Non-obstructive Hypertrophic Cardiomyopathy
Conditions
Brief 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.
Interventions
DRUGHRS-1893
HRS-1893 tablet.
DRUGHRS-1893 placebo
HRS-1893 tablet placebo.
Sponsors
Shandong Suncadia Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18\~85 years old (including boundary value), male or female. 2. Body mass index \< 35 kg/m2. 3. Understand the study procedures and methods, voluntarily participate in this trial, and sign the informed consent form in writing. 4. 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. 5. 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 criteria
1. Known or suspected infiltration, hereditary, or storage disorder that can cause myocardial hypertrophy. 2. Paroxysmal atrial flutter or atrial fibrillation with clinical symptoms at screening. 3. History of syncope or sustained ventricular tachycardia within 6 months prior to screening. 4. Those who have participated in the clinical trial of any drug or medical device within 3 months before screening. 5. Other conditions that the investigator considers the subject to be unsuitable for participating in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events (AEs) | Up to 14 weeks. |
| The incidence of left ventricular ejection fraction (LVEF) < 50% | Up to 14 weeks. |
Secondary
| Measure | Time frame |
|---|---|
| Peak oxygen uptake (pVO2) value | About 12 weeks. |
| The cardiac troponin value | About 12 weeks. |
Countries
China
Outcome results
None listed