[Translation] A randomized, double-blind, placebo-controlled, dose-escalation phase I clinical trial to evaluate the safety, tolerability, immunogenicity, pharmacokinetic characteristics and preliminary efficacy of topical single and multiple administrations of RGL-2102 in subjects with chronic wounds
第一部分:RGL-2102在慢性创面患者中局部单次给药剂量递增(SAD)
主要研究目的:评价外用RGL-2102在慢性创面患者中局部单次给药的安全性和耐受性;
次要研究目的:
评价外用RGL-2102在慢性创面患者中局部单次给药的药代动力学(PK)特征;
评价外用RGL-2102在慢性创面患者中局部单次给药的免疫原性。
第二部分:RGL-2102在慢性创面患者中局部多次给药剂量递增(MAD)
主要研究目的:评价外用RGL-2102在慢性创面患者中局部多次给药的安全性和耐受性;
次要研究目的:
评价外用RGL-2102在慢性创面患者中局部多次给药的药代动力学(PK)特征;
评价外用RGL-2102在慢性创面患者中局部多次给药的免疫原性;
评价外用RGL-2102在慢性创面患者中局部多次给药的初步有效性。
[Translation] Part I: Topical single-dose escalation (SAD) of RGL-2102 in patients with chronic wounds
Main study objectives: To evaluate the safety and tolerability of topical single-dose administration of topical RGL-2102 in patients with chronic wounds;
Secondary study objectives:
To evaluate the pharmacokinetic (PK) characteristics of topical single-dose administration of topical RGL-2102 in patients with chronic wounds;
To evaluate the immunogenicity of topical single-dose administration of topical RGL-2102 in patients with chronic wounds.
Part II: Multiple escalating doses (MAD) of topical RGL-2102 in patients with chronic wounds
Main study objectives: To evaluate the safety and tolerability of multiple topical administration of topical RGL-2102 in patients with chronic wounds;
Secondary study objectives:
To evaluate the pharmacokinetic (PK) characteristics of multiple topical administration of topical RGL-2102 in patients with chronic wounds;
To evaluate the immunogenicity of multiple topical administration of topical RGL-2102 in patients with chronic wounds;
To evaluate the preliminary efficacy of multiple topical administration of topical RGL-2102 in patients with chronic wounds.