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

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

Recruiting
18-85 years
All
Phase 2

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Overview

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 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.

Study details
    Non-obstructive Hypertrophic Cardiomyopathy

NCT06816251

Shandong Suncadia Medicine Co., Ltd.

4 April 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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