[Translation] Single-center, double-blind, randomized, placebo-controlled, single-dose topical chloroquine phosphate gel to assess safety, tolerability and systemic exposure in Chinese healthy volunteers - Phase Ia study
主要目的是评估在中国健康志愿者中单次外用磷酸氯喹凝胶后的安全性和耐受性,并与安慰剂比较,为Ⅰb临床试验及后续临床试验提供依据; 次要目的是测定在中国健康志愿者中单次外用涂药磷酸氯喹凝胶后经皮吸收进入系统循环的药物暴露量,为Ⅰb临床试验及后续临床试验提供依据。
[Translation] The primary objective is to evaluate the safety and tolerability of a single topical administration of chloroquine phosphate gel in Chinese healthy volunteers, and to compare it with placebo to provide a basis for Ib clinical trials and follow-up clinical trials; the secondary objective is to determine in China The drug exposure in healthy volunteers after a single topical application of chloroquine phosphate gel percutaneously absorbed into the systemic circulation provides a basis for the Ib clinical trial and subsequent clinical trials.