[Translation] A randomized, double-blind, placebo-controlled, single-dose and multiple-dose ascending phase I first-in-human trial to evaluate the safety, tolerability, and pharmacokinetics of IPG8294 in healthy adult subjects
A部分-单剂量递增(SAD)
主要目的:
评价单剂量口服IPG8294的安全性和耐受性
次要目的:
1.评价单剂量口服IPG8294的药代动力学(pharmacokinetics,PK)特征
2.评价食物对单剂量口服IPG8294的药代动力学的影响评价口服IPG8294对受试者生物标志物的影响
B部分-多剂量递增(MAD)
主要目的:
评价多剂量口服IPG8294的安全性和耐受性
次要目的:
1.评价多剂量口服IPG8294的药代动力学(pharmacokinetics,PK)特征
2.评价口服IPG8294对受试者生物标志物的影响
[Translation] Part A - Single Ascending Dose (SAD)
Primary Objective:
To evaluate the safety and tolerability of a single oral dose of IPG8294
Secondary Objectives:
1. To evaluate the pharmacokinetic (PK) characteristics of a single oral dose of IPG8294
2. To evaluate the effect of food on the pharmacokinetics of a single oral dose of IPG8294
Evaluate the effect of oral IPG8294 on biomarkers of subjects
Part B - Multiple Ascending Dose (MAD)
Primary Objective:
To evaluate the safety and tolerability of multiple oral doses of IPG8294
Secondary Objectives:
1. To evaluate the pharmacokinetic (PK) characteristics of multiple oral doses of IPG8294
2. To evaluate the effect of oral IPG8294 on biomarkers of subjects