A Clinical Study of HRS-7156 in Healthy Participants

NCT07601087 | Not Yet Recruiting Phase 1

• 1 other identifier: HRS-7156-101
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Area under the concentration time curve (AUC)

  Day 1 - Day 9.

• Maximum Plasma Concentration (Cmax)

  Day 1 - Day 9.

• Time to maximum plasma concentration (Tmax)

  Day 1 - Day 9.

• Renal clearance (CLR)

  Day 1 - Day 2.

• Renin concentration of HRS-7156

  Day 1 - Day 9.

Study Arms (2)

HRS-7156

EXPERIMENTAL

Drug: HRS-7156

HRS-7156 placebo

PLACEBO COMPARATOR

Drug: HRS-7156 placebo

Interventions

HRS-7156 DRUG

HRS-7156, specified dose on specified day.

HRS-7156

HRS-7156 placebo DRUG

HRS-7156 placebo, specified dose on specified day.

HRS-7156 placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy men and women aged 18 to 55 years old at informed consent signing;
• Male body weight ≥50 kg, female ≥45 kg; BMI 18.5 to 30 kg/m² at screening and baseline;
• Have no clinically significant abnormalities at screening and baseline;
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Shandong Suncadia Medicine Co., Ltd.: lead

Study Sites (1)

Zhongshan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Kaiyun Zhang

CONTACT

+86-0518-82342973; kaiyun.zhang.kz38@hengrui.com

Sheng Qi

CONTACT

+86-0518-82342973; sheng.qi@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: HRS-7156 compared with placebo.

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: May 22, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

CN (1)