[Translation] A randomized, double-blind, placebo-controlled phase I clinical study evaluating the safety, tolerability, and immunogenicity of WSK-V108E in patients with mild to moderate facial acne vulgaris.
本研究的试验目的是:首次在患有轻中度面部“青春痘”(寻常痤疮)的患者中,评估新药WSK-V108E的安全性、耐受性和免疫原性。通过随机分组、双盲设计并使用安慰剂进行对照的科学方法,重点观察受试者用药后是否会出现不良反应、身体能否良好耐受,以及是否会因此产生抗体等免疫变化。简言之,这是一项为后续疗效研究奠定重要安全基础的早期临床研究。
[Translation] The objective of this study was to evaluate the safety, tolerability, and immunogenicity of the novel drug WSK-V108E in patients with mild to moderate facial acne (acne vulgaris) for the first time. Using a randomized, double-blind design with a placebo control, the study focused on observing whether adverse reactions occurred in subjects, whether the drug was well tolerated, and whether immune changes such as antibody production occurred. In short, this is an early-stage clinical study that lays an important safety foundation for subsequent efficacy research.