[Translation] A randomized, double-blind, placebo-controlled Phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of single or multiple topical administrations of QY211 gel in Chinese healthy subjects and patients with mild to moderate atopic dermatitis
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, double-blind, placebo-controlled Phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of single and multiple topical administration of QY211 gel in healthy Chinese subjects and patients with mild to moderate atopic dermatitis. The main purpose is to evaluate the safety and tolerability of QY211 gel in healthy Chinese subjects and patients with mild to moderate atopic dermatitis. The study is divided into Part 1 and Part 2: Part 1 is a single-center, randomized, double-blind, placebo-controlled single and multiple administration, dose escalation study conducted in healthy adult subjects in China. It is divided into three groups. Part 2 is a multicenter, randomized, double-blind, placebo-controlled multiple administration, dose escalation study conducted in patients with mild to moderate atopic dermatitis in China. It is divided into four groups.