Phase 1 Study of PK and Safety of HM15912 (Sonefpeglutide) in Subjects With Normal and Severe Kidney Function
1期
已完成
NCT05711381
| 适应症 | Renal Impairment |
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| 分期 | 1期 |
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| 申办方 | Hanmi Pharmaceutical Company Limited |
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| 状态 | 已完成 |
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| 受试者人数 | 16 人 |
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| 干预（药物） | HM15912 |
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| 开始日期 | 2022年12月2日 |
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| 完成日期 | 2023年8月15日 |
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| 结果公布日 | 2025年4月4日 |
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摘要
An Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HM15912 in Subjects with Renal Impairment and Matched Control Subjects with Normal Renal Function
Maximum Serum Concentration (Cmax) of HM15912
Day 1 to 29 (Total duration: 29 days) · ng/mL
| Severe Renal Impairment | 2811.25 ± 1498.985 ng/mL |
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| Normal Renal Function | 3000.00 ± 1174.114 ng/mL |
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| Geometric mean ratio | 0.91 (95% CI 0.59–1.41) |
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Area Under the Concentration-time Curve From Extrapolated to Infinity (AUC 0-infinity) of HM15912
Day 1 to 29 (Total duration: 29 days) · h*ng/mL
| Severe Renal Impairment | 1117469.3 ± 347572.67 h*ng/mL |
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| Normal Renal Function | 890343.8 ± 235565.36 h*ng/mL |
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| Geometric mean ratio | 1.25 (95% CI 0.93–1.68) |
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