A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Effects of Food on the Pharmacokinetics of HRS-1893 Tablets After Single and Multiple Ascending Oral Doses in Healthy Volunteers and Patients With Obstructive Hypertrophic Cardiomyopathy

Shandong Suncadia Medicine Co., Ltd.1 site in 1 country76 target enrollmentJune 5, 2023

ConditionsObstructive Hypertrophic Cardiomyopathy

InterventionsHRS-1893 Placebo

DrugsHRS-1893 Placebo

Overview

Phase: Phase 1
Intervention: HRS-1893
Conditions: Obstructive Hypertrophic Cardiomyopathy
Sponsor: Shandong Suncadia Medicine Co., Ltd.
Enrollment: 76
Locations: 1
Primary Endpoint: incidence of adverse event (AE), serious adverse event (SAE)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this phase Ⅰ study is to evaluate the safety, tolerability and pharmacokinetics of HRS-1893 in healthy volunteers and patients with obstructive hypertrophic cardiomyopathy

Registry

clinicaltrials.gov

Start Date

June 5, 2023

End Date

March 21, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shandong Suncadia Medicine Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Understand the study procedures and methods, voluntarily participate in the study, comply with study requirements, and sign the written informed consent form (ICF)
•Male or female aged 18-55（adult healthy volunteers）or 18-85 (oHCM patients).
•Body mass index (BMI) between 19 and 28 kg/m
•Normal Electrocardiogram (ECG)

Exclusion Criteria

•History of persistent tachyarrhythmia and syncope;
•A history of stomach or bowel surgery or excision (e.g. appendectomy, hernia repair, and/or cholecystectomy);
•Positive results of hepatitis B surface antigen, hepatitis C antibody, syphilis antibody and human immunodeficiency virus antibody.