Hypertrophic CardiomyopathyPhase 1NCT06775834
Safety and Pharmacokinetics Study of HRS-1893 Tablets in Healthy Subjects and Those With Impaired Kidney Function
A Phase 1 study testing HRS-1893 in people with Hypertrophic Cardiomyopathy, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertrophic Cardiomyopathy
- What is being tested?
- HRS-1893
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 11 Feb 2025to 23 Jul 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Pharmacokinetic Study of HRS-1893 Tablets in Subjects With Mild and Moderate Renal Insufficiency and Healthy Subjects
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
- Being tested
- HRS-1893
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-1893Drug
HRS-1893 tablets.
| Study group | Role | What they receive |
|---|---|---|
| Normal Renal Function Group | Experimental | Not described Receives: Drug: HRS-1893 |
| Mild Renal Impairment Group | Experimental | Not described Receives: Drug: HRS-1893 |
| Moderate Renal Impairment Group | Experimental | Not described Receives: Drug: HRS-1893 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration (Cmax)
Measured: 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)
Measured: 0 hour to 16 days after the dosing.
Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-∞)
Measured: 0 hour to 16 days after the dosing.
Secondary outcomes (7)
Time to reach maximum plasma concentration (Tmax)
Measured: 0 hour to 16 days after the dosing.
Terminal half-life (t1/2)
Measured: 0 hour to 16 days after the dosing.
Apparent clearance (CL/F)
Measured: 0 hour to 16 days after the dosing.
Apparent volume of distribution (Vz/F)
Measured: 0 hour to 16 days after the dosing.
Cumulative excretion (Ae)
Measured: 0 hour to 16 days after the dosing.
Plasma protein binding rate (PPB)
Measured: 0 hour to 16 days after the dosing.
Incidence and severity of adverse events (AEs)
Measured: 0 hour to 16 days after the dosing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start11 Feb 2025
- Primary completion23 Jul 2025
- Study completion23 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Shandong Suncadia Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06775834
- Sponsor's protocol ID
- HRS-1893-103
- Status last verified
- Sep 2025
- First submitted
- 9 Jan 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Pharmacokinetic Study of HRS-1893 Tablets in Subjects With Mild and Moderate Renal Insufficiency and Healthy Subjects
- ClinicalTrials.gov ID
- NCT06775834
- Acronym / sponsor ID
- HRS-1893-103
- Conditions
- Hypertrophic Cardiomyopathy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Feb 2025 (actual)
- Primary completion
- 23 Jul 2025 (actual)
- Study completion
- 23 Jul 2025 (actual)
- First posted
- 15 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal Renal Function Group | Experimental | Drug: HRS-1893 |
| Mild Renal Impairment Group | Experimental | Drug: HRS-1893 |
| Moderate Renal Impairment Group | Experimental | Drug: HRS-1893 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRS-1893HRS-1893 tablets. | Drug | Mild Renal Impairment Group, Moderate Renal Impairment Group, Normal Renal Function Group |
Primary outcome
Maximum plasma concentration (Cmax)
Time frame: 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)
Time frame: 0 hour to 16 days after the dosing.
Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-∞)
Time frame: 0 hour to 16 days after the dosing.
7 secondary outcomes
Time to reach maximum plasma concentration (Tmax)
Time frame: 0 hour to 16 days after the dosing.
Terminal half-life (t1/2)
Time frame: 0 hour to 16 days after the dosing.
Apparent clearance (CL/F)
Time frame: 0 hour to 16 days after the dosing.
Apparent volume of distribution (Vz/F)
Time frame: 0 hour to 16 days after the dosing.
Cumulative excretion (Ae)
Time frame: 0 hour to 16 days after the dosing.
Plasma protein binding rate (PPB)
Time frame: 0 hour to 16 days after the dosing.
Incidence and severity of adverse events (AEs)
Time frame: 0 hour to 16 days after the dosing.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HRS-1893 in people with Hypertrophic Cardiomyopathy, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum plasma concentration (Cmax) (time frame: 0 hour to 16 days after the dosing.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.