Menu
Not yet recruiting NCT07681479

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

Phase I Interventional Fluid Retention Due to Heart Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: [14C]HRS-9057.
Who it may be relevant to
Registry conditions: Fluid Retention Due to Heart Failure. Basic parameters: 18 years — 45 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

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

Primary outcome measures

  • 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]
Secondary outcome measures (6)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

China · 1 center
  • First Affiliated Hospital With Nanjing Medical University (Jiangsu Province Hospital ) — Nanjing

Identifiers

NCT: NCT07681479 · HRS-9057-105

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