A Crossover Study to Evaluate Pegilodecakin (LY3500518) in Healthy Participants
Фаза 1
Завершено
NCT04194892
| Заболевание | Healthy Adult Subjects |
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| Фаза | Фаза 1 |
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| Спонсор | Eli Lilly and Company |
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| Статус | Завершено |
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| Участники | 12 участн. |
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| Вмешательство | Pegilodecakin |
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| Дата начала | 19.01.2018 |
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| Дата завершения | 14.03.2018 |
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| Публикация результатов | 13.07.2026 |
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Кратко
The purpose of this study is to assess how fast pegilodecakin gets into the blood stream and how long it takes the body to remove it, when given as a solution formulation via a prefilled syringe (PFS) versus from a vial drawn into a conventional syringe. Information about side effects will be collected. The study is open to healthy participants. Total participant duration in trial is approximately 42 days.
Pharmacokinetic (PK): Maximum Drug Concentration (Cmax) of Pegilodecakin
Period 1: Days 1 to 4 and Day 8 (Predose, 2, 4, 8, 12, 16, 24, 36, 48, 72, and 168 hours post-dose (Day 8-predose)), Period 2: Days 8 to 11 and Day 15 (Predose, 2, 4, 8, 12, 16, 24, 36, 48, 72, and 168 hours post-dose) · picogram per milliliter (pg/mL)
| Pegilodecakin Vial | 9050 ± 93.7 picogram per milliliter (pg/mL) |
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| Pegilodecakin Pre-filled Syringe (PFS) | 12000 ± 111 picogram per milliliter (pg/mL) |
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PK: Time of Maximum Concentration (Tmax) of Pegilodecakin
Period 1: Days 1 to 4 and Day 8 (Predose, 2, 4, 8, 12, 16, 24, 36, 48, 72, and 168 hours post-dose (Day 8-predose)), Period 2: Days 8 to 11 and Day 15 (Predose, 2, 4, 8, 12, 16, 24, 36, 48, 72, and 168 hours post-dose) · hours
| Pegilodecakin Vial | 12.00 hours |
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| Pegilodecakin Pre-filled Syringe (PFS) | 12.00 hours |
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PK: Area Under the Serum Concentration Versus Time Curve From Time Zero to Infinity AUC[0-inf] of Pegilodecakin
Period 1: Days 1 to 4 and Day 8 (Predose, 2, 4, 8, 12, 16, 24, 36, 48, 72, and 168 hours post-dose (Day 8-predose)), Period 2: Days 8 to 11 and Day 15 (Predose, 2, 4, 8, 12, 16, 24, 36, 48, 72, and 168 hours post-dose) · hour*picogram per milliliter (h*pg/mL)
| Pegilodecakin Vial | 304000 ± 66.6 hour*picogram per milliliter (h*pg/mL) |
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| Pegilodecakin Pre-filled Syringe (PFS) | 457000 ± 62.8 hour*picogram per milliliter (h*pg/mL) |
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