[Translation] Clinical trials of the tolerability, safety, pharmacokinetics, and efficacy of HLK-5003 film-forming agent in patients with mild to moderate onychomycosis.
主要目的:评价HLK-5003涂膜剂在轻、中度甲真菌病患者中的安全性和耐受性
次要目的:1) 评价HLK-5003涂膜剂在轻、中度甲真菌病患者中的药代动力学特征;2) 初步评价HLK-5003涂膜剂在轻、中度甲真菌病患者中的有效性,探索HLK-5003在轻、中度甲真菌病患者中的最佳剂量,为后期临床试验提供依据。
[Translation] Primary Objective: To evaluate the safety and tolerability of HLK-5003 film-coated onychomycosis in patients with mild to moderate onychomycosis.
Secondary Objectives: 1) To evaluate the pharmacokinetic characteristics of HLK-5003 film-coated onychomycosis in patients with mild to moderate onychomycosis; 2) To preliminarily evaluate the efficacy of HLK-5003 film-coated onychomycosis in patients with mild to moderate onychomycosis, and to explore the optimal dose of HLK-5003 in these patients, providing a basis for subsequent clinical trials.