Scientists trace heart failure drug's path through the body
NCT ID NCT07681479
First seen Jul 02, 2026 · Last updated Sep 11, 2026 · Updated 2 times
Summary
This Phase 1 trial investigates how the drug HRS-9057 is absorbed, processed, and eliminated in healthy men. Six participants receive a single dose, and researchers measure the drug and its breakdown products in blood, urine, and stool. The goal is to understand the drug's behavior in the body, which is a key step before testing it in people with fluid retention due to heart failure.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HRS-9057
- What this could lead to
- If successful, this study could help determine the right dosing and safety of HRS-9057 for treating fluid retention in heart failure.
- What could go wrong
- This is a very early, small study in just 6 healthy people, not patients. It focuses on drug metabolism, not on whether the drug works for the condition.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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6 people
The number who actually took part.
- Started
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Aug 2026
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 45 years
- Sex
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Male participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Informed consent was obtained voluntarily 2. Healthy males aged 18 \~ 45 years (inclusive) 3. Body weight ≥50 kg, BMI 19 \~ 28 kg/m2 (inclusive) 4. Adopt efficient contraceptive measures Exclusion Criteria: 1. Have a history of drug allergy, specific allergy, or allergic constitution 2. Any previous or current medical history that may affect the safety of the participant in the trial or the course of the study drug in vivo 3. Have a history of risk factors for torsade de pointes 4. During the screening period, serum potassium, sodium, ALT, or AST were beyond the normal range, or the calculated eGFR was less than 90 mL/min/1.73m2 5. During screening, 12-lead ECG showed atrioventricular block, atrial fibrillation or flutter, QTcF≥450 ms 6. Chest X-ray findings deemed clinically significant by the investigator 7. Have positive test results for hepatitis B surface antigen, hepatitis C virus antibody, or treponema pallidum antibody or nonnegative test result for human immunodeficiency virus (HIV) during the screening period 8. Have used or are using any prescription or over-the-counter drugs within 2 weeks before the dosing 9. Any drug that inhibits or induces hepatic drug-metabolizing enzymes within 4 weeks prior to administration 10. All kinds of voiding disorders (such as frequent urination, dysuria, etc.), habitual constipation or diarrhea 11. Workers engaged in conditions requiring long-term exposure to radioactivity; Or had significant radiation exposure (≥2 chest/abdominal CT scans, or ≥3 other types of X-ray examinations) within 1 year before the trial or had participated in a radiolabeled drug trial within 1 year 12. Participants may have been unable to complete the study for other reasons or may have been deemed by the investigator to be unsuitable for enrollment
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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First Affiliated Hospital With Nanjing Medical University (Jiangsu Province Hospital )
Nanjing, Jiangsu, 210036, China