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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Fuwai Hospital
RECRUITING
Beijing
Contact Information
Primary
Jianhong Lv
jianhong.lv.jl9@hengrui.com
18921102884
Time Frame
Start Date: 2025-02-25
Estimated Completion Date: 2025-08
Participants
Target number of participants: 84
Treatments
Experimental: HRS-1893 low-dose group
Placebo_comparator: HRS-1893 placebo low-dose group
Experimental: HRS-1893 high-dose group
Placebo_comparator: HRS-1893 placebo high-dose group
Sponsors
Leads: Shandong Suncadia Medicine Co., Ltd.

This content was sourced from clinicaltrials.gov