[Translation] A Phase I clinical trial to evaluate the safety, tolerability, and pharmacokinetic characteristics of KR230109 in healthy subjects with single and multiple transdermal administrations in a single-center, randomized, double-blind, placebo-controlled, dose-escalation design
主要研究目的:评价KR230109在健康成年受试者中单次与多次局部皮肤给药后的安全性与耐受性,为确定后期试验所采用的给药剂量及面积提供安全性依据。
次要研究目的:评价KR230109在健康成年受试者中单次与多次局部皮肤给药的系统暴露水平和药代动力学(PK)特征。
[Translation] Main study objectives: To evaluate the safety and tolerability of KR230109 after single and multiple topical skin administration in healthy adult subjects, and to provide a safety basis for determining the dosage and area of administration used in later trials.
Secondary study objectives: To evaluate the systemic exposure level and pharmacokinetic (PK) characteristics of KR230109 after single and multiple topical skin administration in healthy adult subjects.