CardiomyopathyPhase 1NCT07272330
A Phase I Trial on the Relative Bioavailability and Food Effect of HRS-1893 Tablets in Healthy Subjects
A Phase 1 study testing HRS-1893 tablet A and HRS-1893 tablet B in people with Cardiomyopathy, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.
Trial summary
This Phase I clinical trial will investigate the relative bioavailability between two formulations of HRS-1893 tablets and the influence of food on the drug's pharmacokinetics in healthy adult participants. The safety and tolerability of HRS-1893 will also be monitored. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiomyopathy
- What is being tested?
- HRS-1893 tablet A and HRS-1893 tablet B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteChina
- Study dates
- 11 Dec 2025to 21 Mar 2026
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects aged 18 to 55 years (inclusive), regardless of gender.
- Body mass index (BMI) between 19 and 28 kg/m² (inclusive), with body weight ≥50.0 kg and <90.0 kg for men, and ≥45.0 kg and <90.0 kg for women.
- No abnormalities of clinical significance are found upon comprehensive physical examination and laboratory tests, or only minor abnormalities that are deemed by the investigator not to affect the subject's eligibility for enrollment.
- No clinically significant abnormalities on the 12-lead ECG.
- The subject must understand the study procedures and methods, voluntarily agree to participate, and provide written informed consent.
Who cannot join
- Subjects with suspected hypersensitivity to the investigational drug or any excipient.
- The subject has a history of syncope.
- Exclusion due to blood pressure: Systolic Blood Pressure (SBP) >140 mmHg or <90 mmHg; OR Diastolic Blood Pressure (DBP) >90 mmHg or <60 mmHg, as determined by the investigator to be clinically significant.
- History of gastric or intestinal surgery that, in the investigator's judgment, may affect drug absorption.
- A positive result in any one of the following infectious disease screening tests during the screening period: hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), treponema pallidum antibody (syphilis), or human immunodeficiency virus antibody/antigen (HIV-Ab/Ag).
- Subjects who meet any of the following criteria will be excluded: (1) Smoking: Average daily cigarette consumption of more than 5 cigarettes within the 4 weeks prior to screening. (2) Alcohol: Average daily alcohol intake exceeding 15 g within one week prior to screening (15 g of alcohol is equivalent to 450 mL of beer, 150 mL of wine, or 50 mL of low-alcohol spirits). (3) Non-compliance: Inability or unwillingness to abstain from smoking, alcohol, and caffeine-containing foods or beverages during the screening period and the entire study duration. (4) Diet: Have special dietary requirements, cannot comply with the standardized diet provided in the study, or have a history of substance abuse.
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- History of substance abuse.
- Use of any prescription drugs, over-the-counter medications, or Chinese herbal medicines within 1 month prior to dosing, or the use of any drug within 5 half-lives prior to screening (whichever is longer). Additionally, subjects who plan to take any non-study medications during the trial period will be excluded.
- Any other circumstances that, in the investigator's judgment, make the subject unsuitable for participation in the trial. This includes physiological or psychological conditions that may increase the trial risk, affect the subject's protocol compliance, or impact the subject's ability to complete the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 100029
About this study
Official title: A Phase I Study to Evaluate the Relative Bioavailability of Different HRS-1893 Formulations and the Effect of Food on the Pharmacokinetics of HRS-1893 Tablets in Healthy Subjects
This Phase I clinical trial will investigate the relative bioavailability between two formulations of HRS-1893 tablets and the influence of food on the drug's pharmacokinetics in healthy adult participants. The safety and tolerability of HRS-1893 will also be monitored.
- Conditions
- Cardiomyopathy
- Being tested
- HRS-1893 tablet A, HRS-1893 tablet B
- Medical subject headings
- Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-1893 tablet ADrug
Specified dose on specified days.
HRS-1893 tablet BDrug
Specified dose on specified days.
| Study group | Role | What they receive |
|---|---|---|
| HRS-1893 tablet A and HRS-1893 tablet B Group | Experimental | Not described Receives: Drug: HRS-1893 tablet A; Drug: HRS-1893 tablet B |
| HRS-1893 tablet B Group | Experimental | Not described Receives: Drug: HRS-1893 tablet B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak concentration (Cmax)
Measured: From Day 1 to Day 25 in part 1, from Day 1 to Day 17 in part 2.
Area under the plasma concentration-time curve from time zero to the last quantifiable time point (AUC0-t)
Measured: From Day 1 to Day 25 in part 1, from Day 1 to Day 17 in part 2.
Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-∞)
Measured: From Day 1 to Day 25 in part 1, from Day 1 to Day 17 in part 2.
Secondary outcomes (5)
Time to reach peak concentration (Tmax)
Measured: From Day 1 to Day 25 in part 1, from Day 1 to Day 17 in part 2.
Elimination half-life (t1/2)
Measured: From Day 1 to Day 25 in part 1, from Day 1 to Day 17 in part 2.
