HyperlipidemiasPhase 1NCT07608705

A Study to Assess the Effect of HRS-1301 on the Pharmacokinetics of Midazolam and Atorvastatin in Healthy Participants

A Phase 1 study testing HRS-1301 Tablets, Atorvastatin Calcium Tablets and Midazolam oral solution in people with Hyperlipidemias, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Hyperlipidemias
What is being tested?: HRS-1301 Tablets, Atorvastatin Calcium Tablets and Midazolam oral solution
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: 8 Jun 2026to 24 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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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;
Subjects who understand the study procedures and methods, voluntarily agree to participate in this trial, and provide written informed consent (ICF).

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

China1 site

Qilu Hospital of Shandong University
Jinan, Shandong, 250012

Other trials in China

About this study

Official title: An Open-label, Single-arm, Fixed-sequence Phase I Clinical Trial to Evaluate the Effect of HRS-1301 Tablets on the Pharmacokinetics of Midazolam and Atorvastatin Calcium Tablets in Healthy Participants

Conditions: Hyperlipidemias
Being tested: HRS-1301 Tablets, Atorvastatin Calcium Tablets, Midazolam oral solution
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.
Atorvastatin Calcium TabletsDrug
Atorvastatin Calcium tablets.
Midazolam oral solutionDrug
Midazolam oral solution.

Study groups in NCT07608705
Study group	Role	What they receive
HRS-1301 and Midazolam or Atorvastatin Group	Experimental	HRS-1301 tablets and Midazolam oral solution or Atorvastatin Calcium tablets, specified dose on specified days. Receives: Drug: HRS-1301 Tablets; Drug: Atorvastatin Calcium Tablets; Drug: Midazolam oral solution

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum observed plasma concentration (Cmax)
Plasma pharmacokinetics (PK) parameters of Midazolam when administered alone and in combination with HRS-1301 tablets.
Measured: Up to 15 days.
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC 0-last)
Plasma pharmacokinetics (PK) parameters of Midazolam when administered alone and in combination with HRS-1301 tablets.
Measured: Up to 15 days.
Area under the plasma concentration-time curve from time 0 to infinity (AUC 0-inf)
Plasma pharmacokinetics (PK) parameters of Midazolam when administered alone and in combination with HRS-1301 tablets.
Measured: Up to 15 days.
Maximum observed plasma concentration (Cmax)
Plasma pharmacokinetics (PK) parameters of Atorvastatin when administered alone and in combination with HRS-1301 tablets.
Measured: Up to 18 days.
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC0-last)
Plasma pharmacokinetics (PK) parameters of Atorvastatin when administered alone and in combination with HRS-1301 tablets.
Measured: Up to 18 days.
Area under the plasma concentration-time curve from time 0 to infinity (AUC 0-inf)
Plasma pharmacokinetics (PK) parameters of Atorvastatin when administered alone and in combination with HRS-1301 tablets.
Measured: Up to 18 days.

Secondary outcomes (15)

Time to reach maximum observed concentration (Tmax)
Plasma pharmacokinetics (PK) parameters of Midazolam and 1-hydroxymidazolam when administered alone and in combination with HRS-1301 tablets.
Measured: Up to 15 days.
Terminal elimination half-life (t1/2)
Plasma pharmacokinetics (PK) parameters of Midazolam and 1-hydroxymidazolam when administered alone and in combination with HRS-1301 tablets.
Measured: Up to 15 days.
Apparent clearance (CL/F)
Plasma pharmacokinetics (PK) parameters of Midazolam and 1-hydroxymidazolam when administered alone and in combination with HRS-1301 tablets.
Measured: Up to 15 days.
Apparent volume of distribution (Vz/F)
Plasma pharmacokinetics (PK) parameters of Midazolam 1-hydroxymidazolam when administered alone and in combination with HRS-1301 tablets.
Measured: Up to 15 days.
Maximum observed plasma concentration (Cmax)
Plasma pharmacokinetics (PK) parameters of 1-hydroxymidazolam following administration of midazolam alone and in combination with HRS-1301 tablets.
Measured: Up to 15 days.
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC 0-last)
Plasma pharmacokinetics (PK) parameters of 1-hydroxymidazolam following administration of midazolam alone and in combination with HRS-1301 tablets.
Measured: Up to 15 days.
Area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf)
Plasma pharmacokinetics (PK) parameters of 1-hydroxymidazolam following administration of midazolam alone and in combination with HRS-1301 tablets.
Measured: Up to 15 days.
Apparent volume of distribution (Vz/F)
Plasma pharmacokinetics (PK) parameters of Atorvastatin and 2-Hydroxy Atorvastatin when administered alone and in combination with HRS-1301 tablets.
Measured: Up to 18 days.
Apparent clearance (CL/F)
Plasma pharmacokinetics (PK) parameters of Atorvastatin and 2-Hydroxy Atorvastatin when administered alone and in combination with HRS-1301 tablets.
Measured: Up to 18 days.
Time to reach maximum observed concentration (Tmax)
Plasma pharmacokinetics (PK) parameters of Atorvastatin 2-Hydroxy Atorvastatin when administered alone and in combination with HRS-1301 tablets.
Measured: Up to 18 days.
Terminal elimination half-life (t1/2)
Plasma pharmacokinetics (PK) parameters of Atorvastatin and 2-Hydroxy Atorvastatin when administered alone and in combination with HRS-1301 tablets.
Measured: Up to 18 days.
Maximum observed plasma concentration (Cmax)
Plasma pharmacokinetics (PK) parameters of 2-Hydroxy Atorvastatin following administration of atorvastatin alone and in combination with HRS-1301 tablets.
Measured: Up to 18 days.
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC 0-last)
Plasma pharmacokinetics (PK) parameters of 2-Hydroxy Atorvastatin following administration of atorvastatin alone and in combination with HRS-1301 tablets.
Measured: Up to 18 days.
Area under the plasma concentration-time curve from time 0 to infinity (AUC 0-inf)
Plasma pharmacokinetics (PK) parameters of 2-Hydroxy Atorvastatin following administration of atorvastatin alone and in combination with HRS-1301 tablets.
Measured: Up to 18 days.
Incidence and severity of adverse events (AEs)
Safety and Tolerability.
Measured: Up to 22 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Jun 202624 Aug 2026

