[Translation] A single-center, randomized, double-blind, placebo-controlled, dose-escalation phase I clinical trial to evaluate the tolerability, safety, and preliminary efficacy of GP51801 injection in the treatment of medium-thickness donor site wounds
1、主要目的:评估GP51801注射液治疗中厚供皮区创面的耐受性和安全性,为后续临床试验提供给药依据。
2、次要目的:评估GP51801注射液治疗中厚供皮区创面的初步有效性及量效关系。
3、探索性研究目的:评价在取皮手术受试者注射GP51801后的GP51801残留量变化以及血浆SDF-1水平变化;评价GP51801注射液在取皮手术受试者中的免疫原性。
[Translation] 1. Primary purpose: To evaluate the tolerability and safety of GP51801 injection in the treatment of medium-thickness donor site wounds, and to provide a basis for dosing in subsequent clinical trials.
2. Secondary purpose: To evaluate the preliminary efficacy and dose-effect relationship of GP51801 injection in the treatment of medium-thickness donor site wounds.
3. Exploratory study purpose: To evaluate the changes in the residual amount of GP51801 and the changes in plasma SDF-1 levels after GP51801 injection in subjects undergoing skin harvesting surgery; to evaluate the immunogenicity of GP51801 injection in subjects undergoing skin harvesting surgery.