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NCT06929156CompletedPhase 1

A Study of BGM0504 in Healthy Participants and Participants With Impaired Renal Function

A Multi-center, Single-dose, Open-label, Parallel Design, Pharmacokinetics Study of BGM0504 Injection in Healthy Participants and Participants With Impaired Renal Function

Source: ClinicalTrials.gov · Last updated 13 Oct 2026

Brief summary (registry, in English)

The purpose of this study is to assess how fast BGM0504 gets into the blood stream and how long it takes the body to remove it in participants with impaired kidney function compared to healthy participants.

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
34 (actual)
First submitted
8 Apr 2025
Start date
6 May 2025
Primary completion date
25 Dec 2025
Lead sponsor
BrightGene Bio-Medical Technology Co., Ltd.
NCT number
NCT06929156

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 34
  • From 6 May 2025 to the primary completion date, 25 Dec 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.

Prior treatment

  • ● Allergic constitution includes severe drug allergy or history of drug allergy;
    • Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2; Have a history or presence of pancreatitis;
    • Participants in clinical trials of any drug or medical device in the 3 months prior to screening;.
    • Suspected or confirmed history of alcohol or drug abuse;
    • Hepatitis B surface antigen (HBsAg), HIV antibody detection, hepatitis C virus antibody (HCVAb), treponema pallidum specific antibody detection, positive;
    • Donation or loss of 200 mL or more of blood within 3 months prior to screening, or blood donation during screening or within 1 months after the end of the trial;
    • Pregnant or Breast-feeding women;
    • The investigator considers that the participant has any other factors that would make it inappropriate to participate in this study.

Who the study is looking for

  • √ Age 18-65 years on the date of signing informed consent (inclusive);
    • Body mass index (BMI) within the range of 19.0-30.0 kg/m2 (inclusive);.
    • Stable renal function, assessed by two eGFR during screening (apart at least 3 days);
    • Diagnosed as stable, chronic renal disease for at least 3 months.
    • Renal function, assessed by estimated glomerular filtration rate at screening (eGFR):
    • Normal renal function: 90-129 mL/min (inclusive);
    • Mild impairment: 60-89 mL/min (inclusive);
    • Moderate impairment: 30-59 mL/min (inclusive);
    • Severe impairment: 15-29 mL/min (inclusive);

Age in the registry: 18 years to 65 years · Sex: All · 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
The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital, Shandong Province)
Coordinator of this site? Confirm its status
JinanChinaUnknown status

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