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

Shandong Suncadia Medicine

Status and phase: Enrolling; Phase 2

Conditions: Non-obstructive Hypertrophic Cardiomyopathy

Treatments: Drug: HRS-1893 placebo; Drug: HRS-1893

Study type: Interventional

Funder types: Industry

Identifiers

NCT06816251

HRS-1893-202

Details and patient eligibility

About

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.

Enrollment: 84 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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84 participants in 4 patient groups, including a placebo group

HRS-1893 low-dose group

Experimental group

Treatment:

Drug: HRS-1893

HRS-1893 placebo low-dose group

Placebo Comparator group

Treatment:

Drug: HRS-1893 placebo

HRS-1893 high-dose group

Experimental group

Treatment:

Drug: HRS-1893

HRS-1893 placebo high-dose group

Placebo Comparator group

Treatment:

Drug: HRS-1893 placebo