HyperlipidemiaPhase 1NCT07097831
A Clinical Trial of HRS-1301 on the Pharmacokinetics of Rosuvastatin Calcium Tablets in Healthy Subjects
A Phase 1 study testing HRS-1301 Tablets and Rosuvastatin Calcium Tablets in people with Hyperlipidemia, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.
Trial summary
The study was designed to evaluate the pharmacokinetic effects of rosuvastatin calcium tablets after oral administration of HRS-1301 in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- HRS-1301 Tablets and Rosuvastatin Calcium Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 9 Oct 2025to 7 Nov 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males or females, aged 18-55 years (inclusive).
- At screening, 18.0 ≤ BMI ≤ 30 kg/m2 (inclusive), and body weight ≥ 50.0 kg and <90.0 kg for males and ≥ 45.0 kg and < 90.0 kg for females.
- Physical examination, vital signs, electrocardiogram, chest X-ray /CT, abdominal ultrasound, laboratory tests (blood routine, blood biochemistry, urine routine, coagulation function, thyroid function) were normal or abnormal but of no clinical significance.
- The female subjects were not pregnant or lactating, and the results of pregnancy tests before the test were negative. Those who did not have unprotected sex within two weeks before screening; Female subjects of childbearing potential and men whose partners were women of childbearing age agreed to comply with relevant contraceptive requirements and had no sperm/egg donation plans.
- Participants were able to communicate well with the investigators, understand and comply with the requirements of the study, and sign the informed consent form.
Who cannot join
- Previous medical history or current clinical diagnosis of cardiac, respiratory, endocrine, metabolic, cutaneous, infectious, malignant tumor, hematologic, neurological or psychiatric disorders, metabolic/functional disorders or other diseases.
- Gastrointestinal, hepatic, or renal disease, as judged by the investigator, or other conditions known to affect the absorption, distribution, metabolism, and excretion of the drug or to impair adherence.
- Patients with major trauma or surgery within 3 months before screening or planning to undergo surgery during the trial.
- Patients with specific allergic history (asthma, urticaria, eczema, etc.), or allergic constitution (such as allergic to any drug, food), or known allergic to any ingredient in the study drug.
- Participants who had used any drugs (including prescription drugs, over-the-counter drugs, herbal medicines, dietary supplements, etc., except regular vitamins and occasional acetaminophen) within 2 weeks before screening, or within 5 half-life periods of the drugs (whichever was longer).
- Enrolled in a clinical trial of any drug or medical device within 3 months before screening or within 5 half-lives of the drug before screening, whichever is longer.
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- Individuals who have donated ≥ 400 mL blood within 4 weeks before screening, have severe blood loss (blood loss ≥ 400 mL), or have received blood transfusion within 8 weeks before screening.
- Persons who are scheduled to receive live (attenuated) vaccine within 4 weeks before screening or during the course of the trial.
- Hepatitis B virus surface antigen, hepatitis C virus IgG antibody, anti-treponema pallidum antibody, human immunodeficiency virus antibody and antigen p24 positive during the screening period.
- Those with positive alcohol breath test and/or drug abuse screening test at baseline.
- A history of drug or substance abuse.
- Potential difficulty in blood collection, with a history of syncope.
- Investigators, research assistants, pharmacists, research coordinators, or others directly involved in the implementation of the protocol.
- Any factors considered by the investigator to be unsuitable for participation in the trial.
- Subjects voluntarily withdraw from the trial due to their own reasons.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215004
About this study
Official title: An Open-label, Single-arm, Fixed-sequence, Single-center Phase I Clinical Trial of HRS-1301 on the Pharmacokinetics of Rosuvastatin Calcium Tablets in Healthy Subjects
The study was designed to evaluate the pharmacokinetic effects of rosuvastatin calcium tablets after oral administration of HRS-1301 in healthy subjects.
- Conditions
- Hyperlipidemia
- Being tested
- HRS-1301 Tablets, Rosuvastatin Calcium Tablets
- 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 TabletsDrug
HRS-1301 tablets.
Rosuvastatin Calcium TabletsDrug
Rosuvastatin calcium tablets.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Not described Receives: Drug: HRS-1301 Tablets; Drug: Rosuvastatin Calcium Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve from time 0 to time t (AUC0-t)
Measured: 0 to anticipated 15 days.
Area under the curve from time 0 to time infinity (AUC0-∞)
Measured: 0 to anticipated 15 days.
Maximum concentration (Cmax)
Measured: 0 to anticipated 15 days.
