A Phase II Clinical Study of HRS-1893 in Non-obstructive Hypertrophic Cardiomyopathy
A Multicenter, Randomized, Double-blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of HRS-1893 in Non-Obstructive Hypertrophic Cardiomyopathy
Shandong Suncadia Medicine Co., Ltd.
84 participants
Feb 25, 2025
INTERVENTIONAL
Conditions
Summary
This study mainly evaluated the safety and tolerability of HRS-1893 in subjects with non-obstructive hypertrophic cardiomyopathy, and the efficacy and plasma concentrations of different dosing regimens in subjects with non-obstructive hypertrophic cardiomyopathy.
Eligibility
Inclusion Criteria5
- Age 18\~85 years old (including boundary value), male or female.
- Body mass index \< 35 kg/m2.
- Understand the study procedures and methods, voluntarily participate in this trial, and sign the informed consent form in writing.
- Female subjects of childbearing potential must have a serum pregnancy test prior to the first dose with a negative result and must be non-lactating during the study.
- Female subjects of childbearing potential and male subjects whose partners are women of childbearing potential must agree to refrain from donating sperm/eggs from the time of signing the informed consent form until 3 months after the last dose of the trial drug, and comply with the relevant contraceptive requirements.
Exclusion Criteria5
- Known or suspected infiltration, hereditary, or storage disorder that can cause myocardial hypertrophy.
- Paroxysmal atrial flutter or atrial fibrillation with clinical symptoms at screening.
- History of syncope or sustained ventricular tachycardia within 6 months prior to screening.
- Those who have participated in the clinical trial of any drug or medical device within 3 months before screening.
- Other conditions that the investigator considers the subject to be unsuitable for participating in this trial.
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Interventions
HRS-1893 tablet.
HRS-1893 tablet placebo.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06816251