A Clinical Study of HRS-7156 in Healthy Participants

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of Single and Multiple Ascending Oral Doses of HRS-7156 in Healthy Participants

The purpose of this Phase I study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-7156 in healthy participants.

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Drug: HRS-7156; Drug: HRS-7156 placebo

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Kaiyun Zhang; Phone Number: +86-0518-82342973; Email: kaiyun.zhang.kz38@hengrui.com
• Study Contact Backup: Name: Sheng Qi; Phone Number: +86-0518-82342973; Email: sheng.qi@hengrui.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200032
      • Zhongshan Hospital Affiliated to Fudan University
      • Principal Investigator: Xuening Li
      • Contact: Xuening Li; Phone Number: +86-021-31587862; Email: li.xuening@zs-hospital.sh.cn

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Healthy men and women aged 18 to 55 years old at informed consent signing;
2. Male body weight ≥50 kg, female ≥45 kg; BMI 18.5 to 30 kg/m² at screening and baseline;
3. Have no clinically significant abnormalities at screening and baseline;
4. Fertile females and males with fertile female partners: effective contraception 2 weeks before consent, and sustained until 1 week after the last dose (abstinence or highly effective contraception); no sperm/egg donation.

Exclusion Criteria:

1. A history or current severe diseases of multiple systems, or other diseases interfering with trial results;
2. Severe infection, trauma, major surgery within 3 months before screening; planned surgery during the trial;
3. Blood donation/severe blood loss (≥400 mL) within 8 weeks, blood transfusion within 4 weeks before screening; planned blood donation during the trial;
4. History of drug abuse/dependence; positive urine drug test at screening.Participation in other clinical trials within 3 months before screening or planned;
5. participation during the trial; within 5 half-lives of a prior drug (whichever is longer);
6. Smoking history (≥5 cigarettes/day) within 4 weeks before screening; inability to abstain from tobacco during the trial; positive smoke screening at screening/baseline;
7. Positive for HBsAg, HIV antibody, Treponema pallidum antibody or HCV antibody at screening;
8. Special dietary requirements and inability to comply with the unified diet;
9. Difficulty in swallowing/venous blood collection; intolerance to intensive blood sampling;
10. Other circumstances deemed unsuitable for trial participation by Researcher.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HRS-7156	Drug: HRS-7156; HRS-7156, specified dose on specified day.
Placebo Comparator: HRS-7156 placebo	Drug: HRS-7156 placebo; HRS-7156 placebo, specified dose on specified day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse event (AE) and serious adverse event (SAE)	Safety: Incidence of adverse event (AE) and serious adverse event (SAE).	Up to 14 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the concentration time curve (AUC)	Pharmacokinetics (PK) parameter of HRS-7156.	Day 1 - Day 9.
Maximum Plasma Concentration (Cmax)	Pharmacokinetics (PK) parameter of HRS-7156.	Day 1 - Day 9.
Time to maximum plasma concentration (Tmax)	Pharmacokinetics (PK) parameter of HRS-7156.	Day 1 - Day 9.
Renal clearance (CLR)	Pharmacokinetics (PK) parameter of HRS-7156.	Day 1 - Day 2.
Renin concentration of HRS-7156	Pharmacodynamics (PD) endpoint of HRS-7156.	Day 1 - Day 9.

Collaborators and Investigators

• Sponsor: Shandong Suncadia Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: May 15, 2026
• First Submitted That Met QC Criteria: May 15, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: HRS-7156-101

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