Healthy volunteers test drug interaction – no cure, just data
NCT ID NCT07097831
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at how a new drug called HRS-1301 changes the way the body processes rosuvastatin, a common cholesterol-lowering medication. Sixteen healthy adults took both drugs so researchers could measure drug levels in the blood. The goal was purely to gather information, not to treat any disease.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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16 people
The number who actually took part.
- Started
-
Oct 2025
- Finished
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Nov 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Males or females, aged 18-55 years (inclusive). 2. 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. 3. 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. 4. 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. 5. Participants were able to communicate well with the investigators, understand and comply with the requirements of the study, and sign the informed consent form. Exclusion Criteria: 1. 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. 2. 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. 3. Patients with major trauma or surgery within 3 months before screening or planning to undergo surgery during the trial. 4. 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. 5. 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). 6. 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. 7. 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. 8. Persons who are scheduled to receive live (attenuated) vaccine within 4 weeks before screening or during the course of the trial. 9. 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. 10. Those with positive alcohol breath test and/or drug abuse screening test at baseline. 11. A history of drug or substance abuse. 12. Potential difficulty in blood collection, with a history of syncope. 13. Investigators, research assistants, pharmacists, research coordinators, or others directly involved in the implementation of the protocol. 14. Any factors considered by the investigator to be unsuitable for participation in the trial. 15. Subjects voluntarily withdraw from the trial due to their own reasons.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215004, China
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Other studies related to the condition(s) this trial covers.
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