[Translation] A phase I, randomized, double-blind, placebo-controlled, single-dose and multiple-dose escalation trial evaluating the safety and pharmacokinetic characteristics of IGS01.
主要试验目的
SAD试验部分: 在健康成人试验参与者中,评价IGS01单次口服给药的安全性,并探索最大耐受剂量
MAD试验部分:
在健康成人试验参与者中,评价IGS01多次口服给药的安全性和耐受性
次要目的:
SAD试验部分:
在健康成人试验参与者中,评价单次口服给药下IGS01及其活性代谢产物的PK特征
在健康成人试验参与者中,通过药物浓度-QTc间期模型,探索IGS01对QTc间期的影响
MAD试验部分:
在健康成人试验参与者中,评价多次口服给药下IGS01及其活性代谢产物的PK特征
在健康成人试验参与者中,探索IGS01多次口服给药对锥体外系症状的影响
[Translation] Primary Objectives:
SAD Trial Part: To evaluate the safety of a single oral dose of IGS01 and to explore the maximum tolerated dose in healthy adult participants.
MAD Trial Part: To evaluate the safety and tolerability of multiple oral doses of IGS01 in healthy adult participants.
Secondary Objectives:
SAD Trial Part: To evaluate the pharmacokinetic (PK) characteristics of IGS01 and its active metabolites after a single oral dose in healthy adult participants.
To explore the effect of IGS01 on the QTc interval using a drug concentration-QTc interval model in healthy adult participants.
MAD Trial Part: To evaluate the PK characteristics of IGS01 and its active metabolites after multiple oral doses in healthy adult participants.
To explore the effect of multiple oral doses of IGS01 on extrapyramidal symptoms in healthy adult participants.