Fluid Retention Due to Heart FailurePhase 1NCT07681479

A Mass Balance Study of [14C]HRS-9057 for Injection in Healthy Participants

A Phase 1 study testing [14C]HRS-9057 in people with Fluid Retention Due to Heart Failure, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

This study is a single-center, open-label, single-dose phase I clinical trial. The trial is divided into four periods: screening, baseline, treatment, and follow-up Read more about this study

Who is it for?: Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Fluid Retention Due to Heart Failure
What is being tested?: [14C]HRS-9057
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteChina
Study dates: 11 Aug 2026to Dec 2026
Phase: Phase 1
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Informed consent was obtained voluntarily
Healthy males aged 18 ~ 45 years (inclusive)
Body weight ≥50 kg, BMI 19 ~ 28 kg/m2 (inclusive)
Adopt efficient contraceptive measures

Who cannot join

Have a history of drug allergy, specific allergy, or allergic constitution
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
Have a history of risk factors for torsade de pointes
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
During screening, 12-lead ECG showed atrioventricular block, atrial fibrillation or flutter, QTcF≥450 ms
Chest X-ray findings deemed clinically significant by the investigator

Show all 12Show fewer

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
Have used or are using any prescription or over-the-counter drugs within 2 weeks before the dosing
Any drug that inhibits or induces hepatic drug-metabolizing enzymes within 4 weeks prior to administration
All kinds of voiding disorders (such as frequent urination, dysuria, etc.), habitual constipation or diarrhea
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
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

Trial locations and contacts

1 site in 1 country.

China1 site

First Affiliated Hospital With Nanjing Medical University (Jiangsu Province Hospital )
Nanjing, Jiangsu, 210036

Other trials in China

About this study

This study is a single-center, open-label, single-dose phase I clinical trial. The trial is divided into four periods: screening, baseline, treatment, and follow-up

Conditions: Fluid Retention Due to Heart Failure
Being tested: [14C]HRS-9057

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

[14C]HRS-9057Drug
[14C]HRS-9057

Study groups in NCT07681479
Study group	Role	What they receive
Dose Level：A	Experimental	Subject will receive [14C]HRS-9057 at dose level A Receives: Drug: [14C]HRS-9057

What is being measured

The primary outcome is the main question the study is designed to answer.

Total radioactivity recovery and cumulative total radioactivity recovery in urine and feces during each collection period
Measured: From Day 1 to Day 28
Percentage of HRS-9057 parent drug and its metabolites in plasma relative to the total radioactivity exposure in plasma (%AUC)
Measured: From Day 1 to Day 8
The percentage of HRS-9057 parent drug and its metabolites in urine and feces relative to the administered dose (%Dose)
Measured: From Day 1 to Day 28
Pharmacokinetic parameter of total radioactivity in whole blood and plasma, including: Tmax
Measured: From Day 1 to Day 28
Pharmacokinetic parameter of total radioactivity in whole blood and plasma, including: Cmax
Measured: From Day 1 to Day 28
Pharmacokinetic parameter of total radioactivity in whole blood and plasma, including: t1/2
Measured: From Day 1 to Day 28
Pharmacokinetic parameter of total radioactivity in whole blood and plasma, including: MRT
Measured: From Day 1 to Day 28
Pharmacokinetic parameter of total radioactivity in whole blood and plasma, including: AUC
Measured: From Day 1 to Day 28

Secondary outcomes (6)

Pharmacokinetic parameter of HRS-9057, and other major metabolites (if applicable) in plasma, including: Tmax
Measured: From Day 1 to Day 28
Pharmacokinetic parameter of HRS-9057, and other major metabolites (if applicable) in plasma, including: Cmax
Measured: From Day 1 to Day 28
Pharmacokinetic parameter of HRS-9057, and other major metabolites (if applicable) in plasma, including: t1/2
Measured: From Day 1 to Day 28
Pharmacokinetic parameter of HRS-9057, and other major metabolites (if applicable) in plasma, including: MRT
Measured: From Day 1 to Day 28
Pharmacokinetic parameter of HRS-9057, and other major metabolites (if applicable) in plasma, including: AUC
Measured: From Day 1 to Day 28
Serious adverse events
Measured: From ICF signing date to Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Aug 2026Dec 2026

