A Phase II Clinical Study of HRS-1893 in 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
1 other identifier
interventional
84
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2025
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2025
CompletedFirst Posted
Study publicly available on registry
February 10, 2025
CompletedStudy Start
First participant enrolled
February 25, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2025
CompletedMarch 5, 2025
March 1, 2025
5 months
February 4, 2025
March 4, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Adverse events (AEs)
Up to 14 weeks.
The incidence of left ventricular ejection fraction (LVEF) < 50%
Up to 14 weeks.
Secondary Outcomes (2)
Peak oxygen uptake (pVO2) value
About 12 weeks.
The cardiac troponin value
About 12 weeks.
Study Arms (4)
HRS-1893 low-dose group
EXPERIMENTALHRS-1893 placebo low-dose group
PLACEBO COMPARATORHRS-1893 high-dose group
EXPERIMENTALHRS-1893 placebo high-dose group
PLACEBO COMPARATORInterventions
HRS-1893 tablet placebo.
Eligibility Criteria
You may qualify if:
- Age 18\~85 years old (including boundary value), male or female.
- Body mass index \< 35 kg/m2.
- Understand the study procedures and methods, voluntarily participate in this trial, and sign the informed consent form in writing.
- 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.
- 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.
You may not qualify if:
- Known or suspected infiltration, hereditary, or storage disorder that can cause myocardial hypertrophy.
- Paroxysmal atrial flutter or atrial fibrillation with clinical symptoms at screening.
- History of syncope or sustained ventricular tachycardia within 6 months prior to screening.
- Those who have participated in the clinical trial of any drug or medical device within 3 months before screening.
- Other conditions that the investigator considers the subject to be unsuitable for participating in this trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fuwai Hospital
Beijing, Beijing Municipality, 100032, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2025
First Posted
February 10, 2025
Study Start
February 25, 2025
Primary Completion
August 1, 2025
Study Completion
August 1, 2025
Last Updated
March 5, 2025
Record last verified: 2025-03