[Translation] A randomized, open-label, multicenter, active drug and standard treatment parallel controlled phase II clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics and efficacy of human basic fibroblast growth factor (hbFGF) gel in the treatment of deep second-degree burns
Part A阶段
主要目的: 评价hbFGF凝胶治疗深Ⅱ度烧伤的安全性; 评价hbFGF凝胶治疗深Ⅱ度烧伤的初步有效性。
次要目的: 评价深Ⅱ度烧伤患者经皮肤局部给予hbFGF凝胶后的药代动力学(PK)特征; 评价深Ⅱ度烧伤患者经皮肤局部给予hbFGF凝胶后的免疫原性。
Part B 阶段 主要目的: 评价hbFGF凝胶治疗深Ⅱ度烧伤的有效性,并为后续试验推荐合适剂量; 评价hbFGF凝胶治疗深Ⅱ度烧伤的安全性。
次要目的: 根据Part A的药代动力学结果,确定是否在Part B中评价hbFGF凝胶的药代动力学特征; 根据Part A的免疫原性结果,确定是否在Part B中评价hbFGF凝胶的免疫原性。
[Translation] Part A phase
Main purpose: To evaluate the safety of hbFGF gel in the treatment of deep second-degree burns; To evaluate the preliminary effectiveness of hbFGF gel in the treatment of deep second-degree burns.
Secondary purpose: To evaluate the pharmacokinetic (PK) characteristics of hbFGF gel after topical administration of hbFGF gel through the skin in patients with deep second-degree burns; To evaluate the immunogenicity of hbFGF gel after topical administration of hbFGF gel through the skin in patients with deep second-degree burns.
Part B phase Main purpose: To evaluate the effectiveness of hbFGF gel in the treatment of deep second-degree burns and recommend appropriate doses for subsequent trials; To evaluate the safety of hbFGF gel in the treatment of deep second-degree burns.
Secondary purpose: Based on the pharmacokinetic results of Part A, determine whether to evaluate the pharmacokinetic characteristics of hbFGF gel in Part B; Based on the immunogenicity results of Part A, determine whether to evaluate the immunogenicity of hbFGF gel in Part B.