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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:

• √ 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);

Locations
Other Locations
China
The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital, Shandong Province)
RECRUITING
Jinan
Contact Information
Primary
Wei Zhao
Zhao4wei2@hotmail.com
860531-82921552
Time Frame
Start Date: 2025-05-08
Estimated Completion Date: 2025-11-30
Participants
Target number of participants: 32
Treatments
Experimental: A group (Healthy Control)
Experimental: B group (Mild Renal Impairment)
Experimental: C group (Moderate Renal Impairment)
Experimental: D group (Severe Renal Impairment)
Related Therapeutic Areas
Sponsors
Leads: BrightGene Bio-Medical Technology Co., Ltd.

This content was sourced from clinicaltrials.gov

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