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Scientists trace heart failure drug's path through the body

NCT ID NCT07681479

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

6 people

The number who actually took part.

Started

Aug 2026

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

18 to 45 years

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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

  • First Affiliated Hospital With Nanjing Medical University (Jiangsu Province Hospital )

    Nanjing, Jiangsu, 210036, China