New cholesterol Drug's safety check: will it interfere with other meds?
NCT ID NCT07608705
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial in 16 healthy adults tests whether a new drug for high cholesterol, HRS-1301, changes how the body processes two common medicines: midazolam (a sedative) and atorvastatin (a cholesterol drug). Participants will take these drugs alone and together with HRS-1301, and researchers will measure drug levels in the blood. The goal is to understand potential drug interactions before testing HRS-1301 in patients.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HRS-1301 tablets
- What this could lead to
- If successful, this study will show whether HRS-1301 changes how the body processes other drugs, helping guide safe use in future patients.
- What could go wrong
- This is a very early, small study in healthy people, not patients. It only looks at drug levels, not whether HRS-1301 works for high cholesterol.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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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About 16 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- 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
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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. Subjects must be aged ≥ 18 years and ≤ 55 years on the day of signing the informed consent form (ICF); 2. At screening, body mass index (BMI) must be ≥ 19.0 kg/m² and \< 28 kg/m², with body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females; 3. Physical examination, vital signs, electrocardiogram (ECG), posteroanterior and lateral chest X-ray/CT, abdominal ultrasound, and laboratory tests (including complete blood count, blood biochemistry, urinalysis, coagulation function, and thyroid function) were normal or abnormal but of no clinical significance; 4. Female participants must not be pregnant or lactating and must have negative pregnancy test results prior to investigational drug administration; participants must have had no unprotected sexual intercourse within two weeks prior to screening; female participants of childbearing potential and male participants with partners of childbearing potential must agree to comply with the contraception requirements for the duration specified in the protocol and have no plans to donate sperm or eggs; 5. Subjects who understand the study procedures and methods, voluntarily agree to participate in this trial, and provide written informed consent (ICF). Exclusion Criteria: 1. Subjects with previous medical history or current diagnosis of cardiovascular, respiratory, digestive, urinary, hematological, endocrine, infectious, immunological, malignant neoplastic, neurological, or psychiatric/metabolic disorders/dysfunctions, or any other disease; 2. Subjects who have gastrointestinal, hepatic, renal, or other known diseases that may affect drug absorption, distribution, metabolism, or excretion, or that may reduce compliance; 3. Subjects who have experienced severe trauma or undergone major surgery within 3 months prior to screening, or who plan to undergo surgery during the trial period; 4. Subjects with a history of specific allergies, or with an allergic constitution, or with known hypersensitivity to any component of the investigational drug; 5. Subjects who have used any medication within 2 weeks prior to screening, or who are still within 5 half-lives of any medication at the time of screening; 6. Subjects who have participated in any other clinical trial of a drug or medical device within 3 months prior to screening, or who are still within 5 half-lives of a prior investigational drug at the time of screening; 7. Subjects who have donated blood ≥ 200 mL or experienced significant blood loss (≥ 400 mL) within 4 weeks prior to screening, or who have received a blood transfusion within 8 weeks prior to screening; 8. Subjects who have received a live (attenuated) vaccine within 4 weeks prior to screening or plan to receive such a vaccine during the trial period.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Qilu Hospital of Shandong University
RECRUITINGJinan, Shandong, 250012, China
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