A Study to Evaluate the Pharmacokinetics, Safety and Immunogenicity of BIIB800 Subcutaneously (SC) Compared to Actemra® in Healthy Male Participants
1상
완료
NCT06262477
| 대상 질환 | Healthy Volunteer |
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| 임상 단계 | 1상 |
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| 스폰서 | Biogen |
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| 상태 | 완료 |
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| 참여자 수 | 300 명 |
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| 중재(약물) | BIIB800, Actemra |
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| 시작일 | 2024년 1월 2일 |
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| 완료일 | 2024년 9월 25일 |
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| 결과 공개일 | 2025년 10월 6일 |
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요약
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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BENITIONS에서 보기
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