Apparent clearance (CL/F)
Measured: From Day 1 to Day 25 in part 1, from Day 1 to Day 17 in part 2.
Apparent volume of distribution (Vz/F)
Measured: From Day 1 to Day 25 in part 1, from Day 1 to Day 17 in part 2.
The incidence and severity of any adverse events (AEs)
Measured: From Day 1 to Day 29 in part 1, from Day 1 to Day 21 in part 2.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start11 Dec 2025
- Primary completion21 Mar 2026
- Study completion21 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 38 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
- NCT07272330
- Sponsor's protocol ID
- HRS-1893-106
- Status last verified
- Apr 2026
- First submitted
- 26 Nov 2025
- Last updated
- 2 Apr 2026
- 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 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Relative Bioavailability of Different HRS-1893 Formulations and the Effect of Food on the Pharmacokinetics of HRS-1893 Tablets in Healthy Subjects
- ClinicalTrials.gov ID
- NCT07272330
- Acronym / sponsor ID
- HRS-1893-106
- Conditions
- Cardiomyopathy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Dec 2025 (actual)
- Primary completion
- 21 Mar 2026 (actual)
- Study completion
- 21 Mar 2026 (actual)
- First posted
- 9 Dec 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.
This Phase I clinical trial will investigate the relative bioavailability between two formulations of HRS-1893 tablets and the influence of food on the drug's pharmacokinetics in healthy adult participants. The safety and tolerability of HRS-1893 will also be monitored.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HRS-1893 tablet A and HRS-1893 tablet B Group | Experimental | Drug: HRS-1893 tablet A, Drug: HRS-1893 tablet B |
| HRS-1893 tablet B Group | Experimental | Drug: HRS-1893 tablet B |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subjects aged 18 to 55 years (inclusive), regardless of gender.
- Body mass index (BMI) between 19 and 28 kg/m² (inclusive), with body weight ≥50.0 kg and <90.0 kg for men, and ≥45.0 kg and <90.0 kg for women.
- No abnormalities of clinical significance are found upon comprehensive physical examination and laboratory tests, or only minor abnormalities that are deemed by the investigator not to affect the subject's eligibility for enrollment.
- No clinically significant abnormalities on the 12-lead ECG.
- The subject must understand the study procedures and methods, voluntarily agree to participate, and provide written informed consent.
Key exclusion criteria (9 listed)
- Subjects with suspected hypersensitivity to the investigational drug or any excipient.
- The subject has a history of syncope.
- Exclusion due to blood pressure: Systolic Blood Pressure (SBP) >140 mmHg or <90 mmHg; OR Diastolic Blood Pressure (DBP) >90 mmHg or <60 mmHg, as determined by the investigator to be clinically significant.
- History of gastric or intestinal surgery that, in the investigator's judgment, may affect drug absorption.
- A positive result in any one of the following infectious disease screening tests during the screening period: hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), treponema pallidum antibody (syphilis), or human immunodeficiency virus antibody/antigen (HIV-Ab/Ag).
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-1893 tablet ASpecified dose on specified days. | Drug | HRS-1893 tablet A and HRS-1893 tablet B Group |
| HRS-1893 tablet BSpecified dose on specified days. | Drug | HRS-1893 tablet A and HRS-1893 tablet B Group, HRS-1893 tablet B Group |
Primary outcome
Peak concentration (Cmax)
Time frame: From Day 1 to Day 25 in part 1, from Day 1 to Day 17 in part 2.
Area under the plasma concentration-time curve from time zero to the last quantifiable time point (AUC0-t)
Time frame: From Day 1 to Day 25 in part 1, from Day 1 to Day 17 in part 2.
Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-∞)
Time frame: From Day 1 to Day 25 in part 1, from Day 1 to Day 17 in part 2.
5 secondary outcomes
Time to reach peak concentration (Tmax)
Time frame: From Day 1 to Day 25 in part 1, from Day 1 to Day 17 in part 2.
Elimination half-life (t1/2)
Time frame: From Day 1 to Day 25 in part 1, from Day 1 to Day 17 in part 2.
Apparent clearance (CL/F)
Time frame: From Day 1 to Day 25 in part 1, from Day 1 to Day 17 in part 2.
Apparent volume of distribution (Vz/F)
Time frame: From Day 1 to Day 25 in part 1, from Day 1 to Day 17 in part 2.
The incidence and severity of any adverse events (AEs)
Time frame: From Day 1 to Day 29 in part 1, from Day 1 to Day 21 in part 2.
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 2 Apr 2026.
- 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 tablet A and HRS-1893 tablet B in people with 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 5 inclusion and 9 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 2 Apr 2026. 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?
Peak concentration (Cmax) (time frame: From Day 1 to Day 25 in part 1, from Day 1 to Day 17 in part 2.). 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 2 Apr 2026.