A Crossover Study to Evaluate Pegilodecakin (LY3500518) in Healthy Participants
第1相
完了
NCT04194892
| 対象疾患 | Healthy Adult Subjects |
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| 相 | 第1相 |
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| スポンサー | Eli Lilly and Company |
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| ステータス | 完了 |
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| 参加者数 | 12 名 |
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| 介入（薬剤） | Pegilodecakin |
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| 開始日 | 2018年1月19日 |
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| 完了日 | 2018年3月14日 |
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| 結果公開日 | 2026年7月13日 |
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概要
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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