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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hyperlipidemias
• Intervention / Treatment: Drug: HRS-1301 Tablets; Drug: Atorvastatin Calcium Tablets; Drug: Midazolam oral solution

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Ying Wang; Phone Number: +86-0518-82342973; Email: ying.wang.yw30@hengrui.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Qilu Hospital of Shandong University
      • Principal Investigator: Wei Zhao
      • Contact: Wei Zhao; Phone Number: +86-0531-88382006; Email: Zhao4wei2@hotmail.com
      • Contact: Shuwen Yu; Phone Number: +86-0531-82169349; Email: yaoxuebu2012@163.com
      • Principal Investigator: Shuwen Yu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; HRS-1301 tablets.; Drug: Atorvastatin Calcium Tablets; Atorvastatin Calcium tablets.; Drug: Midazolam oral solution; Midazolam oral solution.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum observed plasma concentration (Cmax)	Plasma pharmacokinetics (PK) parameters of Midazolam when administered alone and in combination with HRS-1301 tablets.	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.	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.	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.	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.	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.	Up to 18 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Up to 18 days.
Incidence and severity of adverse events (AEs)	Safety and Tolerability.	Up to 22 days.

Collaborators and Investigators

• Sponsor: Shandong Suncadia Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: May 20, 2026
• First Submitted That Met QC Criteria: May 20, 2026
• First Posted (Actual): May 27, 2026

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Dyslipidemias; Lipid Metabolism Disorders; Nutritional and Metabolic Diseases; Hyperlipidemias; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Fatty Acids; Lipids; Azoles; Benzazepines; Pyrroles; Heptanoic Acids; Benzodiazepines; Atorvastatin; Midazolam
• Other Study ID Numbers: HRS-1301-105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No