[Translation] A Phase I, randomized, double-blind, placebo-controlled, single- and multiple-dose escalation study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of oral AL01211 in healthy volunteers
主要目的:
评估单剂量和多剂量给药AL01211在中国健康成年受试者中的安全性和耐受性。
次要目的:
评估AL01211在中国健康成年受试者中的药代动力学(pharmacokinetics, PK)特征;
评估AL01211在中国健康成年受试者中的药效动力学(pharmacodynamics, PD)特征,即葡萄糖神经酰胺(glucosylceramide, GL-1)水平变化。
[Translation] Primary objective:
To evaluate the safety and tolerability of single-dose and multiple-dose AL01211 in healthy Chinese adult subjects.
Secondary objectives:
To evaluate the pharmacokinetic (PK) characteristics of AL01211 in healthy Chinese adult subjects;
To evaluate the pharmacodynamic (PD) characteristics of AL01211 in healthy Chinese adult subjects, i.e., the changes in glucosylceramide (GL-1) levels.