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Monoclonal Antibodies

BIIB800 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from screening up to day 57

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from screening up to day 57

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from screening up to day 57

This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening up to day 57 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Maximum Serum Concentration (Cmax) of Tocilizumab

Secondary outcome measures

AUE of High Sensitive C-Reactive Protein (hsCRP)

Apparent Terminal Half-Life (t1/2) of BIIB800 and Tocilizumab

Apparent Total Body Clearance (CL/F) of BIIB800 and Tocilizumab

+9 more

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.

Do I qualify?Apply below to find out

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

BiogenLead Sponsor

639 Previous Clinical Trials

467,022 Total Patients Enrolled

Medical DirectorStudy DirectorBiogen

2,777 Previous Clinical Trials

8,064,104 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment process currently in progress for participants of this research study?

"The trial is actively seeking participants as indicated on clinicaltrials.gov. The study was first published on January 2nd, 2024 and last revised on February 8th, 2024."

Answered by AI

What is the safety profile of BIIB800 in individuals?

"Given that this is a Phase 1 trial with limited safety and efficacy data available, BIIB800 received a safety rating of 1 on the scale from 1 to 3 by our team at Power."

Answered by AI

Do I meet the requirements to participate in this research endeavor?

"To qualify for this research study, individuals must be in good health and aged between 18 to 55 years old. The trial is currently seeking approximately 300 eligible participants."

Answered by AI

What is the current number of individuals being admitted into this particular medical trial?

"Affirmative. Information available on clinicaltrials.gov confirms the ongoing recruitment of participants for this particular investigation. The trial was first listed on January 2nd, 2024 and its latest update was recorded on February 8th, 2024. The study aims to enlist a total of 300 patients from one designated site."

Answered by AI

Could individuals younger than 80 years old participate in this research study?

"To be eligible for this clinical investigation, candidates must fall within the age bracket of 18 to 55 years. It is notable that there are numerous ongoing studies catering specifically to individuals under 18 and those surpassing the age of 65 - a total of 65 trials for pediatric patients and 379 trials targeting geriatric populations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "A Study to Evaluate the Pharmacokinetics, Safety and Immunogenicity of BIIB800 Subcutaneously (SC) Compared to Actemra® in Healthy Male Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06262477.

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