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

March 4, 2025 updated by: Shandong Suncadia Medicine Co., Ltd.

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 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

84

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100032
        • Recruiting
        • Fuwai Hospital
        • Principal Investigator:
          • Lianming Kang
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HRS-1893 low-dose group
Drug: HRS-1893
HRS-1893 tablet.
Placebo Comparator: HRS-1893 placebo low-dose group
Drug: HRS-1893 placebo
HRS-1893 tablet placebo.
Experimental: HRS-1893 high-dose group
Drug: HRS-1893
HRS-1893 tablet.
Placebo Comparator: HRS-1893 placebo high-dose group
Drug: HRS-1893 placebo
HRS-1893 tablet placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse events (AEs)
Time Frame: Up to 14 weeks.
Up to 14 weeks.
The incidence of left ventricular ejection fraction (LVEF) < 50%
Time Frame: Up to 14 weeks.
Up to 14 weeks.

Secondary Outcome Measures

Outcome Measure
Time Frame
Peak oxygen uptake (pVO2) value
Time Frame: About 12 weeks.
About 12 weeks.
The cardiac troponin value
Time Frame: About 12 weeks.
About 12 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong Suncadia Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2025

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

February 4, 2025

First Submitted That Met QC Criteria

February 4, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 4, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRS-1893-202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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