A Study to Assess the Effect of HRS-1301 on the Pharmacokinetics of Midazolam and Atorvastatin in… (NCT07608705) | Clinical Trial Compass
RecruitingPhase 1
A Study to Assess the Effect of HRS-1301 on the Pharmacokinetics of Midazolam and Atorvastatin in Healthy Participants
China16 participantsStarted 2026-06-08
Plain-language summary
This phase I study in healthy participants aims to assess the pharmacokinetics of midazolam and atorvastatin when administered alone and in combination with HRS-1301, and to assess the safety of HRS-1301 when administered alone and in combination with midazolam or atorvastatin.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subjects must be aged ≥ 18 years and ≤ 55 years on the day of signing the informed consent form (ICF);
. 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;
. 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;
. 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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum observed plasma concentration (Cmax)
Timeframe: Up to 15 days.
2
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC 0-last)
Timeframe: Up to 15 days.
3
Area under the plasma concentration-time curve from time 0 to infinity (AUC 0-inf)
Timeframe: Up to 15 days.
4
Maximum observed plasma concentration (Cmax)
Timeframe: Up to 18 days.
5
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC0-last)
Timeframe: Up to 18 days.
6
Area under the plasma concentration-time curve from time 0 to infinity (AUC 0-inf)
. Subjects who understand the study procedures and methods, voluntarily agree to participate in this trial, and provide written informed consent (ICF).
Exclusion criteria
. 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;
. Subjects who have gastrointestinal, hepatic, renal, or other known diseases that may affect drug absorption, distribution, metabolism, or excretion, or that may reduce compliance;
. 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;
. Subjects with a history of specific allergies, or with an allergic constitution, or with known hypersensitivity to any component of the investigational drug;
. 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;
. 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;
. 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;
. 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.