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NCT07681479Active, not recruitingPhase 1

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

Source: ClinicalTrials.gov · Last updated 10 Sept 2026

Brief summary (registry, in English)

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

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
6 (actual)
First submitted
23 Jun 2026
Start date
11 Aug 2026
Primary completion date
11 Aug 2026
Lead sponsor
Fujian Shengdi Pharmaceutical Co., Ltd.
NCT number
NCT07681479

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 6
  • From 11 Aug 2026 to the primary completion date, 11 Aug 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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 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

Other illness

  • Have a history of drug allergy, specific allergy, or allergic constitution
  • Have a history of risk factors for torsade de pointes
  • 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
  • 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

Lab values

  • 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

Other

  • 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
  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to 45 years · Sex: Male · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
First Affiliated Hospital With Nanjing Medical University (Jiangsu Province Hospital )
Coordinator of this site? Confirm its status
NanjingChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.