原性。
探索性研究目的:探索在严重下肢缺血患者中单次肌肉注射RGL-2102的初步有效性。
[Translation] Primary study objective: To evaluate the safety and tolerability of a single intramuscular injection of RGL-2102 in patients with severe lower limb ischemia.
Secondary study objective: To evaluate the pharmacokinetic (PK) characteristics and immunogenicity of a single intramuscular injection of RGL-2102 in patients with severe lower limb ischemia.
Exploratory study objective: To explore the preliminary efficacy of a single intramuscular injection of RGL-2102 in patients with severe lower limb ischemia.