To Compare the PK and Safety of Omalizumab (CT-P39, EU-approved Xolair, and US-licensed Xolair) in Healthy Subjects
Phase 1
Completed
NCT04018313
| Condition | Healthy |
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| Phase | Phase 1 |
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| Sponsor | Celltrion |
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| Status | Completed |
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| Enrollment | 176 participants |
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| Interventions | CT-P39, EU-approved Xolair, CT-P39, EU-approved Xolair, US-licensed Xolair |
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| Start date | May 28, 2020 |
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| Completion date | Mar 27, 2021 |
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| Results posted | May 11, 2023 |
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Summary
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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