Clinical Trials in China / NCT07601087
Recruiting
Phase 1
A Clinical Study of HRS-7156 in Healthy Participants
NCT07601087 · tracked via the Priya Life Science China tracker
Condition(s) studied
Heart Failure
Investigational drug(s) / intervention(s)
HRS-7156HRS-7156 placebo
HRS-7156: HRS-7156, specified dose on specified day.
HRS-7156 placebo: HRS-7156 placebo, specified dose on specified day.
Study summary
The purpose of this Phase I study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-7156 in healthy participants.
Eligibility
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.
Primary outcome measure(s)
- Incidence of adverse event (AE) and serious adverse event (SAE) — Up to 14 days.
Safety: Incidence of adverse event (AE) and serious adverse event (SAE).
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Zhongshan Hospital Affiliated to Fudan University | Shanghai | Shanghai Municipality | Recruiting |
More Shandong Suncadia Medicine Co., Ltd. trials in China
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Phase I Clinical Study Evaluating the Relative Bioavailability of Different Formulations of HRS-5346 in Healthy Participants
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Other trials for the same condition
Cohort Study of Chronic Heart Failure
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07601087 on ClinicalTrials.gov ↗ ← All trials in China