To Compare the PK and Safety of Omalizumab (CT-P39, EU-approved Xolair, and US-licensed Xolair) in Healthy Subjects
1期
已完成
NCT04018313
| 适应症 | Healthy |
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| 分期 | 1期 |
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| 申办方 | Celltrion |
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| 状态 | 已完成 |
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| 受试者人数 | 176 人 |
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| 干预（药物） | CT-P39, EU-approved Xolair, CT-P39, EU-approved Xolair, US-licensed Xolair |
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| 开始日期 | 2020年5月28日 |
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| 完成日期 | 2021年3月27日 |
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| 结果公布日 | 2023年5月11日 |
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摘要
A Phase 1, Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of Three Formulations of Omalizumab (CT-P39, EU-approved Xolair, and US-licensed Xolair) in Healthy Subjects
Pharmacokinetic Outcome Measures [AUC0-inf] for Part 2
up to day 127 · day*μg/mL
| CT-P39 (Part 2) | 910.9 ± 278.57 day*μg/mL |
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| EU-approved Xolair (Part 2) | 897.7 ± 270.25 day*μg/mL |
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| US-licensed Xolair (Part 2) | 926.3 ± 273.30 day*μg/mL |
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| Ratio of geometric least square means | 105.62 (95% CI 95.91–116.31) |
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Pharmacokinetic Outcome Measures [AUC0-last] for Part 2
up to day 127 · day*μg/mL
| CT-P39 (Part 2) | 846 ± 251.87 day*μg/mL |
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| EU-approved Xolair (Part 2) | 843.8 ± 248.04 day*μg/mL |
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| US-licensed Xolair (Part 2) | 850.0 ± 213.13 day*μg/mL |
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| Ratio of geometric least square means | 104.00 (95% CI 94.96–113.89) |
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Pharmacokinetic Outcome Measures [Cmax] for Part 2
up to day 127 · μg/mL
| CT-P39 (Part 2) | 20.08 ± 5.9940 μg/mL |
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| EU-approved Xolair (Part 2) | 18.24 ± 4.9981 μg/mL |
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| US-licensed Xolair (Part 2) | 19.43 ± 5.4159 μg/mL |
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| Ratio of geometric least square means | 113.14 (95% CI 103.15–124.11) |
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本页整理自 ClinicalTrials.gov 的公开数据，不构成医疗建议，也不构成投资建议。请务必咨询专业医师。