Safety and Pharmacokinetics Study of HRS-1893 Tablets in Healthy Subjects and Those With Impaired Kidney Function

NCT06775834 | Completed Phase 1

• 1 other identifier: HRS-1893-103
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to evaluate pharmacokinetics of HRS-1893 tablets in subjects with impaired kidney function in comparison with healthy subjects, to develop dose recommendations for patients with renal impairment.

Conditions

Hypertrophic Cardiomyopathy

Outcome Measures

Primary Outcomes (3)

• Maximum plasma concentration (Cmax)

  0 hour to 16 days after the dosing.

• Area under the plasma concentration-time curve from time zero to the time of last quantifiable analyte concentration (AUC0-t)

  0 hour to 16 days after the dosing.

• Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-∞)

  0 hour to 16 days after the dosing.

Secondary Outcomes (7)

• Time to reach maximum plasma concentration (Tmax)

  0 hour to 16 days after the dosing.

• Terminal half-life (t1/2)

  0 hour to 16 days after the dosing.

• Apparent clearance (CL/F)

  0 hour to 16 days after the dosing.

• Apparent volume of distribution (Vz/F)

  0 hour to 16 days after the dosing.

• Cumulative excretion (Ae)

  0 hour to 16 days after the dosing.

Study Arms (3)

Normal Renal Function Group

EXPERIMENTAL

Drug: HRS-1893

Mild Renal Impairment Group

EXPERIMENTAL

Drug: HRS-1893

Moderate Renal Impairment Group

EXPERIMENTAL

Drug: HRS-1893

Interventions

HRS-1893 DRUG

HRS-1893 tablets.

Mild Renal Impairment Group; Moderate Renal Impairment Group; Normal Renal Function Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sign the informed consent before the trial, and fully understand the content, process and possible adverse reactions of the trial;
• Male or female subjects aged 18 to 65 (including 18 and 65);
• Body mass index (BMI) ranges from 19 kg/m2 to 28 kg/m2 (including 18 and 28);
• The glomerular filtration rate should meet the following criteria (GFR, mL/min): Subjects with mild renal impairment: 60-89 mL/min; Subjects with moderate renal impairment: 30-59 mL/min.

You may not qualify if:

• Suspected allergy to the study drug or any component of the study drug;
• Patients with cardiogenic shock, severe conduction block, sick sinus syndrome, heart failure, sustained tachyarrhythmia, torsades de pointes (Tdp) or ventricular tachycardia, history of clinically significant T wave changes, myocardial infarction, angina pectoris;
• People with conditions associated with reduced neuromuscular transmission (myasthenia gravis, Lambert-Eaton syndrome, Duchenne muscular dystrophy);
• Patients with a history of gastric or intestinal surgery that may affect drug absorption;
• Participants with renal insufficiency who were judged by the investigator to be ineligible for the study;
• Patients with large fluctuations or rapid deterioration of renal function within 2 weeks before administration, as judged by the investigator;
• Subjects receiving renal replacement therapy within 3 months of the screening period or during the expected trial period;
• Within 3 months before screening, patients with underlying diseases that induced chronic kidney disease and were poorly controlled according to the investigator's evaluation.

Sponsors & Collaborators

• Shandong Suncadia Medicine Co., Ltd.: lead

Study Sites (1)

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, China

Location

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 15, 2025
• Study Start: February 11, 2025
• Primary Completion: July 23, 2025
• Study Completion: July 23, 2025
• Last Updated: September 10, 2025

Record last verified: 2025-09

Locations

CN (1)