A Study of TAK-881 and HyQvia in Healthy Adults
Фаза 1
Завершено
NCT06895967
| Заболевание | Healthy Volunteers |
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| Фаза | Фаза 1 |
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| Спонсор | Takeda |
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| Статус | Завершено |
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| Участники | 30 участн. |
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| Вмешательство | TAK-881, HyQvia, SC Investigational Needle Sets, SC Investigational Needle Sets |
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| Дата начала | 24.03.2025 |
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| Дата завершения | 24.07.2025 |
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| Публикация результатов | 11.05.2026 |
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Кратко
The main aim of this study is to understand how the body absorbs, processes, and removes (known as pharmacokinetics or PK) TAK-881 and HyQvia, after they are given as a single injection under the skin in healthy adults. Study participants will receive a single dose of TAK-881 or HyQvia on Day 1. During the study, participants will need to stay at the clinic for 8 days followed by 8 ambulatory follow up visits till Day 85.
Baseline-corrected Area Under the Concentration-time Curve (AUC) From Day 1 to Day 29 (AUC Day 1-29) Based on Serum Total Immunoglobulin G (IgG) Levels
Day 1 up to Day 29 · gram*hour per liter (g*h/L)
| TAK-881 1.0 g/kg | 2993 ± 13.6 gram*hour per liter (g*h/L) |
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| HyQvia 1.0 g/kg | 3190 ± 25.4 gram*hour per liter (g*h/L) |
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| Geometric mean ratio | 93.82 (95% CI 80.38–109.52) |
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