Phase II Study to Test the Safety and Effectiveness of HRS-1893 Tablets for Adults with Non-Obstructive Hypertrophic Cardiomyopathy

What this Trial Is About

Researchers are evaluating the safety, tolerability, and effectiveness of a drug called HRS-1893 in adults with non-obstructive hypertrophic cardiomyopathy, a heart condition. This Phase II randomized, double-blind, placebo-controlled study aims to better understand how different doses of HRS-1893 affect the heart and plasma drug levels in this patient group. The study is sponsored by Shandong Suncadia Medicine Co., Ltd. Participants will be randomly assigned to one of four groups low-dose HRS-1893, low-dose placebo, high-dose HRS-1893, or high-dose placebo. The study includes up to 14 weeks of monitoring to assess safety and heart function, with key focus on left ventricular ejection fraction and adverse events. Different dosing regimens will be tested to evaluate the drugs impact. During the study, participants will undergo regular assessments including heart function tests and blood tests to measure markers such as cardiac troponin and peak oxygen uptake. Researchers will closely monitor adverse effects and heart performance over about 12 to 14 weeks. The total duration of participation includes screening, treatment, and follow-up to ensure thorough evaluation of HRS-1893s effects and safety profile.

A Phase II Clinical Study of HRS-1893 in Non-obstructive Hypertrophic Cardiomyopathy