HyperlipidemiasPhase 1NCT07322016
A Study of HRS-1301 Tablets in Healthy Subjects and Those With Impaired Kidney Function
A Phase 1 study testing HRS-1301 Tablet in people with Hyperlipidemias, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.
Trial summary
The primary objective of this study is to evaluate pharmacokinetics of HRS-1301 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
- Hyperlipidemias
- What is being tested?
- HRS-1301 Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 13 Jan 2026to 4 Aug 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 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 18 kg/m2 to 30 kg/m2 (including 18 and 30),and Male weight ≥ 50.0 kg, female weight ≥ 45.0 kg;
- 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; Subjects with severe renal function impairment: 15~29 mL/min.
Who cannot join
- Individuals with a specific history of allergies (such as asthma, urticaria, eczema, etc.), or those with an allergic constitution (such as those allergic to any drug or food), or those known to be allergic to any component of the studied drug;
- Those with cardiogenic shock, severe conduction obstruction, sick sinus syndrome, heart failure (NYHA grade III-IV), persistent rapid arrhythmia, tortuous ventricular tachycardia or ventricular tachycardia at the pointed point, a history of clinically significant T-wave changes, myocardial infarction, or angina pectoris;
- Suffering from malignant tumors, or having a history of malignant tumors within 5 years prior to screening (excluding skin non-melanomas that have been treated without recurrence signs and resected cervical intraepithelial neoplasia);
- Those with a history of gastric or intestinal surgery that some researchers believe may affect drug absorption;
- Those who have suffered severe trauma or undergone major surgical operations within the three months prior to screening, or who plan to undergo surgery during the trial period;
- Those who have participated in any clinical trials of drugs or medical devices within three months prior to screening, or those who are still within five half-lives of the drug before screening (whichever is longer);
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- Those who have donated blood of ≥ 400 mL within 4 weeks before screening, or have suffered severe blood loss (blood loss ≥ 400 mL), or have received blood transfusion within 8 weeks;
- Those who received live (attenuated) vaccines within 4 weeks prior to screening or those who plan to receive them during the trial;
- Those with potential difficulties in blood collection and a history of fainting at the sight of needles or blood;
- For patients with renal insufficiency,those who have received renal replacement therapy (such as peritoneal dialysis, hemodialysis, etc.) within 3 months prior to the screening or during the expected trial period;
- For patients with renal insufficiency，screening individuals with underlying diseases that induce chronic kidney disease within the previous three months and are judged by researchers to be poorly controlled, such as diabetic patients with HbA1c > 10%, and hypertensive patients with systolic blood pressure > 180 mmHg and diastolic blood pressure > 120 mmHg, etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-dose, Open-label Phase I Clinical Trial Comparing the Pharmacokinetics, Safety and Pharmacodynamics of HRS-1301 Tablets in Subjects With Mild, Moderate and Severe Renal Insufficiency and Healthy Subjects
The primary objective of this study is to evaluate pharmacokinetics of HRS-1301 tablets in subjects with impaired kidney function in comparison with healthy subjects, to develop dose recommendations for patients with renal impairment.
- Conditions
- Hyperlipidemias
- Being tested
- HRS-1301 Tablet
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-1301 TabletDrug
HRS-1301 tablet, oral medication.
| Study group | Role | What they receive |
|---|---|---|
| HRS-1301 Tablet Group | Experimental | Treatment for oral medication. Receives: Drug: HRS-1301 Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum concentration (Cmax).
Pharmacokinetic parameters of HRS-1301 in plasma.
Measured: 0 hour to 8 days after dosing.
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last).
Pharmacokinetic parameters of HRS-1301 in plasma.
Measured: 0 hour to 8 days after dosing.
Area under the concentration-time curve from time zero to infinity (AUC0-inf).
Pharmacokinetic parameters of HRS-1301 in plasma.
Measured: 0 hour to 8 days after dosing.
Secondary outcomes (9)
Time of maximum concentration (Tmax).
Pharmacokinetic parameters of HRS-1301 in plasma.
Measured: 0 hour to 8 days after dosing.
Area under the concentration-time curve from time zero to the end of the dosing interval tau (AUC0-tau).
Pharmacokinetic parameters of HRS-1301 in plasma.
Measured: 0 hour to 8 days after dosing.
Elimination half-life (t1/2).
Pharmacokinetic parameters of HRS-1301 in plasma.
Measured: 0 hour to 8 days after dosing.
Apparent clearance (CL/F).
Pharmacokinetic parameters of HRS-1301 in plasma.
Measured: 0 hour to 8 days after dosing.
Apparent volume of distribution (Vz/F).
Pharmacokinetic parameters of HRS-1301 in plasma.
Measured: 0 hour to 8 days after dosing.
Cumulative drug excretion in urine (Ae,urine).
Pharmacokinetic parameters of HRS-1301 in urine.
Measured: 0 hour to 6 days after dosing.
Cumulative drug excretion fraction in urine (fe,urine).
