[Translation] A randomized, double-blind, placebo-controlled Phase Ib/II clinical trial evaluating multiple dose escalation of JKN2306 tablets in patients undergoing laparoscopic surgery and dose escalation in patients undergoing laparoscopic/thoracoscopic surgery
Part 1腹腔镜手术后患者多次给药剂量递增(MAD)阶段:
主要目的:评价JKN2306片在腹腔镜手术后患者中多次给药的安全性、耐受性
次要目的:评价JKN2306片在腹腔镜手术后患者中多次给药的药代动力学(PK)特征
探索性目的:1)探索JKN2306片在腹腔镜手术后患者中多次给药的初步有效性;2) 探索JKN2306对转运体或代谢酶活性的影响。
Part2腹腔镜或胸腔镜手术后患者剂量探索阶段:
主要目的:评价JKN2306片在腹腔镜手术后患者中的有效性
次要目的:评价JKN2306片在腹腔镜或胸腔镜手术后患者中的安全性
探索性目的:1)探索JKN2306片在胸腔镜手术后患者中的初步有效性;2)在腹腔镜或胸腔镜手术后患者中,探索建立JKN2306群体药代动力学(popPK)模型
[Translation] Part 1 Multiple Ascending Dose (MAD) Phase for Patients Postoperatively Undergoing Laparoscopic Surgery:
Primary Objective: To evaluate the safety and tolerability of multiple-dose administration of JKN2306 tablets in patients undergoing laparoscopic surgery.
Secondary Objective: To evaluate the pharmacokinetic (PK) characteristics of multiple-dose administration of JKN2306 tablets in patients undergoing laparoscopic surgery.
Exploratory Objectives: 1) To investigate the preliminary efficacy of multiple-dose administration of JKN2306 tablets in patients undergoing laparoscopic surgery; 2) To investigate the effects of JKN2306 on the activities of transporters or metabolic enzymes. Part 2: Dose-finding Phase for Patients Following Laparoscopic or Thoracoscopic Surgery:
Primary Objective: To evaluate the efficacy of JKN2306 tablets in patients undergoing laparoscopic or thoracoscopic surgery.
Secondary Objective: To evaluate the safety of JKN2306 tablets in patients undergoing laparoscopic or thoracoscopic surgery.
Exploratory Objectives: 1) To investigate the preliminary efficacy of JKN2306 tablets in patients undergoing thoracoscopic or thoracoscopic surgery; 2) To explore the establishment of a population pharmacokinetic (popPK) model for JKN2306 in patients undergoing laparoscopic or thoracoscopic surgery.