[Translation] A randomized, double-blind, placebo-controlled, single-dose and multiple-ascending, first-in-human Phase I trial to evaluate the safety, tolerability, and pharmacokinetics of IPG11406 in healthy adult subjects
A 部分-单剂量递增(SAD)
? 主要目的:
1. 评价单剂量口服 IPG11406 的安全性和耐受性
? 次要目的:
1. 评价单剂量口服 IPG11406 的药代动力学(pharmacokinetics,PK)特征
2. 评价食物对单剂量口服 IPG11406 的药代动力学的影响
A 部分-单剂量递增(SAD)
? 探索性目的(暂定队列 4)
评价单剂量口服 IPG11406 的尿药代动力学(pharmacokinetics,PK)特
征
B 部分-多剂量递增(MAD)
? 主要目的:
1. 评价多剂量口服 IPG11406 的安全性和耐受性
? 次要目的:
1. 评价多剂量口服 IPG11406 的药代动力学(pharmacokinetics,PK)特征
[Translation] Part A - Single Ascending Dose (SAD)
? main purpose:
1. Evaluate the safety and tolerability of a single oral dose of IPG11406
? Secondary purpose:
1. Evaluate the pharmacokinetics (PK) characteristics of a single oral dose of IPG11406
2. Evaluate the effect of food on the pharmacokinetics of a single oral dose of IPG11406
Part A - Single Ascending Dose (SAD)
? Exploratory purposes (tentative cohort 4)
Evaluation of the urinary pharmacokinetics (PK) properties of a single oral dose of IPG11406
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Part B - Multiple Ascending Dose (MAD)
? main purpose:
1. Evaluate the safety and tolerability of multiple oral doses of IPG11406
? Secondary purpose:
1. Evaluate the pharmacokinetics (PK) characteristics of multiple oral doses of IPG11406