Actively Recruiting
Phase I Study to Assess Safety and Effects of Oral HRS-7156 Doses in Healthy Adults Aged 18 to 55
Led by Shandong Suncadia Medicine Co., Ltd. · Updated on 2026-06-29
66
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a Phase I clinical trial to study HRS-7156 in healthy adults aged 18 to 55 years. The study aims to evaluate the safety, tolerability, how the body processes the drug pharmacokinetics, and how the drug affects the body pharmacodynamics in people without heart failure or other significant health conditions. This trial is important to understand how HRS-7156 behaves in healthy individuals before testing in patients with heart failure. Participants will receive either HRS-7156 or a placebo in a randomized, quadruple-masked design. The study includes single and multiple ascending oral doses of the drug. The dosing schedule and exact amounts are determined by the study protocol. The trial will also assess the effect of food on how the drug is absorbed and processed. Participants will take the doses over a defined period, with monitoring throughout. During the trial, participants will undergo regular assessments including safety checks for adverse events up to 14 days, blood tests to measure drug levels and kidney clearance from Day 1 to Day 9, and tests to evaluate the drugs effects on renin concentration. Participants will be monitored closely for any side effects or reactions. The total participation lasts for the duration of the dosing and follow-up periods, concluding by July 2026.
CONDITIONS
Brief Title
A Clinical Study of HRS-7156 in Healthy Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy men and women aged 18 to 55 years at informed consent signing
- Male body weight at least 50 kg, female at least 45 kg
- Body mass index between 18.5 and 30 kg/m² at screening and baseline
- No clinically significant abnormalities at screening and baseline
- Fertile females and males with fertile female partners must use effective contraception from 2 weeks before consent until 1 week after last dose; no sperm or egg donation
You will not qualify if you...
- History or current severe diseases of multiple systems or other diseases that may affect trial results
- Severe infection, trauma, or major surgery within 3 months before screening or planned surgery during trial
- Blood donation or severe blood loss (≥400 mL) within 8 weeks or blood transfusion within 4 weeks before screening; planned blood donation during trial
- History of drug abuse or dependence; positive urine drug test at screening
- Participation in other clinical trials within 3 months before screening or planned participation during trial
- Smoking ≥5 cigarettes/day within 4 weeks before screening or inability to abstain during trial; positive smoke test at screening or baseline
- Positive for HBsAg, HIV antibody, Treponema pallidum antibody, or HCV antibody at screening
- Special dietary requirements or inability to comply with the unified diet
- Difficulty swallowing or venous blood collection; intolerance to intensive blood sampling
- Other conditions deemed unsuitable for participation by the researcher
Research Team
K
Kaiyun Zhang
S
Sheng Qi
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