NCT06855147CompletedPhase 1
Mass Balance Study of [14C]HRS9531 in Healthy Male Subjects
A Single-center, Open-label, Phase Ⅰ Clinical Study of the Absorption, Metabolism, and Excretion of [14C]HRS9531 in Healthy Male Subjects
Source: ClinicalTrials.gov · Last updated 4 Jul 2025
Brief summary (registry, in English)
This study was a single-center, single-dose, open-label study in healthy male subjects to investigate the absorption, metabolism and excretion of HRS9531 after a single subcutaneous injection of \[14C\]HRS9531.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 7 (actual)
- First submitted
- 25 Feb 2025
- Start date
- 21 Apr 2025
- Primary completion date
- 17 Jun 2025
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
- Diseases
- Type 2 diabetes
- NCT number
- NCT06855147
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 7
- From 21 Apr 2025 to the primary completion date, 17 Jun 2025
- 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.
Other illness
- History of any clinically important disease or disorder.
- History of drug or other allergies, or who, in the judgement of the investigator, may be allergic to the study drug or any component of the study drug.
Lab values
- Physical examination, vital signs or other laboratory measurements, other electrocardiographic parameters, abdominal ultrasound (except mild fatty liver), and abnormalities on chest radiography as judged by the investigator to be clinically significant.
Other
- The subject was considered by the investigator to have any other factors that would preclude him from participating in the study or the subject withdrew from the study due to his own reasons.
Who the study is looking for
- Sign the informed consent form prior to the trial and have a full understanding of the trial's procedures, content and potential adverse reactions.
- Healthy male subjects aged between 18 and 55 years (inclusive), determined at the time of signing the informed consent.
- Body weight ≥50 kg, and the body mass index (BMI) between 19 to 32.5 kg/m2.
- From the signing of the informed consent form until 12 months after the last administration, the subject (including partner) has no family planning and is willing to use the high-efficiency contraceptive measures specified in the plan.
Age in the registry: 18 years to 55 years · Sex: Male · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.