Safety test of HRS-7156 in healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1 interventional trial assessing safety, tolerability, and how the body handles HRS-7156, including pharmacokinetics and pharmacodynamics, in healthy participants. Participants receive either the active drug or a placebo in a controlled setting. The study screens for overall health, enrolls eligible volunteers, and follows them to monitor any adverse effects and how the drug behaves in the body. The trial is conducted at a single center in Shanghai under lead sponsor Shandong Suncadia Medicine Co., with strict inclusion and exclusion criteria to minimize risk. Results will inform dose selection and safety profile for future research in patients with heart failure.

Why it matters

Who can join: the full rules

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.

Where it's running

• Zhongshan Hospital Affiliated to Fudan University
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Kaiyun Zhang
• Email: kaiyun.zhang.kz38@hengrui.com
• Phone: +86-0518-82342973

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.