[Translation] Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of CRB4101 tablets in healthy adult subjects
评估健康成人单次服用CRB4101片后的安全性和耐受性。
次要目的:评估健康成人单次服用CRB4101片后的药代动力学(PK)和药效动力学(PD)特征。
探索性目的:1.探索性分析CRB4101(及其主要代谢产物,如必要)的血药浓度与QTc间期的关系;2.探索性分析CRB4101单次给药后的代谢与排泄特征(如必要);3.探索性分析CRB4101主要代谢产物的药代动力学特征(如必要);4.药物基因组学对药代动力学特征的影响(如必要)。
[Translation] To evaluate the safety and tolerability of a single dose of CRB4101 tablets in healthy adults.
Secondary objective: To evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of a single dose of CRB4101 tablets in healthy adults.
Exploratory objectives: 1. To explore the relationship between the blood concentration of CRB4101 (and its main metabolites, if necessary) and the QTc interval; 2. To explore the metabolism and excretion characteristics of CRB4101 after a single dose (if necessary); 3. To explore the pharmacokinetic characteristics of the main metabolites of CRB4101 (if necessary); 4. The effect of pharmacogenomics on pharmacokinetic characteristics (if necessary).