A Study to Evaluate the Pharmacokinetics, Safety and Immunogenicity of BIIB800 Subcutaneously (SC) Compared to Actemra® in Healthy Male Participants
1期
已完成
NCT06262477
| 适应症 | Healthy Volunteer |
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| 分期 | 1期 |
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| 申办方 | Biogen |
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| 状态 | 已完成 |
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| 受试者人数 | 300 人 |
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| 干预（药物） | BIIB800, Actemra |
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| 开始日期 | 2024年1月2日 |
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| 完成日期 | 2024年9月25日 |
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| 结果公布日 | 2025年10月6日 |
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摘要
The primary objective of the study is to show equivalence in pharmacokinetics (PK) of BIIB800 and Actemra following SC administration of a single dose to healthy male participants. The secondary objective of the study is to evaluate PK over time, clinical safety, pharmacodynamic (PD) profiles and immunogenicity of BIIB800 and Actemra.
Maximum Observed Serum Concentration (Cmax) of Tocilizumab
Pre-dose on Day 1 and multiple time points post-dose (up to Day 57) · micrograms per milliter (μg/mL)
| BIIB800 | 10.5 ± 43.3 micrograms per milliter (μg/mL) |
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| Actemra | 10.0 ± 41.3 micrograms per milliter (μg/mL) |
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| Ratio of GLSM | 1.05 (95% CI 0.974–1.13) |
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Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Tocilizumab
Pre-dose on Day 1 and multiple time points post-dose (up to Day 57) · hours (h)*μg/ mL
| BIIB800 | 2380 ± 44.9 hours (h)*μg/ mL |
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| Actemra | 2240 ± 41.1 hours (h)*μg/ mL |
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| Ratio of GLSM | 1.07 (95% CI 0.988–1.15) |
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Area Under the Concentration-Time Curve up to the Last Measurable Concentration (AUC0-t) of Tocilizumab
Pre-dose on Day 1 and multiple time points post-dose (up to Day 57) · h*μg/ mL
| BIIB800 | 2120 ± 45.9 h*μg/ mL |
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| Actemra | 2000 ± 44.0 h*μg/ mL |
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| Ratio of GLSM | 1.06 (95% CI 0.985–1.15) |
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