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

NCT ID: NCT06775834

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-11
• Study Completion Date: 2025-07-23

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Normal Renal Function Group

Group Type: EXPERIMENTAL

HRS-1893

Intervention Type: DRUG

HRS-1893 tablets.

Mild Renal Impairment Group

Group Type: EXPERIMENTAL

HRS-1893

Intervention Type: DRUG

HRS-1893 tablets.

Moderate Renal Impairment Group

Group Type: EXPERIMENTAL

HRS-1893

Intervention Type: DRUG

HRS-1893 tablets.

Interventions

HRS-1893

HRS-1893 tablets.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Sign the informed consent before the trial, and fully understand the content, process and possible adverse reactions of the trial;

2. Male or female subjects aged 18 to 65 (including 18 and 65);

3. Body mass index (BMI) ranges from 19 kg/m2 to 28 kg/m2 (including 18 and 28);

4. 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.

Exclusion Criteria

1. Suspected allergy to the study drug or any component of the study drug;

2. 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;

3. People with conditions associated with reduced neuromuscular transmission (myasthenia gravis, Lambert-Eaton syndrome, Duchenne muscular dystrophy);

4. Patients with a history of gastric or intestinal surgery that may affect drug absorption;

5. Participants with renal insufficiency who were judged by the investigator to be ineligible for the study;

6. Patients with large fluctuations or rapid deterioration of renal function within 2 weeks before administration, as judged by the investigator;

7. Subjects receiving renal replacement therapy within 3 months of the screening period or during the expected trial period;

8. Within 3 months before screening, patients with underlying diseases that induced chronic kidney disease and were poorly controlled according to the investigator's evaluation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shandong Suncadia Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Countries

China

Other Identifiers

HRS-1893-103

Identifier Type: -

Identifier Source: org_study_id