Single Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15912(Sonefpeglutide) in Healthy Korean Subjects
Фаза 1
Завершено
NCT04076293
| Заболевание | Pharmacology |
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| Фаза | Фаза 1 |
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| Спонсор | Hanmi Pharmaceutical Company Limited |
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| Статус | Завершено |
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| Участники | 40 участн. |
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| Вмешательство | HM15912 |
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| Дата начала | 8.10.2019 |
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| Дата завершения | 10.11.2020 |
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| Публикация результатов | 10.02.2025 |
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Кратко
A First-in-Human, Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15912 in Healthy Korean Subjects
Number of Participants With Treatment-emergent Adverse Events of HM15912
after single subcutaneous (SC) doses for 44 days · Participants
| HM15912 0.05mg/kg | 3 Participants |
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| HM15912 0.1mg/kg | 1 Participants |
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| HM15912 0.5mg/kg | 2 Participants |
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| HM15912 1.0mg/kg | 4 Participants |
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| HM15912 1.5mg/kg | 4 Participants |
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| Placebo | 5 Participants |
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Number of Participants With Significant Findings Observed for Hematology
after single subcutaneous (SC) doses for 44 days · Participants
| HM15912 0.05mg/kg | 0 Participants |
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| HM15912 0.1mg/kg | 0 Participants |
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| HM15912 0.5mg/kg | 0 Participants |
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| HM15912 1.0mg/kg | 0 Participants |
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| HM15912 1.5mg/kg | 0 Participants |
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| Placebo | 0 Participants |
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