[Translation] A single-center, double-blind, randomized, placebo-controlled, single-dose topical chloroquine phosphate gel to evaluate the safety, tolerability and systemic exposure level of 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 application of chloroquine phosphate gel in healthy Chinese volunteers, and compare it with placebo, to provide a basis for clinical trials Ib and subsequent clinical trials; the secondary objective is to determine the amount of drug exposure that enters the systemic circulation through the skin after a single application of chloroquine phosphate gel in healthy Chinese volunteers, to provide a basis for clinical trials Ib and subsequent clinical trials.