The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital, Shandong Province)
Jinan, Shandong, 650100, China
NCT Number: NCT06929156
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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Notify Me18 year–65 year
All sexes
Interventional
Phase 1
Jinan, Shandong, 650100, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Receive a single dose of BGM0504 injection
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)
Time frame: Start of Treatment up to Day 29
Maximum Concentration of BGM0504 (Cmax)
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)
Time frame: Start of Treatment up to Day 29
Time to maximum concentration (Tmax)
Time frame: Start of Treatment up to Day 29
Apparent terminal half-life (t1/2)
Time frame: Start of Treatment up to Day 29
Apparent clearance (CL/F)
Time frame: Screening period up to Day 29
Incidence and severity of adverse events
BrightGene Bio-Medical Technology Co., Ltd.
Industry
A Multi-center, Single-dose, Open-label, Parallel Design, Pharmacokinetics Study of BGM0504 Injection in Healthy Participants and Participants With Impaired Renal Function
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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