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NCT06262477

A Study to Evaluate the Pharmacokinetics, Safety and Immunogenicity of BIIB800 Subcutaneously (SC) Compared to Actemra® in Healthy Male Participants

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
Biogen·Phase 1·ClinicalTrials.gov·drugRecruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Healthy Volunteer
Drug/Device/Intervention
BIIB800
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Biogen
Location
Madison, United States of America
Timeline & enrollment
Phase
Phase 1
Start date
Jan 02, 2024
End date
Nov 30, 2024
Enrollment
300 participants
Primary outcome

Maximum Serum Concentration (Cmax) of Tocilizumab,Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Tocilizumab,Area Under the Concentration-Time Curve up to the Last Measurable Concentration (AUC0-t) of Tocilizumab

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.

ICD-10 classifications
Healthy person accompanying sick personRoutine general health check-up of armed forcesPersons encountering health services in other circumstancesPersons encountering health services in other circumstancesPerson encountering health services in unspecified circumstances
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06262477
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06262477 through Pure Global AI's free database. This Phase 1 trial is sponsored by Biogen and is currently Recruiting. The study focuses on Healthy Volunteer. Target enrollment is 300 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.