[Translation] A Phase I clinical study to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic characteristics of single and multiple administrations of JMKX001149 tablets in healthy subjects, as well as the randomized, open, two-period crossover food effect.
主要目的:
评价JMKX001149片在健康受试者中单次、多次给药的安全性和耐受性。
次要目的:
评价JMKX001149片在健康受试者中单次、多次给药后的药代动力学(Pharmacokinetics, PK)特征;
评价食物对JMKX001149片药代动力学、药效学(Pharmacodynamics, PD)特征的影响;
评价JMKX001149片在健康受试者中单次、多次给药后的药效学特征;
评价JMKX001149片的代谢与排泄。
[Translation] Primary objective:
To evaluate the safety and tolerability of single and multiple administrations of JMKX001149 tablets in healthy subjects.
Secondary objectives:
To evaluate the pharmacokinetic (PK) characteristics of JMKX001149 tablets after single and multiple administrations in healthy subjects;
To evaluate the effect of food on the pharmacokinetic and pharmacodynamic (PD) characteristics of JMKX001149 tablets;
To evaluate the pharmacodynamic characteristics of JMKX001149 tablets after single and multiple administrations in healthy subjects;
To evaluate the metabolism and excretion of JMKX001149 tablets.