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Monoclonal Antibodies

BIIB800 vs Actemra for Healthy Subjects

Phase 1
Recruiting
Research Sponsored by Biogen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Must not have
Any prior exposure to tocilizumab or to any other agent directly acting on IL-6 or on its receptors including investigational products
History of immunodeficiency or other clinically significant immunological disorders, or autoimmune disorders
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to compare how a new drug, BIIB800, works in the body compared to an existing drug, Actemra, in healthy male participants. The study will look at how the

Who is the study for?
This trial is for healthy male participants. Specific eligibility criteria are not provided, but typically, this means individuals without significant health issues who meet the study's age and other demographic requirements.
What is being tested?
The trial is testing BIIB800 compared to Actemra when given as a single subcutaneous (under the skin) injection. It aims to show that BIIB800 has similar body absorption and action over time as Actemra does, along with assessing safety and immune response.
What are the potential side effects?
While specific side effects are not listed, common ones for medications like BIIB800 and Actemra may include reactions at the injection site, headaches, elevated liver enzymes, or allergic responses.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have never used tocilizumab or drugs targeting IL-6 for my condition.
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I have a history of immune system problems or autoimmune disorders.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: BIIB800Experimental Treatment1 Intervention
Participants will receive a single dose of BIIB800 via autoinjector, administered SC in the outer area of the upper arm on Day 1 of the study.
Group II: ActemraExperimental Treatment1 Intervention
Participants will receive a single dose of Actemra via autoinjector, administered SC in the outer area of the upper arm on Day 1 of the study.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

BiogenLead Sponsor
646 Previous Clinical Trials
467,213 Total Patients Enrolled
Medical DirectorStudy DirectorBiogen
2,889 Previous Clinical Trials
8,088,893 Total Patients Enrolled
~0 spots leftby Nov 2024
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