At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 300 enrolled
Drug / intervention
BIIB800 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Parallel-Group, Phase I Study to Evaluate the Pharmacokinetics, Safety and Immunogenicity of BIIB800 s.c. Compared to Actemra® in Healthy Male Participants
In Brief
A Phase 1 clinical trial evaluating BIIB800 and Actemra for Healthy Volunteer. Completed, enrolled 300 participants across 4 sites in 2 countries.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteer
CountriesUnited Kingdom, United States
Collaborators--
Timeline
Phase 1CompletedFinished
202420252026
Enrollment StartJan 2024
First PostedFeb 2024
Primary CompletionSep 2024
Study CompletionOct 2024
TodayJul 2026
First PostedFeb 16, 2024
Enrollment StartJan 2, 2024
Primary CompletionSep 25, 2024
Study CompletionOct 4, 2024
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 2.4 years ago
Interventions
BIIB800drug
Administered as specified in the treatment arm.
Actemradrug
Administered as specified in the treatment arm.