Jiangsu Chiatai Qingjiang Pharmaceutical Co., Ltd.

Primary objectives: 1. To evaluate the tolerability and safety of QJ-19-0002 tablets after single and multiple oral administration in healthy subjects, determine the maximum tolerated dose, and investigate the adverse reaction characteristics of the drug; 2. To evaluate the pharmacokinetic (PK) characteristics of QJ-19-0002 tablets after single and multiple oral administration in healthy subjects, investigate the linear characteristics and accumulation of multiple administrations; 3. To evaluate the cardiotoxicity of the drug by C-QTc analysis. Secondary objectives: To evaluate the pharmacodynamic (PD) characteristics of QJ-19-0002 tablets after single and multiple oral administration in healthy subjects.

Methods: Chinese healthy subjects were used as test subjects. A self-crossover design was used to determine the time course of plasma concentration of crisaborole in healthy subjects after administration of crisaborole ointment [Specification: 2% (30 g: 0.6 g)] developed by Jiangsu Zhengda Qingjiang Pharmaceutical Co., Ltd., and the corresponding pharmacokinetic parameters were estimated. Clisborole ointment [trade name: Staquis®, specification: 2%] licensed by Anacor Pharmaceuticals, Inc. and produced by Pharmacia and Upjohn Company LLC was used as the reference preparation to evaluate the bioequivalence between the preparations and observe the safety of crisaborole ointment in Chinese healthy subjects.

Primary objective: To evaluate the pharmacokinetic interaction between QJ-19-0002 and colchicine. Secondary objectives: 1. To evaluate the safety and tolerability of QJ-19-0002 combined with colchicine in healthy subjects. 2. To investigate the pharmacodynamic (PD) characteristics of QJ-19-0002 combined with colchicine in healthy subjects.