A Phase I, Randomized, Double-blind, Placebo- and Active-controlled, Four-period Crossover Study of HDM1002 Tablets on Cardiac Repolarization in Healthy Adults

What this Trial Is About

Researchers are studying the effects of a single oral dose of HDM1002 tablets on the hearts electrical activity, specifically the QTQTc interval, in healthy adults aged 18 to 45 years. This Phase I clinical trial aims to understand how HDM1002 influences cardiac repolarization compared to placebo and an active control drug, Moxifloxacin. The study is led by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. and is designed as a randomized, double-blind, placebo- and positive-controlled, four-period crossover trial. Participants receive one of several treatments during the study a single oral dose of HDM1002 at either 200 mg or 400 mg, a placebo tablet, or a single 400 mg dose of Moxifloxacin. The crossover design means that each participant will receive all treatments in different periods, allowing direct comparison within the same individual. Each treatment period includes monitoring up to 48 hours post-dose to assess the drugs effect on cardiac repolarization. During the trial, participants will undergo baseline and post-dose electrocardiograms ECGs to measure changes in QTc intervals. Researchers will also collect blood samples to analyze HDM1002 plasma concentrations and monitor heart rate, PR, and QRS intervals. Safety is closely observed through adverse event tracking for up to 25 days. The total study duration includes multiple treatment periods with washout intervals, ensuring comprehensive evaluation of HDM1002s cardiac effects in healthy volunteers.

A Study of HDM1002 Tablets on Cardiac Repolarization in Healthy Subjects