[Translation] A Phase I clinical study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of IBNI617 enteric-coated capsules in healthy participants using single-dose, multiple-dose escalation methods.
(1)主要研究目的: 评价健康参与者单次及多次服用IBNI617肠溶胶囊后的安全性、耐受性;
(2)次要研究目的: 评价健康参与者单次及多次服用IBNI617肠溶胶囊后的药代动力学特征; 评价健康参与者多次服用IBNI617肠溶胶囊后的药效学特征
[Translation] (1) Primary objective: To evaluate the safety and tolerability of single and multiple doses of IBNI617 enteric-coated capsules in healthy participants;
(2) Secondary objectives: To evaluate the pharmacokinetic characteristics of single and multiple doses of IBNI617 enteric-coated capsules in healthy participants; To evaluate the pharmacodynamic characteristics of multiple doses of IBNI617 enteric-coated capsules in healthy participants.