CompletedPhase 1

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

China24 participantsStarted 2025-02-11

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. 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;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Maximum plasma concentration (Cmax)

Timeframe: 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)

Timeframe: 0 hour to 16 days after the dosing.

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

Timeframe: 0 hour to 16 days after the dosing.

Trial details

NCT IDNCT06775834

SponsorShandong Suncadia Medicine Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-07-23

View on ClinicalTrials.gov More Hypertrophic Cardiomyopathy trials

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. 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;

What they're measuring

Maximum plasma concentration (Cmax)

Timeframe: 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)

Timeframe: 0 hour to 16 days after the dosing.

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

Timeframe: 0 hour to 16 days after the dosing.