Pharmacokinetic parameters of HRS-1301 in urine.
Measured: 0 hour to 6 days after dosing.
Incidence of adverse events (AEs).
Safety and tolerability.
Measured: 0 hour to 8 days after dosing.
Incidence of serious adverse events (SAEs).
Safety and tolerability.
Measured: 0 hour to 8 days after dosing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start13 Jan 2026
- Primary completion4 Aug 2026
- Study completion4 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiasStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- The Pharmacokinetics (PK), safety and Pharmacodynamics (PD) characteristics of a single oral administration of HRS-1301 tablets in subjects with mild, moderate and severe renal insufficiency and healthy subjects were compared using a single-dose, open-label design.
- Masking
- None (open label)
- Enrolment
- 36 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
- NCT07322016
- Sponsor's protocol ID
- HRS-1301-103
- Status last verified
- Sep 2026
- First submitted
- 19 Dec 2025
- Last updated
- 30 Sep 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 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-dose, Open-label Phase I Clinical Trial Comparing the Pharmacokinetics, Safety and Pharmacodynamics of HRS-1301 Tablets in Subjects With Mild, Moderate and Severe Renal Insufficiency and Healthy Subjects
- ClinicalTrials.gov ID
- NCT07322016
- Acronym / sponsor ID
- HRS-1301-103
- Conditions
- Hyperlipidemias
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Jan 2026 (actual)
- Primary completion
- 4 Aug 2026 (actual)
- Study completion
- 4 Aug 2026 (actual)
- First posted
- 7 Jan 2026 (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 of this study is to evaluate pharmacokinetics of HRS-1301 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The Pharmacokinetics (PK), safety and Pharmacodynamics (PD) characteristics of a single oral administration of HRS-1301 tablets in subjects with mild, moderate and severe renal insufficiency and healthy subjects were compared using a single-dose, open-label design.
| Arm | Type | Receives |
|---|---|---|
| HRS-1301 Tablet Group | Experimental | Drug: HRS-1301 TabletTreatment for oral medication. |
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 18 kg/m2 to 30 kg/m2 (including 18 and 30),and Male weight ≥ 50.0 kg, female weight ≥ 45.0 kg;
- 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; Subjects with severe renal function impairment: 15~29 mL/min.
Key exclusion criteria (11 listed)
- Individuals with a specific history of allergies (such as asthma, urticaria, eczema, etc.), or those with an allergic constitution (such as those allergic to any drug or food), or those known to be allergic to any component of the studied drug;
- Those with cardiogenic shock, severe conduction obstruction, sick sinus syndrome, heart failure (NYHA grade III-IV), persistent rapid arrhythmia, tortuous ventricular tachycardia or ventricular tachycardia at the pointed point, a history of clinically significant T-wave changes, myocardial infarction, or angina pectoris;
- Suffering from malignant tumors, or having a history of malignant tumors within 5 years prior to screening (excluding skin non-melanomas that have been treated without recurrence signs and resected cervical intraepithelial neoplasia);
- Those with a history of gastric or intestinal surgery that some researchers believe may affect drug absorption;
- Those who have suffered severe trauma or undergone major surgical operations within the three months prior to screening, or who plan to undergo surgery during the trial period;
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-1301 TabletHRS-1301 tablet, oral medication. | Drug | HRS-1301 Tablet Group |
Primary outcome
Maximum concentration (Cmax).
Time frame: 0 hour to 8 days after dosing.
Pharmacokinetic parameters of HRS-1301 in plasma.
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last).
Time frame: 0 hour to 8 days after dosing.
Pharmacokinetic parameters of HRS-1301 in plasma.
Area under the concentration-time curve from time zero to infinity (AUC0-inf).
Time frame: 0 hour to 8 days after dosing.
Pharmacokinetic parameters of HRS-1301 in plasma.
9 secondary outcomes
Time of maximum concentration (Tmax).
Time frame: 0 hour to 8 days after dosing.
Area under the concentration-time curve from time zero to the end of the dosing interval tau (AUC0-tau).
Time frame: 0 hour to 8 days after dosing.
Elimination half-life (t1/2).
Time frame: 0 hour to 8 days after dosing.
Apparent clearance (CL/F).
Time frame: 0 hour to 8 days after dosing.
Apparent volume of distribution (Vz/F).
Time frame: 0 hour to 8 days after dosing.
Cumulative drug excretion in urine (Ae,urine).
Time frame: 0 hour to 6 days after dosing.
Cumulative drug excretion fraction in urine (fe,urine).
Time frame: 0 hour to 6 days after dosing.
Incidence of adverse events (AEs).
Time frame: 0 hour to 8 days after dosing.
Incidence of serious adverse events (SAEs).
Time frame: 0 hour to 8 days after 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 30 Sep 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-1301 Tablet in people with Hyperlipidemias, 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 11 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 30 Sep 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?
Maximum concentration (Cmax). (time frame: 0 hour to 8 days after 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 30 Sep 2026.