Evaluating HRS-1893 for treating 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
This study is testing a new drug called HRS-1893 to see if it is safe and effective for people with non-obstructive hypertrophic cardiomyopathy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Shandong Suncadia Medicine Co., Ltd. Industry-sponsored |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06816251 on ClinicalTrials.gov |
What this trial studies
This clinical trial assesses the safety and tolerability of HRS-1893 in patients with non-obstructive hypertrophic cardiomyopathy. It also evaluates the efficacy and plasma concentrations of various dosing regimens of the drug. Participants will receive either HRS-1893 or a placebo, and their responses will be monitored throughout the study. The trial aims to gather data that could inform future treatment options for this condition.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 85 with a diagnosis of non-obstructive hypertrophic cardiomyopathy.
Not a fit: Patients with known or suspected conditions that cause myocardial hypertrophy or those with certain heart rhythm disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from non-obstructive hypertrophic cardiomyopathy.
How similar studies have performed: While this approach is being evaluated in this specific context, similar studies have shown promise in exploring new treatments for hypertrophic cardiomyopathy.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Beijing, Beijing Municipality
- Fuwai Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Jianhong Lv
- Email: jianhong.lv.jl9@hengrui.com
- Phone: 18921102884
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.