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Fluid Retention Due to Heart Failure / [14C]HRS-9057 · Phase 1 Trial
ClinicalTrials.gov · September 10, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 1 open-label mass balance study registration for [14C]HRS-9057, a drug candidate for fluid retention in heart failure. The trial is designed to characterize drug disposition through radioactive tracer methods in healthy participants. No results are currently posted in this registry record.
Phase 1, Interventional, Single Group, Open label, Basic Science purpose. Fluid Retention Due to Heart Failure; Male; age from 18 Years; to 45 Years; accepts healthy volunteers. Intervention: Dose Level：A. n = 6. 1 site: China.
This is a Phase 1 open-label mass balance study registration for [14C]HRS-9057, a drug candidate for fluid retention in heart failure. The trial is designed to characterize drug disposition through radioactive tracer methods in healthy participants. No results are currently posted in this registry record.
Mass balance and PK endpoints in healthy volunteers do not directly demonstrate efficacy or safety in the intended patient population (heart failure with fluid retention). No data on adverse events, tolerability, or clinical outcomes are listed as primary endpoints.
This is a preliminary pharmacokinetic and mass balance characterization study; results when available will inform whether HRS-9057 enters further clinical testing. Clinicians should await completion and publication of results before any clinical application.
Phase 1 open-label mass balance study in a small healthy cohort (n=6) designed to characterize drug disposition, not efficacy or safety, with no results yet reported in this registry record.
As stated by the source record.
Quoted from the source exactly as published.
This is a preliminary pharmacokinetic and mass balance characterization study; results when available will inform whether HRS-9057 enters further clinical testing. Clinicians should await completion and publication of results before any clinical application.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07681479). This is a study registration, not published results. Lead sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 6 participants (ACTUAL). Conditions: Fluid Retention Due to Heart Failure. Interventions: DRUG: [14C]HRS-9057. Primary outcome measures: Total radioactivity recovery and cumulative total radioactivity recovery in urine and feces during each collection period , 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) , 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) , From Day 1 to Day 28; Pharmacokinetic parameter of total radioactivity in whole blood and plasma, including: Tmax , From Day 1 to Day 28; Pharmacokinetic parameter of total radioactivity in whole blood and plasma, including: Cmax , From Day 1 to Day 28; Pharmacokinetic parameter of total radioactivity in whole blood and plasma, including: t1/2 , From Day 1 to Day 28; Pharmacokinetic parameter of total radioactivity in whole blood and plasma, including: MRT , From Day 1 to Day 28; Pharmacokinetic parameter of total radioactivity in whole blood and plasma, including: AUC , From Day 1 to Day 28. Brief 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
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.