[Translation] A randomized, double-blind, clinical trial evaluating the safety, tolerability, pharmacokinetics and preliminary efficacy of QY211 gel in Chinese healthy subjects and patients with mild to moderate atopic dermatitis. Placebo-controlled phase I clinical study
本研究是一项评价QY211凝胶在中国健康受试者和轻中度特应性皮炎患者中单多次外用给药的安全性、耐受性、药代动力学特征和初步疗效的随机、双盲、安慰剂对照的Ⅰ期临床研究。主要目的为评估QY211凝胶在中国健康受试者和轻中度特应性皮炎患者中的安全性,耐受性。该研究分为Part1和Part2两部分进行:Part1为在中国健康成年受试者中进行的单中心、随机、双盲、安慰剂对照的单次和多次给药、剂量递增研究。分为三个组。Part2为在中国轻中度特应性皮炎患者中进行的多中心、随机、双盲、安慰剂对照的多次给药、剂量递增研究。分为四个组。
[Translation] This study is a randomized, randomized, multi-administration study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of QY211 gel in Chinese healthy subjects and patients with mild to moderate atopic dermatitis. Double-blind, placebo-controlled phase I clinical study. The main purpose is to evaluate the safety and tolerability of QY211 gel in Chinese healthy subjects and patients with mild to moderate atopic dermatitis. The study is divided into two parts, Part1 and Part2: Part1 is a single-center, randomized, double-blind, placebo-controlled single- and multiple-dose, dose-escalation study conducted in Chinese healthy adult subjects. into three groups. Part2 is a multi-center, randomized, double-blind, placebo-controlled multiple-dose, dose-escalation study in Chinese patients with mild to moderate atopic dermatitis. into four groups.