CompletedPhase 1

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

China34 participantsStarted 2025-05-06

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. 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);

What they're measuring

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

Timeframe: Start of Treatment up to Day 29

Maximum Concentration of BGM0504 (Cmax)

Timeframe: Start of Treatment up to Day 29

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

Timeframe: Start of Treatment up to Day 29

Trial details

NCT IDNCT06929156

SponsorBrightGene Bio-Medical Technology Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-25

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