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OpenTrials
Completed

NCT Number: NCT06929156

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital, Shandong Province)

Jinan, Shandong, 650100, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • √ 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);

Exclusion criteria

  • ● 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.

Treatment and study plan

BGM0504

Drug

Receive a single dose of BGM0504 injection

Primary outcomes

  1. Area Under the Concentration Versus Time Curve (AUC) of BGM0504 From Time Zero to Tlast (AUC0-t)

    Time frame: Start of Treatment up to Day 29

    Area Under the Concentration Versus Time Curve (AUC) of BGM0504 From Time Zero to Tlast (AUC0-t)

  2. Maximum Concentration of BGM0504 (Cmax)

    Time frame: Start of Treatment up to Day 29

    Maximum Concentration of BGM0504 (Cmax)

  3. Area Under the Concentration Versus Time Curve (AUC) of BGM0504 From Time Zero to Infinity (AUC0-inf)

    Time frame: Start of Treatment up to Day 29

    Area Under the Concentration Versus Time Curve (AUC) of BGM0504 From Time Zero to Infinity (AUC0-inf)

Secondary outcomes

  1. Time to maximum concentration (Tmax)

    Time frame: Start of Treatment up to Day 29

    Time to maximum concentration (Tmax)

  2. Apparent terminal half-life (t1/2)

    Time frame: Start of Treatment up to Day 29

    Apparent terminal half-life (t1/2)

  3. Apparent clearance (CL/F)

    Time frame: Start of Treatment up to Day 29

    Apparent clearance (CL/F)

  4. Incidence and severity of adverse events

    Time frame: Screening period up to Day 29

    Incidence and severity of adverse events

Sponsors and collaborators

Lead sponsor

BrightGene Bio-Medical Technology Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 16, 2025
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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