First posted2 Jul 2026
Study start11 Aug 2026
Primary completion11 Aug 2026
Study completionDec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Fluid Retention Due to Heart FailureStudies of the same condition, open and under way.
More trials run by Fujian Shengdi Pharmaceutical Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07681479
Sponsor's protocol ID: HRS-9057-105
Status last verified: Jun 2026
First submitted: 23 Jun 2026
Last updated: 10 Sep 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Study at a glance

From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Mass Balance Study of [14C]HRS-9057 for Injection in Healthy Participants
ClinicalTrials.gov ID: NCT07681479
Acronym / sponsor ID: HRS-9057-105
Conditions: Fluid Retention Due to Heart Failure
Phase: Phase 1
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 6 participants (actual)
Lead sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 11 Aug 2026 (actual)
Primary completion: 11 Aug 2026 (actual)
Study completion: Dec 2026 (estimated)
First posted: 2 Jul 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study is a single-center, open-label, single-dose phase I clinical trial. The trial is divided into four periods: screening, baseline, treatment, and follow-up

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Dose Level：A	Experimental	Drug: [14C]HRS-9057Subject will receive [14C]HRS-9057 at dose level A

Who may qualify

Ages: 18 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Informed consent was obtained voluntarily
Healthy males aged 18 ~ 45 years (inclusive)
Body weight ≥50 kg, BMI 19 ~ 28 kg/m2 (inclusive)
Adopt efficient contraceptive measures

Key exclusion criteria (12 listed)

Have a history of drug allergy, specific allergy, or allergic constitution
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
Have a history of risk factors for torsade de pointes
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
During screening, 12-lead ECG showed atrioventricular block, atrial fibrillation or flutter, QTcF≥450 ms

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
[14C]HRS-9057[14C]HRS-9057	Drug	Dose Level：A

Primary outcome

Total radioactivity recovery and cumulative total radioactivity recovery in urine and feces during each collection period
Time frame: From Day 1 to Day 28
Percentage of HRS-9057 parent drug and its metabolites in plasma relative to the total radioactivity exposure in plasma (%AUC)
Time frame: From Day 1 to Day 8
The percentage of HRS-9057 parent drug and its metabolites in urine and feces relative to the administered dose (%Dose)
Time frame: From Day 1 to Day 28
Pharmacokinetic parameter of total radioactivity in whole blood and plasma, including: Tmax
Time frame: From Day 1 to Day 28
Pharmacokinetic parameter of total radioactivity in whole blood and plasma, including: Cmax
Time frame: From Day 1 to Day 28
Pharmacokinetic parameter of total radioactivity in whole blood and plasma, including: t1/2
Time frame: From Day 1 to Day 28
Pharmacokinetic parameter of total radioactivity in whole blood and plasma, including: MRT
Time frame: From Day 1 to Day 28
Pharmacokinetic parameter of total radioactivity in whole blood and plasma, including: AUC
Time frame: From Day 1 to Day 28

6 secondary outcomes

Pharmacokinetic parameter of HRS-9057, and other major metabolites (if applicable) in plasma, including: Tmax
Time frame: From Day 1 to Day 28
Pharmacokinetic parameter of HRS-9057, and other major metabolites (if applicable) in plasma, including: Cmax
Time frame: From Day 1 to Day 28
Pharmacokinetic parameter of HRS-9057, and other major metabolites (if applicable) in plasma, including: t1/2
Time frame: From Day 1 to Day 28
Pharmacokinetic parameter of HRS-9057, and other major metabolites (if applicable) in plasma, including: MRT
Time frame: From Day 1 to Day 28
Pharmacokinetic parameter of HRS-9057, and other major metabolites (if applicable) in plasma, including: AUC
Time frame: From Day 1 to Day 28
Serious adverse events
Time frame: From ICF signing date to Day 28

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
Individual participant dataSharing planned: Undecided

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [14C]HRS-9057 in people with Fluid Retention Due to Heart Failure, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total radioactivity recovery and cumulative total radioactivity recovery in urine and feces during each collection period (time frame: From Day 1 to Day 28). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07681479.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.