First posted27 May 2026
Study start8 Jun 2026
Primary completion24 Aug 2026
Study completion24 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: An open-label, single-arm, fixed-sequence, pharmacokinetics, safety and tolerability study.
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07608705
Sponsor's protocol ID: HRS-1301-105
Status last verified: Sep 2026
First submitted: 20 May 2026
Last updated: 30 Sep 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia

All Hyperlipidemias trials

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: An Open-label, Single-arm, Fixed-sequence Phase I Clinical Trial to Evaluate the Effect of HRS-1301 Tablets on the Pharmacokinetics of Midazolam and Atorvastatin Calcium Tablets in Healthy Participants
ClinicalTrials.gov ID: NCT07608705
Acronym / sponsor ID: HRS-1301-105
Conditions: Hyperlipidemias
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: 8 Jun 2026 (actual)
Primary completion: 24 Aug 2026 (actual)
Study completion: 24 Aug 2026 (actual)
First posted: 27 May 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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: An open-label, single-arm, fixed-sequence, pharmacokinetics, safety and tolerability study.

Arm	Type	Receives
HRS-1301 and Midazolam or Atorvastatin Group	Experimental	Drug: HRS-1301 Tablets, Drug: Atorvastatin Calcium Tablets, Drug: Midazolam oral solutionHRS-1301 tablets and Midazolam oral solution or Atorvastatin Calcium tablets, specified dose on specified days.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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;
Subjects who understand the study procedures and methods, voluntarily agree to participate in this trial, and provide written informed consent (ICF).

Key exclusion criteria (8 listed)

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;

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	HRS-1301 and Midazolam or Atorvastatin Group
Atorvastatin Calcium TabletsAtorvastatin Calcium tablets.	Drug	HRS-1301 and Midazolam or Atorvastatin Group
Midazolam oral solutionMidazolam oral solution.	Drug	HRS-1301 and Midazolam or Atorvastatin Group

Primary outcome

Maximum observed plasma concentration (Cmax)
Time frame: Up to 15 days.
Plasma pharmacokinetics (PK) parameters of Midazolam when administered alone and in combination with HRS-1301 tablets.
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC 0-last)
Time frame: Up to 15 days.
Plasma pharmacokinetics (PK) parameters of Midazolam when administered alone and in combination with HRS-1301 tablets.
Area under the plasma concentration-time curve from time 0 to infinity (AUC 0-inf)
Time frame: Up to 15 days.
Plasma pharmacokinetics (PK) parameters of Midazolam when administered alone and in combination with HRS-1301 tablets.
Maximum observed plasma concentration (Cmax)
Time frame: Up to 18 days.
Plasma pharmacokinetics (PK) parameters of Atorvastatin when administered alone and in combination with HRS-1301 tablets.
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC0-last)
Time frame: Up to 18 days.
Plasma pharmacokinetics (PK) parameters of Atorvastatin when administered alone and in combination with HRS-1301 tablets.
Area under the plasma concentration-time curve from time 0 to infinity (AUC 0-inf)
Time frame: Up to 18 days.
Plasma pharmacokinetics (PK) parameters of Atorvastatin when administered alone and in combination with HRS-1301 tablets.

15 secondary outcomes

Time to reach maximum observed concentration (Tmax)
Time frame: Up to 15 days.
Terminal elimination half-life (t1/2)
Time frame: Up to 15 days.
Apparent clearance (CL/F)
Time frame: Up to 15 days.
Apparent volume of distribution (Vz/F)
Time frame: Up to 15 days.
Maximum observed plasma concentration (Cmax)
Time frame: Up to 15 days.
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC 0-last)
Time frame: Up to 15 days.
Area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf)
Time frame: Up to 15 days.
Apparent volume of distribution (Vz/F)
Time frame: Up to 18 days.
Apparent clearance (CL/F)
Time frame: Up to 18 days.
Time to reach maximum observed concentration (Tmax)
Time frame: Up to 18 days.
Terminal elimination half-life (t1/2)
Time frame: Up to 18 days.
Maximum observed plasma concentration (Cmax)
Time frame: Up to 18 days.
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC 0-last)
Time frame: Up to 18 days.
Area under the plasma concentration-time curve from time 0 to infinity (AUC 0-inf)
Time frame: Up to 18 days.
Incidence and severity of adverse events (AEs)
Time frame: Up to 22 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 30 Sep 2026.
Individual participant dataSharing planned: Undecided

Related trials for Hyperlipidemias

Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia

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, Atorvastatin Calcium Tablets and Midazolam oral solution 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 5 inclusion and 8 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 observed plasma concentration (Cmax) (time frame: Up to 15 days.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07608705.

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.