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RecruitingNCT07608705Updated Jun 16, 2026

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

A Phase 1 interventional study of HRS-1301 Tablets and Atorvastatin Calcium Tablets in Hyperlipidemias, sponsored by Shandong Suncadia Medicine Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-16.

Sponsored by Shandong Suncadia Medicine Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
16
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hyperlipidemias

Browse trials for

03

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
16 participants (estimated)

Study arms

  • Experimental
    HRS-1301 and Midazolam or Atorvastatin Group

    HRS-1301 tablets and Midazolam oral solution or Atorvastatin Calcium tablets, specified dose on specified days.

    Drug: HRS-1301 Tablets · Drug: Atorvastatin Calcium Tablets · Drug: Midazolam oral solution

Interventions

  • DrugHRS-1301 Tablets

    HRS-1301 tablets.

  • DrugAtorvastatin Calcium Tablets

    Atorvastatin Calcium tablets.

  • DrugMidazolam oral solution

    Midazolam oral solution.

05

What researchers measure

Primary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Plasma pharmacokinetics (PK) parameters of Midazolam when administered alone and in combination with HRS-1301 tablets.

    Time frame: Up to 15 days.

  2. 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.

    Time frame: Up to 15 days.

  3. 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.

    Time frame: Up to 15 days.

  4. Maximum observed plasma concentration (Cmax)

    Plasma pharmacokinetics (PK) parameters of Atorvastatin when administered alone and in combination with HRS-1301 tablets.

    Time frame: Up to 18 days.

  5. 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.

    Time frame: Up to 18 days.

  6. 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.

    Time frame: Up to 18 days.

Secondary outcomes

  1. 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.

    Time frame: Up to 15 days.

  2. 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.

    Time frame: Up to 15 days.

  3. Apparent clearance (CL/F)

    Plasma pharmacokinetics (PK) parameters of Midazolam and 1-hydroxymidazolam when administered alone and in combination with HRS-1301 tablets.

    Time frame: Up to 15 days.

  4. Apparent volume of distribution (Vz/F)

    Plasma pharmacokinetics (PK) parameters of Midazolam 1-hydroxymidazolam when administered alone and in combination with HRS-1301 tablets.

    Time frame: Up to 15 days.

  5. Maximum observed plasma concentration (Cmax)

    Plasma pharmacokinetics (PK) parameters of 1-hydroxymidazolam following administration of midazolam alone and in combination with HRS-1301 tablets.

    Time frame: Up to 15 days.

  6. 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.

    Time frame: Up to 15 days.

  7. 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.

    Time frame: Up to 15 days.

  8. 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.

    Time frame: Up to 18 days.

  9. Apparent clearance (CL/F)

    Plasma pharmacokinetics (PK) parameters of Atorvastatin and 2-Hydroxy Atorvastatin when administered alone and in combination with HRS-1301 tablets.

    Time frame: Up to 18 days.

  10. 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.

    Time frame: Up to 18 days.

  11. 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.

    Time frame: Up to 18 days.

  12. 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.

    Time frame: Up to 18 days.

  13. 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.

    Time frame: Up to 18 days.

  14. 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.

    Time frame: Up to 18 days.

  15. Incidence and severity of adverse events (AEs)

    Safety and Tolerability.

    Time frame: Up to 22 days.

06

Study locations

1 of 1 sites recruiting
  • Qilu Hospital of Shandong University
    Jinan, Shandong 250012, China
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07608705
Lead sponsor
Shandong Suncadia Medicine Co., Ltd.
Responsible party
Sponsor
First posted
May 27, 2026
Start date
Jun 8, 2026
Primary completion
Aug 2026 (estimated)
Completion
Aug 2026 (estimated)
Last update
Jun 16, 2026

Study contacts

Ying Wang
Contact
ying.wang.yw30@hengrui.com
+86-0518-82342973

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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