Secondary outcomes (4)
Time to reach maximum concentration (Tmax)
Measured: 0 to anticipated 15 days.
Half-life (t1/2)
Measured: 0 to anticipated 15 days.
Apparent clearance (CL/F)
Measured: 0 to anticipated 15 days.
Adverse events (AEs)
Measured: Baseline up to 19 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start9 Oct 2025
- Primary completion7 Nov 2025
- Study completion7 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies 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
- Masking
- None (open label)
- Enrolment
- 16 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
- NCT07097831
- Sponsor's protocol ID
- HRS-1301-102
- Status last verified
- Jan 2026
- First submitted
- 24 Jul 2025
- Last updated
- 9 Jan 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 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-arm, Fixed-sequence, Single-center Phase I Clinical Trial of HRS-1301 on the Pharmacokinetics of Rosuvastatin Calcium Tablets in Healthy Subjects
- ClinicalTrials.gov ID
- NCT07097831
- Acronym / sponsor ID
- HRS-1301-102
- Conditions
- Hyperlipidemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Oct 2025 (actual)
- Primary completion
- 7 Nov 2025 (actual)
- Study completion
- 7 Nov 2025 (actual)
- First posted
- 31 Jul 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 study was designed to evaluate the pharmacokinetic effects of rosuvastatin calcium tablets after oral administration of HRS-1301 in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Drug: HRS-1301 Tablets, Drug: Rosuvastatin Calcium Tablets |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Males or females, aged 18-55 years (inclusive).
- At screening, 18.0 ≤ BMI ≤ 30 kg/m2 (inclusive), and body weight ≥ 50.0 kg and <90.0 kg for males and ≥ 45.0 kg and < 90.0 kg for females.
- Physical examination, vital signs, electrocardiogram, chest X-ray /CT, abdominal ultrasound, laboratory tests (blood routine, blood biochemistry, urine routine, coagulation function, thyroid function) were normal or abnormal but of no clinical significance.
- The female subjects were not pregnant or lactating, and the results of pregnancy tests before the test were negative. Those who did not have unprotected sex within two weeks before screening; Female subjects of childbearing potential and men whose partners were women of childbearing age agreed to comply with relevant contraceptive requirements and had no sperm/egg donation plans.
- Participants were able to communicate well with the investigators, understand and comply with the requirements of the study, and sign the informed consent form.
Key exclusion criteria (15 listed)
- Previous medical history or current clinical diagnosis of cardiac, respiratory, endocrine, metabolic, cutaneous, infectious, malignant tumor, hematologic, neurological or psychiatric disorders, metabolic/functional disorders or other diseases.
- Gastrointestinal, hepatic, or renal disease, as judged by the investigator, or other conditions known to affect the absorption, distribution, metabolism, and excretion of the drug or to impair adherence.
- Patients with major trauma or surgery within 3 months before screening or planning to undergo surgery during the trial.
- Patients with specific allergic history (asthma, urticaria, eczema, etc.), or allergic constitution (such as allergic to any drug, food), or known allergic to any ingredient in the study drug.
- Participants who had used any drugs (including prescription drugs, over-the-counter drugs, herbal medicines, dietary supplements, etc., except regular vitamins and occasional acetaminophen) within 2 weeks before screening, or within 5 half-life periods of the drugs (whichever was longer).
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 TabletsHRS-1301 tablets. | Drug | Treatment Group |
| Rosuvastatin Calcium TabletsRosuvastatin calcium tablets. | Drug | Treatment Group |
Primary outcome
Area under the curve from time 0 to time t (AUC0-t)
Time frame: 0 to anticipated 15 days.
Area under the curve from time 0 to time infinity (AUC0-∞)
Time frame: 0 to anticipated 15 days.
Maximum concentration (Cmax)
Time frame: 0 to anticipated 15 days.
4 secondary outcomes
Time to reach maximum concentration (Tmax)
Time frame: 0 to anticipated 15 days.
Half-life (t1/2)
Time frame: 0 to anticipated 15 days.
Apparent clearance (CL/F)
Time frame: 0 to anticipated 15 days.
Adverse events (AEs)
Time frame: Baseline up to 19 days.
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 9 Jan 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 Tablets and Rosuvastatin Calcium Tablets in people with Hyperlipidemia, 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 15 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 9 Jan 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?
Area under the curve from time 0 to time t (AUC0-t) (time frame: 0 to anticipated 15 days.). 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 9 Jan 2026.