[Translation] A single-center, randomized, double-blind, placebo-controlled, single-dose and multiple-dose escalation phase I clinical study evaluating IMBZ18g in healthy Chinese subjects
主要目的:
? 评价中国健康受试者接受单次和多次IMBZ18g给药后的安全性和耐受性。
次要目的:
? 评估中国健康受试者接受单次和多次IMBZ18g给药后的药代动力学(Pharmacokinetics,PK)特征;
? 确定II期推荐给药剂量(Recommended Phase II Dose,RP2D);
评价中国健康受试者接受单次IMBZ18g给药后对QT间期的影响。
[Translation] Primary objective:
? To evaluate the safety and tolerability of single and multiple doses of IMBZ18g in healthy Chinese subjects.
Secondary objectives:
? To evaluate the pharmacokinetic (PK) characteristics of single and multiple doses of IMBZ18g in healthy Chinese subjects;
? To determine the recommended Phase II dose (RP2D);
To evaluate the effect of a single dose of IMBZ18g on the QT interval in healthy Chinese subjects.