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

NCT ID: NCT06816251

Last Updated: 2025-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-25

Study Completion Date

2025-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Non-obstructive Hypertrophic Cardiomyopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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HRS-1893 low-dose group

Group Type EXPERIMENTAL

HRS-1893

Intervention Type DRUG

HRS-1893 tablet.

HRS-1893 placebo low-dose group

Group Type PLACEBO_COMPARATOR

HRS-1893 placebo

Intervention Type DRUG

HRS-1893 tablet placebo.

HRS-1893 high-dose group

Group Type EXPERIMENTAL

HRS-1893

Intervention Type DRUG

HRS-1893 tablet.

HRS-1893 placebo high-dose group

Group Type PLACEBO_COMPARATOR

HRS-1893 placebo

Intervention Type DRUG

HRS-1893 tablet placebo.

Interventions

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HRS-1893

HRS-1893 tablet.

Intervention Type DRUG

HRS-1893 placebo

HRS-1893 tablet placebo.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shandong Suncadia Medicine Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fuwai Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jianhong Lv

Role: CONTACT

18921102884

Facility Contacts

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Lianming Kang

Role: primary

010-88396870

Other Identifiers

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HRS-1893-202

Identifier Type: -

Identifier Source: org_study_id

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