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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Biogen · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	BIIB800	Administered as specified in the treatment arm.
DRUG	Actemra	Administered as specified in the treatment arm.

Timeline

• Start date: 2024-01-02
• Primary completion: 2024-09-25
• Completion: 2024-10-04
• First posted: 2024-02-16
• Last updated: 2025-10-06
• Results posted: 2025-10-06

Locations

4 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated drug study